Agenda
Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
Aseptic 101
Aseptic processing is an important part of the pharmaceutical industry, and it can be confusing to know where to start. That’s why we’re holding this introductory session – so you can learn about ISPE, sterile manufacturing methods, and everything else related to aseptic processing. You’ll hear from experts in the field and have the opportunity to ask questions. All attendees are welcome, but this session is tailored more specifically to students, emerging leaders, young professionals, first time attendees, or those needing additional insight into all things Aseptic.
Sunday, 16 March 1500 – 1700
Filters
Mon, 17 Mar
Tue, 18 Mar
0730 – 1930
Registration open: Monday, 17 March 0730-1900 ET. Registration will also be open on Sunday, 16 March from 1300-1700 ET.
0730 – 0830
Networking
0830 – 0850
General Session
0850 – 0920
Description Coming Soon.
0920 – 0950
Description Coming Soon.
0950 – 1000
1000 – 1045
Networking
1045 – 1115
The revision and approval of EU Annex 1 have captured key aseptic processing expectations by regulators for the industry and have challenged the industry to continue to advance technologies to improve the aseptic processing of sterile drug products. This presentation will outline Lilly's "One Lilly Voice" initiative, which engaged in industry work to comment on draft versions of Annex 1, assess and implement Annex 1, and the continued engagement in the industry in the monitoring and continuous improvement of Lilly standards and practices to meet regulatory expectations from Annex 1.
1045 – 1115
Advanced Modalities
Aleksandra Pekosak, PhD, Kyowa Kirin
The past two years have posed significant challenges for the majority of sterile manufacturers, spanning from small CMOs to bigger global players. For European MAHs with sterile manufacturing operations distributed globally, ensuring regulatory compliance and navigating diverse cultural working environments necessitates unique approaches.
This presentation will detail how a Japan-based global specialty pharmaceutical company addressed Annex 1 compliance at CMOs and internal manufacturing sites, and provide practical examples from audits learnings, addressing risks identified up to the overall Annex 1 compliance.
Furthermore, the talk will also discuss how companies oversaw CMOs Annex 1 compliance and how QP have been approaching batch certification through their continuous involvement in Annex 1 readiness activities.
1045 – 1115
Regulations and Pharma 4.0
Jorge Delgado, Amgen
Jonathan Malave, Amgen
Deep Learning (DL), a transformative technology based on Deep Neural Networks, is revolutionizing Automatic Visual Inspection (AVI), enhancing accuracy and efficiency. According to USP 790>, all parenteral products must be visually inspected for particulates. While AVI can replace manual inspection, traditional systems face challenges differentiating between acceptable product features and defects, leading to high false rejection rates (2-20%). DL addresses these challenges by leveraging high-volume processing capabilities for rapid, precise image analysis. Applications include distinguishing bubbles from particulate matter, cosmetic scratches from real defects, and more, significantly improving defect detection in challenging areas like syringe shoulders and vial heels.
Key outcomes include a superior detection rate (>99%) and a false eject rate of 1%, marking a substantial improvement over current AVI technology. DL's advancements in machine vision, processing power, and data storage have enabled its use in commercial AVI, enhancing detectability even with limited views. The future of AVI with DL involves continuous model refinement, reducing development time and implementation costs. Benefits include increased efficiency, enhanced asset longevity, and faster market readiness for new products. This innovative approach will set a new industry standard for AVI.
The presentation will outline the problem with current visual inspection methods for parenteral drug products. It will provide a brief overview of Deep Learning technology and its implementation in a regulatory environment. Finally, the presentation will share the results achieved from this technological implementation.
Key outcomes include a superior detection rate (>99%) and a false eject rate of 1%, marking a substantial improvement over current AVI technology. DL's advancements in machine vision, processing power, and data storage have enabled its use in commercial AVI, enhancing detectability even with limited views. The future of AVI with DL involves continuous model refinement, reducing development time and implementation costs. Benefits include increased efficiency, enhanced asset longevity, and faster market readiness for new products. This innovative approach will set a new industry standard for AVI.
The presentation will outline the problem with current visual inspection methods for parenteral drug products. It will provide a brief overview of Deep Learning technology and its implementation in a regulatory environment. Finally, the presentation will share the results achieved from this technological implementation.
1115 – 1145
Regulations and Pharma 4.0
Max Scheible, PhD, Vetter Pharma-Fertigung GmbH & Co KG
Automated Visual Inspection (AVI) presents an alternative to the industry standard of inspection by human operators. Using state-of-the-art technologies AVI enables a robust and reproducible process, but also lacks of flexibility and comes along with large efforts for qualification. This session focuses on the basic principles of inspection machines and what needs to be done to transfer products from manual to AVI. A fundamental understanding is given by discussing the the differences between camera and human and how this contrast can be solved based on statistics. Following the regulatory guidelines, it is shown how to implement new products to AVI based on common industry practices.
1115 – 1145
Advanced Modalities
Brooke Jenkins, LOTTE Biologics
Ashley Harp, CRB
The presentation will address regulatory, compliance, and quality by highlighting innovative solutions and best practices for the manufacturing of Antibody-Drug Conjugates through a case study. We will talk to comprehensive risk assessments conducted throughout the design process, showcasing their role in identifying and mitigating potential hazards. This approach ensures both product safety and personnel protection. Furthermore, we will discuss the evolving regulatory landscape, presenting specific tools and guidelines that help navigate the requirements for ADC production. Emphasizing sustainable practices, we will explore the use of advanced containment strategies and materials, assessing their impact on environmental sustainability and compliance. By demonstrating these approaches through a detailed case study, the presentation aims to provide insights for enhancing safety, regulatory adherence, and quality in ADC manufacturing.
1115 – 1145
Explore the future of aseptic manufacturing firsthand with a virtual tour of Kindeva's state-of-the-art Bridgeton, Missouri facility. Recently completed in 2024, this cutting-edge sterile fill-finish site spans over 155,000 sq. ft. and features dedicated aseptic operations, labs, formulation suites, and 11,000 sq. ft. of advanced fill suites. Attendees will navigate through the facility, gaining insights into the strategic decisions that enabled its design, construction, and rapid operationalization within just one year.
Highlights of the new Annex 1-compliant facility include automated isolated fillers for NTT and PUPSIT testing, electronic batch records, single-use systems, and versatile capabilities for syringes, cartridges, and vials. The session will also showcase the facility's utilization of virtual reality modeling for design, training, and marketing purposes, setting a new standard for efficient, high-tech aseptic facility construction.
This virtual tour and case study will offer valuable insights into the collaborative efforts and strategic planning that drove the success of the Kindeva project emphasizing automation, regulatory compliance, and operational excellence amidst evolving market demands.
Highlights of the new Annex 1-compliant facility include automated isolated fillers for NTT and PUPSIT testing, electronic batch records, single-use systems, and versatile capabilities for syringes, cartridges, and vials. The session will also showcase the facility's utilization of virtual reality modeling for design, training, and marketing purposes, setting a new standard for efficient, high-tech aseptic facility construction.
This virtual tour and case study will offer valuable insights into the collaborative efforts and strategic planning that drove the success of the Kindeva project emphasizing automation, regulatory compliance, and operational excellence amidst evolving market demands.
1145 – 1215
Regulations and Pharma 4.0
Jai Pathak, PhD, Astrazeneca Limited Partnership
Automatic Visual Inspection is a mature field in our industry, which is heavily influenced by science field diverse as optics, physics, pharmacy and also by regulations, pharmacopeias and technological developments. In this presentation, some case studies will be presented on products with low fill volume in a 10 R vial, which led to challenges with high false rejects. We will describe how these challenges were met, and how these lessons were applied to the next product in this family, where the choice of the vial & fill volume, was influenced by previous lessons. We will also discuss the experiences in inspecting low fill vol. (0.5 mL) in a nominal 1.0 mL fill volume pre-filled syringe by AVI. Some practical lessons learned and best practices will be shared with the peer community.
1145 – 1215
Advanced Modalities
Ralf Klotz, Optima Machinery Corporation
Kreena Patel, Merk
This presentation will showcase how to design a flexible ADC filling line for clinical supply through videos and other visualizations, such as 3d models and photos.
The presentation will allow the attendees to understand the key design criteria of a planned, new ADC facility as it relates to equipment design, vendor selection, facility design, and how that relates to process flow, product flow, and personnel flow.
The presentation will cover primary design considerations, including regulatory compliance, technology, flexibility, scalability, implementation, maintaining schedule, and staying on budget/cost. The presenter will also discuss the key elements to consider for protecting personnel and the product while maintaining efficiency for dependable operation and a robust, repeatable process. All the while ensuring that the production can be scaled out and scaled up as applicable with the ability to flex to market demands.
The presentation will allow the attendees to understand the key design criteria of a planned, new ADC facility as it relates to equipment design, vendor selection, facility design, and how that relates to process flow, product flow, and personnel flow.
The presentation will cover primary design considerations, including regulatory compliance, technology, flexibility, scalability, implementation, maintaining schedule, and staying on budget/cost. The presenter will also discuss the key elements to consider for protecting personnel and the product while maintaining efficiency for dependable operation and a robust, repeatable process. All the while ensuring that the production can be scaled out and scaled up as applicable with the ability to flex to market demands.
1145 – 1215
Case Studies
Henning Austermann, Siegfried Hameln
Klaus Ullherr, Syntegon Technology GmbH
In the evolving pharmaceutical landscape, Contract Development and Manufacturing Organizations (CDMOs) play a pivotal role in responding to dynamic market demands. This presentation showcases a case study on Siegfried Hameln, a leading CDMO, and their strategic expansion into the production and fill-finish of syringes and cartridges.
The presentation highlights:
- The seamless integration of a state-of-the-art fill finish solution within an existing production environment
- Key technical features of the machine
- Packstyle flexibility, enabling rapid adaptation to changing market requirements
- No-touch-transfer system ensuring sterility and contamination control
- 100% in-process control (IPC) enhancing product quality and compliance
- Integration of in-air isolator
- Operational efficiency with peristaltic pump with single-use filling systems
- Practical implementation of Annex 1 requirements
The presentation highlights:
- The seamless integration of a state-of-the-art fill finish solution within an existing production environment
- Key technical features of the machine
- Packstyle flexibility, enabling rapid adaptation to changing market requirements
- No-touch-transfer system ensuring sterility and contamination control
- 100% in-process control (IPC) enhancing product quality and compliance
- Integration of in-air isolator
- Operational efficiency with peristaltic pump with single-use filling systems
- Practical implementation of Annex 1 requirements
1215 – 1345
Networking
1345 – 1415
Case Studies
Henrik Hermann, FujiFilm
Anders Magnusson, Cambrex Karlskoga AB
Matthias Poslovski, OPTIMA Pharma GmbH
Isolator Filling Line with Conventional and Real-Time Viable Environmental Monitoring
The latest update to the EU GMP Annex 1 regulation (2022) has prompted the need for improved environmental monitoring solutions in sterile medicinal product manufacturing. Real time environmental monitoring solutions like biofluorescent particle counters (BFPCs) can help to gain immediate insights, to address and mitigate contamination risks, increase operational efficiency, and enhance compliance.
The presentation will explore the integration of conventional and real time viable monitoring into an isolator fill & finish line for syringes, vials, and cartridges and give detailed insights into the perspective of machine manufacturers and pharmaceutical companies. The challenges and lessons learned during integration are discussed, as well as the strategy for a parallel setup for conventional and real-time monitoring. Integration into the SCADA system and considerations for the mockup system are also taken into account.
In addition, operational aspects will be shown like challenge tests, interventions, in case of a hit or calibration. The regulatory approach and related experiences will be presented, as well as the validation and demonstration of comparable (superior performance (CFU vs. AFU).
The latest update to the EU GMP Annex 1 regulation (2022) has prompted the need for improved environmental monitoring solutions in sterile medicinal product manufacturing. Real time environmental monitoring solutions like biofluorescent particle counters (BFPCs) can help to gain immediate insights, to address and mitigate contamination risks, increase operational efficiency, and enhance compliance.
The presentation will explore the integration of conventional and real time viable monitoring into an isolator fill & finish line for syringes, vials, and cartridges and give detailed insights into the perspective of machine manufacturers and pharmaceutical companies. The challenges and lessons learned during integration are discussed, as well as the strategy for a parallel setup for conventional and real-time monitoring. Integration into the SCADA system and considerations for the mockup system are also taken into account.
In addition, operational aspects will be shown like challenge tests, interventions, in case of a hit or calibration. The regulatory approach and related experiences will be presented, as well as the validation and demonstration of comparable (superior performance (CFU vs. AFU).
1345 – 1415
Filling Operations
Johannes Rauschnabel, PhD, Syntegon Technology GmbH
Annex 1 calls for attention to contamination prevention at transfers of pack styles and components into an aseptic fill finish environment (grade A). Technology has moved forward and provides several options of automated debagging and transfer solutions for Ready-to-Use (RtU) primary packaging material.
One is sterilization/bio-decontamination with validated 4-6 log reduction of debagged RtU-tubs by Electron-Beam (eBeam) or disinfectant exposure. Other solutions are touchless approaches, such as No-Touch-Transfer (NTT), based on automatic or semi-automatic debagging steps in combination with different cleanroom settings and supportive airflow designs (e.g., C-, B- environment, and UAF combination). Depending on the robustness of processes, bag opening technology, and choice of barrier system (RABS and isolator – closed as well as open isolators), different challenges to cleanroom quality occur.
A Quality Risk Management approach is essential to evaluating technical solutions and process designs (from eBeam to touch-free). This includes strategies for prevention and safe interventions in case of process problems. The presentation does address not only new fill/finish line designs but also practical solutions for an installed base that comply with Annex 1 regulatory expectations on safe transfers.
One is sterilization/bio-decontamination with validated 4-6 log reduction of debagged RtU-tubs by Electron-Beam (eBeam) or disinfectant exposure. Other solutions are touchless approaches, such as No-Touch-Transfer (NTT), based on automatic or semi-automatic debagging steps in combination with different cleanroom settings and supportive airflow designs (e.g., C-, B- environment, and UAF combination). Depending on the robustness of processes, bag opening technology, and choice of barrier system (RABS and isolator – closed as well as open isolators), different challenges to cleanroom quality occur.
A Quality Risk Management approach is essential to evaluating technical solutions and process designs (from eBeam to touch-free). This includes strategies for prevention and safe interventions in case of process problems. The presentation does address not only new fill/finish line designs but also practical solutions for an installed base that comply with Annex 1 regulatory expectations on safe transfers.
1345 – 1415
Sterility and Release
Alexandra Heussner, Vetter Pharma-Fertigung GmbH & Co KG
For package integrity studies of sterile products new technologies are increasingly attractive to fulfill regulatory requirements. Depending on the container-closure system, several deterministic and probabilistic leak test technologies may be used according to USP 1207>.
Dye ingress methods remain important parts of demonstrating container closure integrity (CCI) and thus maintaining the sterility of parenterals across the biopharmaceutical industry.
Highly sensitive analytical procedures are particularly useful for special applications such as development, risk assessments, or qualification of filling, assembling, or transportation processes of packaging combinations.
For this purpose, we developed a customized Fluorescein assay, which is capable of quantifying Fluorescein in aqueous solutions selectively, sensitively, accurately, precisely, and robustly.
As a CDMO, we need to address challenges posed by the huge varieties of package combinations, configurations, transportation, and storage needs. In particular, in the early development of the fill and finish processes of a new parental drug product, fast and easy analytical procedures can provide the needed support for developmental studies, finally leading to process validation.
This presentation will include the relevant details of a customized, highly sensitive analytical procedure, which is fit for that intended purpose and will provide examples of its application.
Dye ingress methods remain important parts of demonstrating container closure integrity (CCI) and thus maintaining the sterility of parenterals across the biopharmaceutical industry.
Highly sensitive analytical procedures are particularly useful for special applications such as development, risk assessments, or qualification of filling, assembling, or transportation processes of packaging combinations.
For this purpose, we developed a customized Fluorescein assay, which is capable of quantifying Fluorescein in aqueous solutions selectively, sensitively, accurately, precisely, and robustly.
As a CDMO, we need to address challenges posed by the huge varieties of package combinations, configurations, transportation, and storage needs. In particular, in the early development of the fill and finish processes of a new parental drug product, fast and easy analytical procedures can provide the needed support for developmental studies, finally leading to process validation.
This presentation will include the relevant details of a customized, highly sensitive analytical procedure, which is fit for that intended purpose and will provide examples of its application.
1415 – 1445
A case study of a CDMO, MilliporeSigma, moving from an aging RABS filling line to a SKAN/Bausch & Strobel Varyosis isolator line per Annex 1. This presentation will review challenges and successes with installing, validating and implementing a new isolator filling line including strategic regulatory filing strategies to assess moving commerical and clinical clients from the RABS to the isolator. A panel presentation with the manufacturing site, sterility assurance consultant supporting line aseptic readiness, Jeff Yuen (former FDA) regulatory strategy, and Merritt Postma SKAN isolator vendor.
Improved contamination control strategy results of validation and readiness of the isolator line will be reviewed.
1415 – 1445
Filling Operations
Patrick Wieland, Bausch+Ströbel SE + Co. KG
In pharmaceutical manufacturing, the fill and finish process is a critical stage that involves the final filling and packaging of drug products. Reducing glove interventions in this process is essential for minimizing contamination risks, improving product quality and enhancing operational efficiency.
Key challenges include ensuring compliance with stringent regulatory standards and integrating automated systems. However, the benefits of reducing glove interventions are substantial. Automation and advanced technologies, such as robotic systems and closed containment systems can significantly decrease human contact with sterile environments, thereby lowering the risk of contamination. Additionally, these solutions can lead to increased production quality, reduced downtime and enhanced process security. By adopting innovative fill and finish solutions, pharmaceutical companies can achieve higher standards of product safety and quality, while also optimizing their production processes.
1415 – 1445
Sterility and Release
Anthony Thatcher, Carsgen Therapeutics
Prethib Arumugam, Sumitomo Pharma America
Cell and Tissue based products by their nature are not sterile but must be carefully produced and tested to ensure they are aseptic. Not only the product itself but also the matrix (media, infusion buffer, and etc.) can have a significant impact on the effectiveness of the sterility testing methods. This presentation will explore special considerations developing sterility test methods and aseptic assurance for cell and tissue-based products. Alternative test methods for rapid assessment of aseptic products with short shelf lives will be presented. Finally a Q&A will be hosted at the end of the session to engage with the audience and share any responses to specific challenges attendees may be having in this area of testing.
1445 – 1515
Case Studies
Justin Svec, Eli Lilly & Co Mfg & Quality Learning Ctr
Peter Berzins, Eli Lilly and Co
The state of aseptic filling technology has been in a relative plateau in recent years, but there have been new novel technical advancements recently implemented for low speed, small batch applications. This presentation will give a case study for one such current novel advanced technological nested filling line, and will propose a landscape for future advances in aseptic filling technology.
1445 – 1515
Transferring materials from an autoclave to an isolator is a critical process in pharmaceuticals and biotechnology, where maintaining sterility and preventing contamination are paramount. This process involves several challenges that need careful consideration to ensure the integrity and safety of the materials. One of the primary challenges is maintaining sterility throughout the transfer. Autoclaves are designed to sterilize equipment and materials through high-pressure saturated steam, effectively eliminating microbial life. However, once the sterilization cycle is complete, transferring these sterile items into an isolator without compromising their sterility requires meticulous planning and execution. The session will go through:
- Material preparation
- Entry procedure
- Decontamination
- Transfer to isolator
- Final preparation
- Environmental monitoring
- Validation
- Material preparation
- Entry procedure
- Decontamination
- Transfer to isolator
- Final preparation
- Environmental monitoring
- Validation
1445 – 1515
ATP-based Alternative Microbial Methods for Product Quality Assessment of Biologic Drug Products
Microbial Enumeration Tests (USP 61>) and Sterility Tests (USP 71>) are compendial methods for meeting regulatory requirements of pharmaceutical product quality manufacturing in US markets. These methods are reliable and consistent; however, results can take approximately 5-7 days for bioburden testing and no less than 14 days for sterility tests. There is much attention within the pharmaceutical manufacturing industry on the adoption of alternative microbial detection methods that may provide an earlier time to result because the regulatory pathways to approval may appear more challenging than compendial methods. Non-compendial microbial detection approaches engender questions about risk from both sides of the table: investment risk of a failed implementation from Sponsors and risk to patient safety due to under-controlled product quality from regulatory authorities. The Agency has a vested interest in understanding performance challenges of emerging adventitious agent detection technology in comparison to compendial methods used in the manufacturing process of pharmaceuticals. This presentation will discuss current CDER research on alternative microbial detection methods that utilize an ATP-bioluminescence detection platform and implications for CDER regulated drug products.
Microbial Enumeration Tests (USP 61>) and Sterility Tests (USP 71>) are compendial methods for meeting regulatory requirements of pharmaceutical product quality manufacturing in US markets. These methods are reliable and consistent; however, results can take approximately 5-7 days for bioburden testing and no less than 14 days for sterility tests. There is much attention within the pharmaceutical manufacturing industry on the adoption of alternative microbial detection methods that may provide an earlier time to result because the regulatory pathways to approval may appear more challenging than compendial methods. Non-compendial microbial detection approaches engender questions about risk from both sides of the table: investment risk of a failed implementation from Sponsors and risk to patient safety due to under-controlled product quality from regulatory authorities. The Agency has a vested interest in understanding performance challenges of emerging adventitious agent detection technology in comparison to compendial methods used in the manufacturing process of pharmaceuticals. This presentation will discuss current CDER research on alternative microbial detection methods that utilize an ATP-bioluminescence detection platform and implications for CDER regulated drug products.
1515 – 1600
Networking
1600 – 1730
General Session
Richard Denk, SKAN AG
Norman Goldschmidt, Genesis AEC
Michael Higgins, Moderna
The 2022 revision to the EU/GMP and PIC/s Annex 1 is multifaceted, it’s broad scope and areas of focus may impact each organization differently. For one company the greatest impact may be in the expectations around airflow visualization studies, or material transfers into Grade A; another may need to focus on PUPSIT, or using Barriers such as RABS or Isolators; a third might be challenged to develop a robust QRM/ CCS. In this session industry leaders will discuss their view of Annex 1’s impact on different modalities, their experiences implementing changes to align with the revision, and how inspectors have reacted to these changes.
1730 – 1900
0730 – 0830
Networking
0730 – 1700
0830 – 0840
0840 – 0850
General Session
Raven Hawkins, SmithGroup
Lynne Cooper, El Sea & Critical Systems Inc.
0850 – 0920
The New Wave for Radiopharmaceuticals : Navigating the Next Frontier of Precision Medicine and Therapeutic Innovation
Since 2018, significant advancements have been made in the development and commercialization of radioligand therapies, presenting promising new pathways for therapies for both cancer and rare disease. Numerous studies utilizing alpha particles from Actinium-225, Lead-212 and Astatine-211 have demonstrated superior efficacies of these potential therapies against multiple cancer indications. However, questions remain the long-term supply chain and commercial promise of these early stage clinicals. This presentation will highlight the overall radioligand therapy market landscape, key isotopes and their potential application and key insights that are unique CMC matters for radioligand therapies and to what regulators are expecting from late-stage radiopharmaceutical companies to achieve regulatory approval.
0920 – 0950
Description Coming Soon.
0950 – 1000
1000 – 1045
Networking
1015 – 1045
Sterility and Release
Hirokazu Sugiyama, PhD, The University of Tokyo, Department of Chemical System Engineering
Koji Kawasaki, Airex Co., Ltd.
Recently, various H2O2 decontamination methods have emerged in the market.
Like many companies and research groups working on more efficient decontamination techniques, Airex has collaborated with the University of Tokyo to study the use of aerosolized H2O2 and ultrasonic diffusion.
Ultrasonic Brownian motion has been found to be a significant energy source for dispersing particles over greater distances. Since particles are dispersed solely through this Brownian motion without additional air circulation, H2O2 can be used more efficiently, significantly reducing the amount consumed in aseptic process condition.
This presentation aims to share and discuss these academic research findings with experts from related industries worldwide.
Like many companies and research groups working on more efficient decontamination techniques, Airex has collaborated with the University of Tokyo to study the use of aerosolized H2O2 and ultrasonic diffusion.
Ultrasonic Brownian motion has been found to be a significant energy source for dispersing particles over greater distances. Since particles are dispersed solely through this Brownian motion without additional air circulation, H2O2 can be used more efficiently, significantly reducing the amount consumed in aseptic process condition.
This presentation aims to share and discuss these academic research findings with experts from related industries worldwide.
1045 – 1115
Advanced Therapy Medicinal Products
Philip Ceary, AstraZeneca
Maddie Lawhorn, CRB
The development of autologous cell therapies presents unique manufacturing challenges, necessitating the implementation of robust resiliency and redundancy strategies to ensure consistent and reliable patient outcomes. As personalized medicine advances, the complexity of these patient-centric therapies underscores the need for uninterrupted production, supply chains, and methodologies for assessing risk.
This presentation explores the key challenges and solutions in designing resilient and redundant systems within autologous cell therapy facilities and operations. We will discuss strategies for mitigating risks associated with process interruptions, technological failures, supply chain disruptions, and facilities design and maintenance. Through a case study of AstraZeneca's Rockville Manufacturing Center cell therapy facility, we will provide an overview of enhancing the reliability and stability of autologous cell therapy manufacturing. Our focus will be the design strategy of this facility and improving patient care and treatment availability by leveraging equipment and space redundancy, rolling shutdowns, strategic load shedding, and backup systems, ensuring 24/7/365 manufacturing in autologous cell therapy.
This presentation explores the key challenges and solutions in designing resilient and redundant systems within autologous cell therapy facilities and operations. We will discuss strategies for mitigating risks associated with process interruptions, technological failures, supply chain disruptions, and facilities design and maintenance. Through a case study of AstraZeneca's Rockville Manufacturing Center cell therapy facility, we will provide an overview of enhancing the reliability and stability of autologous cell therapy manufacturing. Our focus will be the design strategy of this facility and improving patient care and treatment availability by leveraging equipment and space redundancy, rolling shutdowns, strategic load shedding, and backup systems, ensuring 24/7/365 manufacturing in autologous cell therapy.
1045 – 1115
Regulations and Pharma 4.0
Norman Goldschmidt, Genesis AEC
ISO 14644-7 "Separative Devices" includes all types of equipment intended to separate a clean environment from a source of contaminants. The updated standard both greatly expands the range of equipment addressed by the standard, and also provides guidance for equipment that is critical in Aseptic Processing from unidirectional flow hoods to biological safety cabinets, to pass-through boxes, RABS and Isolators for containment and sterility. The revised standard provides practical guidance for specification and testing of separative devices that was missing in the prior version.
This presentation will give an overview of the upcoming changes to ISO 14644-7, which has been in process for 3 years.
This presentation will give an overview of the upcoming changes to ISO 14644-7, which has been in process for 3 years.
1115 – 1145
Sterility and Release
This presentation highlights the optimal method for room biodecontamination, with a particular focus on RABS (Restricted Access Barrier Systems). Traditionally, RABS are either manually surface decontaminated or treated with foggers while the room's ventilation is turned off. The VHP (Vaporized Hydrogen Peroxide) integrated technology enables a 6-log reduction in biological contaminants within the rooms and RABS, even with the doors closed and ventilation on. This approach ensures the integrity of the biodecontamination process while maximizing surface coverage and treating all filters effectively.
1115 – 1145
Regulations and Pharma 4.0
Aaron Mertens, STERIS Corporation | Life Sciences
Varadharaj Vijayakumar, Dr Reddys Laboratories Ltd
European Union EudraLex Volume 4 Annex 1 requires pharmaceutical manufacturers to establish a robust Contamination Control Strategy (CCS) that includes a set of controls for microorganisms, endotoxin/pyrogens, and particles to ensure process performance and product quality. It is especially critical to define the contamination risks and identify appropriate controls for critical surfaces, namely product contact parts that are cleaned, sterilized, and used in aseptic drug manufacture. This presentation highlights a case study where WuXi Biologics Germany upgraded the packaging necessary to protect product contact parts that are autoclave sterilized. While this upgrade was an improvement, the site CCS and change control committee required requalification of the autoclave process.
This presentation describes the attributes of the new packaging, the change control process, and the steps completed to implement the change.
Attendees will gain a better understanding of Annex 1 regulatory compliance, requirements for sterilization packaging, autoclave validation, and change control for aseptic drug manufacture.
This presentation describes the attributes of the new packaging, the change control process, and the steps completed to implement the change.
Attendees will gain a better understanding of Annex 1 regulatory compliance, requirements for sterilization packaging, autoclave validation, and change control for aseptic drug manufacture.
1115 – 1145
Advanced Therapy Medicinal Products
Speakers will address topics on the theme of the current state of the market in the ATMPs industry, the creative innovations used to decrease risk, time to market, and cost for the patients. Speakers will identify challenges faced in their experience and describe how they used creative solutions and approaches over decades in the advanced therapy space. They will speak from firsthand experience, describing how opportunities were created out of challenges that posed a threat to operations and, furthermore, providing lifesaving therapies to patients. These opportunities lie in manufacturing, quality control, and operational excellence, among other areas. Over the panelists' collective experience, numerous lessons were learned from a wealth of challenges. These lessons include, but are not limited to, robust and efficient technology transfer, early collaboration with R&D, operational readiness, and effective globalization, all while ensuring speed to market for therapies to save the lives of patients.
1145 – 1215
Sterility and Release
Geert Vandenbossche, PhD, C&E Solutions BV
The new Annex 1 revision requires sterilization of all surfaces that touch critical components, such as rubber stoppers and tip caps. Surface sanitizers are not suitable as they cannot reach under the silicon layer. The presentation will demonstrate 3 possible approaches to address this requirement, including the pilot for an integrated SIP unit surrounding a vibratory bowl and vibratory lanes:
1) Snap-on caps are caps with a recessed rubber stopper that clicks over the vial neck. They are more expensive than conventional stoppers and need line adaptation and container closure integrity assurance. Availability and capacity are limited.
2) Offline autoclaving of vibratory bowls and lines is another approach. Aseptic installation in the production lines is needed as demonstrated by APS and smoke studies. These items are bulky and installation can compromise aseptic practices. Protection by a cover or bag is needed if the autoclave is not connected to the grade A area. Installation can be done by hand, with assistance, or with automation/robotization.
3) In-situ SIP of critical component contact items: A promising solution is the in-situ steam in place (SIP) of the vibratory bowls and lines. This means steam sterilizing them in the production line. It is fast and simple, does not generate waste, and increases capacity. Existing lines can be upgraded, or new lines can include this feature from the design.
1) Snap-on caps are caps with a recessed rubber stopper that clicks over the vial neck. They are more expensive than conventional stoppers and need line adaptation and container closure integrity assurance. Availability and capacity are limited.
2) Offline autoclaving of vibratory bowls and lines is another approach. Aseptic installation in the production lines is needed as demonstrated by APS and smoke studies. These items are bulky and installation can compromise aseptic practices. Protection by a cover or bag is needed if the autoclave is not connected to the grade A area. Installation can be done by hand, with assistance, or with automation/robotization.
3) In-situ SIP of critical component contact items: A promising solution is the in-situ steam in place (SIP) of the vibratory bowls and lines. This means steam sterilizing them in the production line. It is fast and simple, does not generate waste, and increases capacity. Existing lines can be upgraded, or new lines can include this feature from the design.
1145 – 1215
Advanced Therapy Medicinal Products
Anthony Valle, Ultragenyx
Matthew Schmidt, Ultragenyx Pharmaceutical Inc
In the rapidly evolving field of Advanced Therapy Medicinal Products (ATMP), ensuring that patients receive timely and effective treatments is paramount. This presentation will explore implementing a "right first-time" (RFT) design approach in ATMP manufacturing. By focusing on precision and efficacy from the outset, RFT design minimizes errors and reduces the need for costly and time-consuming reworks. Our discussion will cover a recent project where this methodology was successfully applied to streamline production processes and accelerate delivery timelines.
Through a case study, we will illustrate how integrating RFT principles facilitated a seamless transition from development to manufacturing, ensuring that each step met stringent quality standards. The project harnessed advanced technologies and robust project management strategies to align production capabilities with patient needs swiftly and reliably. Attendees will gain insights into the practical application of RFT design, including its impact on operational efficiency, cost reduction, and patient outcomes. Join us to learn how adopting a "right first-time" approach in ATMP manufacturing can revolutionize production, meeting the urgent demands of patients while maintaining the highest standards of efficacy and safety.
Through a case study, we will illustrate how integrating RFT principles facilitated a seamless transition from development to manufacturing, ensuring that each step met stringent quality standards. The project harnessed advanced technologies and robust project management strategies to align production capabilities with patient needs swiftly and reliably. Attendees will gain insights into the practical application of RFT design, including its impact on operational efficiency, cost reduction, and patient outcomes. Join us to learn how adopting a "right first-time" approach in ATMP manufacturing can revolutionize production, meeting the urgent demands of patients while maintaining the highest standards of efficacy and safety.
1145 – 1215
Regulations and Pharma 4.0
Cathrine Friberg, Novo Nordisk
At Novo Nordisk we have developed and implemented a corporate QRM tool based on the Microsoft Power App platform to evaluate the effectiveness of a facility Contamination Control Strategy (CCS). We will present the QRM tool, the development process behind and how we revised the setup based on user input and lessons learned from internal audits and inspections. Finally, we present how we approach the CCS for greenfield projects.
The objective for this presentation is to present how Novo Nordisk managed to make a simple, yet comprehensive, approach to evaluate the effectiveness of contamination control for a facility, meeting the expectations in the revised EU Annex1 for Critical Control Points, Control Measures, and Monitoring Measures evaluation using QRM to drive continual improvement of the manufacturing and control methods.
The objective for this presentation is to present how Novo Nordisk managed to make a simple, yet comprehensive, approach to evaluate the effectiveness of contamination control for a facility, meeting the expectations in the revised EU Annex1 for Critical Control Points, Control Measures, and Monitoring Measures evaluation using QRM to drive continual improvement of the manufacturing and control methods.
1215 – 1330
Networking
1330 – 1400
Advanced Therapy Medicinal Products
Alexis Stachowski, Regeneron Pharmaceuticals, Inc.
James Polarine, Steris Corp.
This presentation will cover a contamination control strategy approach to pass through decon of critical items into cleanrooms, airlocks, biological safety cabinets (BSCs), Isolators, and RABS. There will be a focus on how to proactively prevent contamination from fungal and bacterial spores and other microorganisms including viruses, bacteria, yeasts, and phage. A recent fungal spore case study from the past few months in an ATMP cleanroom facility will be discussed in relation to incubators and pass-through decon. Published data will also be highlighted to convey effective methods for controlling and testing bioburden in the cleanrooms, RABS, Isolators, and BSCs. This presentation well be a complete holistic approach to controlling bioburden from entering cleanrooms and BSCs.
1330 – 1400
Filling Operations
David Phasey, 3P Innovation
Jixing Wang, Dalton Pharma Services
Dalton Pharma Services required a state-of-the-art Robotic filling line that can aseptically dose challenging powders into a wide variety of container formats.
There are more and more powders and engineered particles being developed for parenteral applications that cannot be terminally sterilized. Often driven by the need to improve drug stability during distribution to patient, this is a growing sector of the market that is significantly under served from a technology perspective.
While the automated handling of container formats can be easily replicated by the liquid solutions, the real challenges lie in the handling, feeding and dosing of the powder drug product.
This case study will demonstrate how to overcome the challenges of dosing poor flowing powders in aseptic conditions. Key challenges the solution had to overcome included particulate monitoring in a dust generating environment and how to continually introduce powder into the grade A fill chamber. The end result was a solution that is capable of handling multiple RTU container formats and improved the output from 45 vials an hour to 300 an hour. This made a number of products a lot more commercially viable and hopefully opens the door to more sterile powders reaching the market.
There are more and more powders and engineered particles being developed for parenteral applications that cannot be terminally sterilized. Often driven by the need to improve drug stability during distribution to patient, this is a growing sector of the market that is significantly under served from a technology perspective.
While the automated handling of container formats can be easily replicated by the liquid solutions, the real challenges lie in the handling, feeding and dosing of the powder drug product.
This case study will demonstrate how to overcome the challenges of dosing poor flowing powders in aseptic conditions. Key challenges the solution had to overcome included particulate monitoring in a dust generating environment and how to continually introduce powder into the grade A fill chamber. The end result was a solution that is capable of handling multiple RTU container formats and improved the output from 45 vials an hour to 300 an hour. This made a number of products a lot more commercially viable and hopefully opens the door to more sterile powders reaching the market.
1330 – 1400
Advanced Modalities
The field of radiopharmaceuticals and targeted therapies is rapidly evolving, driving a critical need for state-of-the-art production facilities. These facilities must navigate the unique convergence of Food and Drug Administration (FDA) and Nuclear Regulatory Commission (NRC) regulations to ensure product safety, efficacy, and compliance with the increasing demand for precision medicine. The importance of advanced radiopharmaceuticals is growing, necessitating cutting-edge design solutions. We will delve into the latest trends and innovations in radiopharmaceuticals, highlighting their impact on the industry.
This presentation will explore the essential design elements of radiopharmaceutical production facilities emphasizing safety, containment, sterilization, and HVAC systems to maintain sterility and prevent contamination. Technical solutions such as hot cells, isolator technology, automated sterilization processes, containment filtration system, and high-efficiency particulate air (HEPA) filtration will be discussed, showcasing their roles in achieving compliance with stringent regulatory standards. Case studies with technical solutions developed for the most common radioisotopes will be presented. Attendees will gain valuable insights into the technical and operational challenges of facility design, providing a comprehensive understanding of the measures required to support these targeted therapies.
1400 – 1430
Advanced Therapy Medicinal Products
Luis Tirado-Maldonado, Takeda Pharmaceuticals Company
Isolators are a proven barrier technology for aseptic processing and are the preferred option for many to eliminate direct human interaction with the product. Adapting isolators for cell therapies is possible, although CT processes are very manual in nature, and often subject to time limits and other constraints. Once you identify process limitations such as this, one is able to model the manufacturing process, identifying natural pause points for use in introducing additional components inside the chamber and removing waste containers or materials. It should be noted that operations utilizing an Isolator don't represent a 'Get Out of Jail Free Card' that allows less stringent aseptic practices. One must find the proper balance between the advantages and constraints inherent in the use of the technology. Isolators can give you assurance that your product is safe and sterile, and you will be able to demonstrate this during inspections. For all of us, the Patient should be our primary concern, and a barrier system can grant you advantages in meeting their needs for high-quality products.
1400 – 1430
Filling Operations
Mary Van Gaasbeck, Steris Corporation
Personalized medicine is an evolving field, offering targeted solutions that benefit patients by minimizing side effects and increasing effectiveness. This introduces a need for specialized fill-finish equipment that can efficiently route product into final packaging in an aseptic manner. Parenteral medications are often packaged in one of two forms: an aqueous solution or a dry powder that is dissolved in a solvent prior to administration.
While both forms present unique challenges, powder products are particularly difficult to fill in an aseptic environment. One of the key requirements for a Grade A level (ISO5) environment is low particulates. Handling a powder product, which inherently generates particulates, requires precise control. This case study examines how Evonik, a leading global contract development and manufacturing organization (CDMO), improved its powder transfer process for parenteral drug products without compromising efficiency or safety.
This abstract explores the need for specialized fill-finish equipment in the aseptic manufacturing environment. A method for parenteral powder handling is examined in detail at a global CDMO facility. This case study examines how Evonik, a leading global contract development and manufacturing organization (CDMO), improved its powder transfer process for parenteral drug products without compromising efficiency or safety.
While both forms present unique challenges, powder products are particularly difficult to fill in an aseptic environment. One of the key requirements for a Grade A level (ISO5) environment is low particulates. Handling a powder product, which inherently generates particulates, requires precise control. This case study examines how Evonik, a leading global contract development and manufacturing organization (CDMO), improved its powder transfer process for parenteral drug products without compromising efficiency or safety.
This abstract explores the need for specialized fill-finish equipment in the aseptic manufacturing environment. A method for parenteral powder handling is examined in detail at a global CDMO facility. This case study examines how Evonik, a leading global contract development and manufacturing organization (CDMO), improved its powder transfer process for parenteral drug products without compromising efficiency or safety.
1400 – 1430
Advanced Modalities
Gary Perkins, Nucleus RadioPharma
The presentation will open with an overview of the current landscape for the rapidly growing radiopharmaceutical market. Important to this market is being able to balance safety practices, aseptic operations, and manufacturing workflows. Just-in-time (JIT) manufacturing has revolutionized production processes, emphasizing efficiency, cost-effectiveness, and reduced waste. However, the integration of JIT principles presents unique challenges in maintaining stringent radiation safety standards, essential for the production of radiopharmaceuticals and other radiation-based treatments. This presentation explores the development and implementation of robust radiation safety practices tailored to JIT manufacturing environments. Key topics include real-time monitoring systems, advanced training programs for personnel, and adaptive safety protocols that ensure compliance without compromising the agility of JIT workflows. Attendees will gain insights into best practices for mitigating radiation risks, optimizing resource allocation, and enhancing overall safety culture in JIT settings. This session is important for professionals seeking to align radiation safety with the dynamic demands of pharmaceutical manufacturing.
1430 – 1500
Advanced Therapy Medicinal Products
We aim to provide collected experience and suggestions for best practice on how existing and future digital ecosystems can be used to optimize aseptic manufacturing in ATMP by focusing on existing software functionalities, data flow, and data analysis.
The presentation aims to answer how digitization can support aseptic manufacturing in ATMP applications, including:
Specific challenges in ATMP in terms of aseptic manufacturing
How to avoid batch cross contamination > traceability and batch separation by digital solutions (including Summary of BioPhorum publication on patient/donor traceability, compartmentation in automated systems, current role of MES and PCS in the ATMP landscape to coordinate the unit operations, line clearance using digital solutions, and material traceability).
How to avoid contamination > support and integration of environment monitoring and alarm controls.
Sterility analysis > speed up release process (such as aseptic process optimization, including data management and holistic process models, data lake concepts for ATMP, digital twin applications for aseptic ATMP manufacturing, real time analysis in individual manufacturing units spanning over several equipment items, and automatic decisions on level 2 and level 3 for ATMPs.)
AI applications such as self learning risk analysis model for questions above, optimization questions, and classification according to the ISPE AI guidelines.
The presentation aims to answer how digitization can support aseptic manufacturing in ATMP applications, including:
Specific challenges in ATMP in terms of aseptic manufacturing
How to avoid batch cross contamination > traceability and batch separation by digital solutions (including Summary of BioPhorum publication on patient/donor traceability, compartmentation in automated systems, current role of MES and PCS in the ATMP landscape to coordinate the unit operations, line clearance using digital solutions, and material traceability).
How to avoid contamination > support and integration of environment monitoring and alarm controls.
Sterility analysis > speed up release process (such as aseptic process optimization, including data management and holistic process models, data lake concepts for ATMP, digital twin applications for aseptic ATMP manufacturing, real time analysis in individual manufacturing units spanning over several equipment items, and automatic decisions on level 2 and level 3 for ATMPs.)
AI applications such as self learning risk analysis model for questions above, optimization questions, and classification according to the ISPE AI guidelines.
1430 – 1500
Filling Operations
Aidan Harrington, PhD, Arcadis
The European ban on PFAS substances, the supply constraints of Cobalt-60 for gamma irradiation, and the reality that particles will likely be present as technically unavoidable particles in complex systems are all considerations that must be addressed to enable the implementation and continued use of SUS applications. For all three scenarios above, the desired outcomes leading to undisrupted ongoing use are and will continue to be underpinned by proactive engagement between the pharmaceutical industry, SUS suppliers, and regulators. While the presentation will provide some background to the above, the focus will be on the current efforts, both ongoing and needed by stakeholders, to enable both the supply and continued use of SUS.
1. The transition from gamma irradiation to x-ray will be addressed bearing in mind the outcomes of industry and EMA / FDA / PMDA engagements and further regulatory enablers required to support this transition.
2. Annex 1 highlighted some specific risks associated with SUS, one being the risk of particle contamination.
3. Systems assembled by suppliers from multiple components and material types, manufactured by multiple suppliers, present PFAS-related integrity & particle challenges. Collaboration and innovation with the SUS supplier, in addition to robust in house controls, will mitigate associated risks.
1. The transition from gamma irradiation to x-ray will be addressed bearing in mind the outcomes of industry and EMA / FDA / PMDA engagements and further regulatory enablers required to support this transition.
2. Annex 1 highlighted some specific risks associated with SUS, one being the risk of particle contamination.
3. Systems assembled by suppliers from multiple components and material types, manufactured by multiple suppliers, present PFAS-related integrity & particle challenges. Collaboration and innovation with the SUS supplier, in addition to robust in house controls, will mitigate associated risks.
1430 – 1500
Advanced Modalities
The presentation aims to establish key aspects of the specific field of radiopharmaceutical production - likely unknown to the audience - to shape a future regulatory landscape where its diverging features contribute to defining actionable boundaries and an inclusive landscape.
The second aim is to facilitate the contextual interpretation and compliant process design in consideration of the new Annex 1.
The second aim is to facilitate the contextual interpretation and compliant process design in consideration of the new Annex 1.
1500 – 1515
1515 – 1545
General Session
Yolanda McLean, Alnylam Pharmaceuticals
Women in Pharma® Supported Presentation—Humanizing Audits: The Role of Leadership, Emotional Intelligence, and Team Dynamics in Compliance
In this 30-minute keynote, Yolanda McLean will explore how leadership, emotional intelligence, and team dynamics can transform the audit experience. Focusing on the human aspect of regulatory interactions, this session will delve into the importance of trust-building, clear communication, and fostering team confidence to create more effective and collaborative audits.
Designed for leaders, compliance professionals, and those looking to enhance their influence, this keynote will highlight how emotional intelligence can help navigate challenging audit scenarios, build stronger teams, and ensure successful outcomes. The presentation will conclude with key takeaways on behaviors that foster cooperation with regulators and reinforce compliance, leaving attendees equipped with practical strategies for elevating their audit interactions.
In this 30-minute keynote, Yolanda McLean will explore how leadership, emotional intelligence, and team dynamics can transform the audit experience. Focusing on the human aspect of regulatory interactions, this session will delve into the importance of trust-building, clear communication, and fostering team confidence to create more effective and collaborative audits.
Designed for leaders, compliance professionals, and those looking to enhance their influence, this keynote will highlight how emotional intelligence can help navigate challenging audit scenarios, build stronger teams, and ensure successful outcomes. The presentation will conclude with key takeaways on behaviors that foster cooperation with regulators and reinforce compliance, leaving attendees equipped with practical strategies for elevating their audit interactions.
1545 – 1700
The 2025 ISPE Aseptic Conference Regulatory Panel will focus on pharmaceutical-technical aspects of the manufacturing of sterile products, including the interpretation of the relevant guidelines like Annex 1 and recent inspection learnings. In addition to the moderated discussion, there will also be the possibility for the audience to ask live questions. This interactive panel is always a much anticipated and informative session, providing insights exclusively to conference attendees.
Speaker Qualifications
Speakers selected to present at ISPE events are leading professionals in their fields. However, it may be necessary to make substitutions. Every possible effort will be made to substitute a speaker with comparable qualifications. Every precaution is taken to ensure accuracy. ISPE does not assume responsibility for information distributed or contained in these events, or for any opinion expressed.
Agenda Changes
Agenda is subject to change. Last minute changes due to functional, private, or organizational needs may be necessary. The event organizer accepts no liability for any additional costs caused by a change of the agenda.