Agenda
Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
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
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.
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.
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 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 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).
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.
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.
- Material preparation
- Entry procedure
- Decontamination
- Transfer to isolator
- Final preparation
- Environmental monitoring
- Validation
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.
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.
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 will give an overview of the upcoming changes to ISO 14644-7, which has been in process for 3 years.
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.
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.
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.
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.
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.
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.
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.
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.
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.
The second aim is to facilitate the contextual interpretation and compliant process design in consideration of the new Annex 1.
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.
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.