Agenda

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Technical PresentationLive-streamed education sessions.

Day 1
Monday, 14 March 2022
  • 0900 - 1030
    Opening Plenary Session
    Session Leaders

    Jörg Zimmermann

    Vice President, Vetter Development Service, External Affairs
    Vetter Pharma-Fertigung GmbH & Co.
    Speakers
  • 0920 - 0955
    Harmonization Efforts of PIC/S and the Impact on Aseptic Processing
    Speakers

    Paul A. Gustafson

    2022 PIC/S Chair, Senior Corporate Regulatory Compliance & Enforcement Advisor
    Regulatory Operations and Regions Branch (RORB), Health Canada
  • 0955 - 1025
    Emerging Guidance for Aseptic Processing - FDA Perspective
    Speakers

    Alonza Cruse

    Director, Office of Pharmaceutical Quality Operations
    FDA/ORA
  • 1030 - 1115
    Networking Break in Exhibit Hall
  • 1115 - 1230
    Design & Development of Components in Aseptic Manufacturing
    In this session, two critical types of materials for aseptic processing are covered: pre-sterilized components (syringes, vials, stoppers, etc.) and single-use components (filters, tubing, assemblies). You will gain an understanding of how to design, develop, and implement components in your manufacturing processes. The presentations look at leveraging single-use technology alongside an agile risk management program and how to build resiliency into disposable systems. What is required to redesigning pre-sterilized components, and how to ensure their comparable sustainability and sterility? After this session, participants will have a better understanding how to build a foundation to strengthen the business operations, including regulatory/quality compliance, operational excellence of the supply chain suppliers, and development of robust technical due diligence controls.
    Session Leaders

    Jörg Zimmermann

    Vice President, Vetter Development Service, External Affairs
    Vetter Pharma-Fertigung GmbH & Co.
  • 1115 - 1230
    Robotics and Implementation of New Strategies

    The session focuses on robotics for creating a new facility and implementation of new strategies and methods for process monitoring. Case studies include presentations from Takeda and Cilag (Jansen). Participants will get an understanding of:

          
    • How to use robotics to design a facility for the future on aseptic manufacturing. This includes fill and finish, but also the supporting areas, automated transfers between cleanroom classes, line set up, the cleaning of the rooms, and fully automated lab
    •     
    • Advanced analytical technologies and digital tools for continuous environmental monitoring strategy. including Quality Risk Management (QRM) and Contamination Control Strategies (CCS) to use continuous monitoring, qualification and validation requirements, acceptance criteria as well as the needed design criteria for a Continuous viable particle monitoring strategy.
    Session Leaders
  • 1120 - 1145
    Redesigning Ready to Use Components
    Speakers

    Sven Filler

    Strategic Investment Program Director
    Bayer AG
    Presentation Information
    [Redesigning Ready to Use Components]
    Speakers: Svenja Michaela Gutsche and Sven Filler
    This presentation will review the outcomes of the Workshop on how to redesign Ready to Use Components like Tubs for nested Sytringes to be more sustainable and easy to use for robotic applications. RTU Componets are ofthe used in Aseptic Manufacturing but are they sustainable, do they provide sterility etc.>br/>
  • 1120 - 1145
    Facility of the Future on Robotics in Aseptic Manufacturing
    Speakers

    Julien Janda

    Head of Process & Technology, GMS Global Engineering
    Takeda Pharmaceutical International AG
    Presentation Information
    [Facility of the Future on Robotics in Aseptic Manufacturing]
    Speaker: Julien Janda
    The Special Interest Group SIG Future Robotics of the ISPE DACH was founded in 2019. The group is working on different workstreams for the future of Robotics Manufacturing in the pharmaceutical industry. How such a Facility for the Future on Aseptic Manufacturing could be design would be part of the presentation. The presentation will cover the fill and finish part, but also the supporting areas, automated transfers between cleanroom classes, line set up, the cleaning of the rooms, fully automated lab, etc. All those topics do have its own task team in the ISPE DACH SIG Future Robotics and case studies of the current developments are shown in the presentation.
  • 1145 - 1210
    Building Resiliency into Single-Use-Technology Systems
    Speakers
    Placeholder Person Graphic

    Kara Vogt

    Process Engineer, Technical Services
    INCOG BioPharma Services
    Presentation Information
    [Building Resiliency into Single-Use-Technology Systems]
    Speakers: Jo Ann Jacobs and Kara Vogt
    The COVID-19 pandemic pressured biomanufacturers to wait extraordinarily long periods for single-use bioprocess systems and materials. Although these systems have become standard in the industry, the shift to these disposable systems has highlighted how important it is to have redundancy in the necessary tools used in the development and commercial manufacturing of vaccines and therapies. The INCOG BioPharma team will discuss how they have weighed the risks highlighted by the pandemic and how they have developed other ways to build resiliency into using single use systems, suppliers, and other backup means as they prepare to launch in 2022.
  • 1145 - 1210
    A Step to Human-less Aseptic Operation - Continuous Environmental Monitoring Strategy
    Speakers
    Presentation Information
    [A Step to Human-less Aseptic Operation - Continuous Environmental Monitoring Strategy]
    Speakers: Ruth Barenstein and Thomas Thurn
    Modern isolator technology together with Robotics has been consistently reported in the literature to reliably provide a safe environment for aseptic filling. Nevertheless, conventional monitoring approaches originally developed for manned cleanrooms are still applied. Given that monitoring with agar plates has its own limitations regarding the sensitivity of the method and by limited volumes of air sampled, it poses a risk for the drug product itself by the interventions and handling steps connected to sampling, transport and evaluation. The presentation will focus on a Continuous Viable Particle Monitoring Strategy and cover the following topics. Quality Risk Management QRM and Contamination Control Strategies CCS to use Continuous Monitoring, Qualification and Validation Requirements, Acceptance Criteria as well as the needed Design Criteria for a Continuous Viable Particle Monitoring Strategy.
  • 1230 - 1330
    Lunch in the Exhibit Hall
  • 1330 - 1445
    Robotics and Implementation of New Strategies 2
    Get insights about both realized solutions and upcoming innovations that are implemented into Isolator lines and simplify all phases of the typical fill-finish manufacturing lifecycle. The presentations will provide better insight into the benefits of gloveless, robotic isolators, and advantages from the resulting risk reductions.
    Session Leaders
  • 1330 - 1445
    Implementing and Ensuring Robust Contamination Control
    This session will focus on contamination control strategies including best practices for design, implementation, and risk management with a focus on Annex 1 and process modeling. Our first presenter will discuss the best practices for building a contamination control strategy while maintaining quality throughout the lifetime of the system. Our second speaker will present a case study involving a pilot project related to sterile manufacturing with the objective of implementing a control system using real time elements to support enhanced control strategy.
    Session Leaders

    Dina Manfredi

    Director of Sales and Business Development
    GMP Systems Inc
  • 1335 - 1400
    Contamination Control, Risk and the Quality Management System
    Speakers
    Presentation Information
    [Contamination Control, Risk and the Quality Management System]
    Speaker: Jeremiah Genest
    Contamination Control is a fairly wide term used to mean “getting microbiologists out of the lab” and involved in risk management and the quality management system. This presentation will evaluate best practices in building a contamination control strategy and ensuring its use throughout the quality system. Leveraging a House of Quality approach, participants will learn how to: Create targeted/ risk based measures of contamination avoidance; Implement Key performance indicators to assess status of contamination control; and ensure a defined strategy for deviation management (investigations), CAPA and change management.
  • 1335 - 1400
    Production Data from Standard Robotic Filling Workcells
    Speakers
    Presentation Information
    [Production Data from Standard Robotic Filling Workcells]
    Speakers: Joseph McCall, Jr. and Kevin Gadient
    Robotic and isolator technologies have fundamentally changed the risk profile of aseptic filling processes. Regulatory agencies, including USFDA and Health Canada, have approved these technologies for commercial products. The application of robotics and gloveless isolators, combined with a standardized design, have advanced contamination control to the point where some of the most significant remaining risk is the use of conventional EM programs. Forcing a conventional EM program to fit an advanced aseptic processing system may increase risk and provide no scientifically supportable benefit. To maintain the significant advantages achieved in contamination control with these new technologies, a different perspective is needed to identify suitable monitoring strategies. In this presentation, production data from a number of participating companies will be reviewed: airborne particle data, viable microbial monitoring, media fills, particulates in drug product, and comparisons of room monitoring to the microbial load of the isolator in idle state. Additionally, images from computational fluid dynamic studies will show airflow and particle trajectories within the isolator.
  • 1400 - 1425
    Retrofit of Innovative Robotic Solutions into Existing Production Lines
    Speakers
    Presentation Information
    [Retrofit of Innovative Robotic Solutions into Existing Production Lines]
    Speakers: Marko Hahn and Daniel Sturm
    A case study and best practice demonstration on how to retrofit innovative robotic solutions into a legacy line in order to eliminate multiple manual tasks previously executed by an operator.
  • 1405 - 1425
    Real Time Control Elements and Process Modelling
    Speakers
    Presentation Information
    [Real-Time Control Elements and Process Modelling]
    Speaker: Lorenz Liesum and Tobias Ladner
    Within the manufacturing world of solid dosage forms, many applications have been implemented in recent years using advanced analytical technologies and digital tools for supporting an enhanced control strategy. In this paper we will present a pilot project related to sterile manufacturing with the objective to implement a control system using real time elements and making use of predictive multivariate models for process monitoring of different aseptic unit operations. The presentation will elaborate on the difference of these models compared to known use cases for DS manufacturing of biotech products. This pilot is a product driven approach for the introduction of new analytical technologies covering physico-chemical assays as well as rapid microbiological assessments with the overall intention to simplify the release process and reduce the overall release lead time.
  • 1445 - 1530
    Networking Break in the Exhibit Hall
  • 1530 - 1655
    Industry Panel: Overcoming the Biggest Challenges in C+G/ATMPs

    Over the last few years, there has been enormous growth in the ATMP market, largely in part to world-class research institutions, an abundance of life science talent, a remarkable transportation infrastructure including cold chain supply, immense square footage of lab space, and world-class hospital systems. However, none of these moving parts could be possible without life science companies realizing their “aha moment” that collaboration and innovation were necessary to achieve the end goal – to lead the world in delivering therapies to patients. Experts from leading life sciences companies will discuss the importance of collaboration to overcome current issues facing the industry, specifically, talent, know-how, equipment, consumables necessary to run GMP processes, and access to development and manufacturing capacity. Please join us for this lively panel discussion centered around trends and challenges facing the overall ATMP industry and the novel strategies that each company is implementing to overcome these obstacles.
    Session Leaders

    Alexander Haig

    Vice President, Engineering
    INCOG BioPharma Services, Inc.
    Speakers

    Mario Miele

    Vice President Facilities and Engineering
    ElevateBio

    Matthew H. Snyder

    Associate Director, Engineering & Facilities
    Center for Breakthrough Medicines

    Richard Denk

    Senior Consultant Aseptic Processing & Containment
    SKAN AG

    Sumit Verma

    Senior Vice President, Commercial Manufacturing
    Iovance Biotherapeutics, Inc.
  • 1655 - 1700
    Closing Remarks
  • 1700 - 1800
    Welcome Reception in the Exhibit Hall
Day 2
Tuesday, 15 March 2022
  • 0730 - 0855
    Breakfast - Barrier Survey: Impacts from a Changed World and New Therapies

    Sponsored by Women in Pharma® How has a global pandemic, focus on new therapies, and more, changed the trends in applications of barrier technology and their implementation? Women in Pharma® is pleased to host this important technical session. Attendees will hear about the latest trends in aseptic processing within barrier technology and have the opportunity to voice types of solutions requiring more attention. Members of the Barrier Survey Team will provide an overview of the more notable results and topics first revealed at the 2020 ISPE Aseptic Conference and in the 2020 Barrier Survey article published in August 2020 Pharmaceutical Engineering. During an interactive portion, the panel will invite attendees to collaborate, and voice needed areas of technological development and project execution that would positively impact Aseptic Filling applications. This session will inform as well as offer the chance for attendees to help fulfill ISPE's vision of addressing challenges through innovation and collaboration
    Speakers

    Elizabeth J. Dorn

    Aseptic Filling SME - Representing Owners Interests in Capital Projects
    EliRx

    Paul F. Valerio

    Director of Process Technology / Senior Associate
    IPS - Integrated Project Services, LLC
  • 0845 - 0900
    Break
  • 0900 - 0945
    Microbiological Quality and Cultivating Emerging Leaders
    Sterility Assurance practices will need to pivot with a focus on the Microbiological Quality of future products.  This means that the sterility assurance community may need to think differently with new innovative products and how we deliver microbiological quality.  In addition, the development of new emerging leaders needs to continue to be a priority for the technical community.  The industry must focus on providing these leaders with key experiences – both technical and management – to develop the competencies needed to support innovations.  The first part of this presentation will share information on what product microbiological quality means and future changes, and the second part of this presentation will focus on cultivating emerging leaders.
    Session Leaders

    Jörg Zimmermann

    Vice President, Vetter Development Service, External Affairs
    Vetter Pharma-Fertigung GmbH & Co.
    Speakers

    Joyce M. Hansen

    Vice President of J&J Microbiological Quality and Sterility Assurance
    Johnson & Johnson
  • 0945 - 1000
    Question and Answer/Discussion
  • 1000 - 1045
    Networking Break in the Exhibit Hall
  • 1045 - 1200
    Enzyme H2O2-Indicators in Aseptic Production Environment
    The H2O2-session shall inspect the possibilities and limitations of their emerging technology of H2O2 indicators. The attendees will learn how the universal normalization approach enables comparison of results independently from day or system dependent influences. This may offer a better way to quantify the VPHP cycle, allowing for better cycle design, control, and understanding. More data leads to improved confidence while opening opportunities in some systems to leverage data for continuous validation models by removing the need for re-qualification entirely.
    Session Leaders
  • 1045 - 1200
    Process Development & Manufacturing for Highly Potent Subs|

    The highly potent substance session will focus on the control strategies for HPAPI production, addressing the following topics:
    1. The best-practice cases for cross-contamination control strategies
    2. How to apply QRM principles according to latest GMP regulations and industry guidance
    3. Strategies for risk control of cross-contamination in an existing F&F facility
    4. How to address PDE/ADE and OEL together with Aseptic Production and Bio Safety levels expectations and regulations
    5. Identifying the best restricted access barriers and adopting them with the existing Bio Safety and Worker Safety

    Session Leaders

    Richard Denk

    Senior Consultant Aseptic Processing & Containment
    SKAN AG
  • 1045 - 1200
    Projects during the Pandemic--Technical and Process Case Studies

    Come and learn how pharmaceutical companies have responded to the recent operational impediments. Two case studies will be highlighting the challenges of project execution last year, and how their firms overcame them. One study will examine the Process Performance Qualification of COVID-19 vaccine production and the other will delve into upgrading aseptic filling facilities while minimizing the impact to production.
    Session Leaders
  • 1050 - 1110
    HPAPI Product and Containment Strategies
    Speakers
    Presentation Information
    [The Implementation of Robotic Fill & Finish at a German CDMO]
    Speakers: Bianca Bohrer and Thorsten Haefner
    There is an increasing demand for C(D)MO capabilities globally for aseptic and aseptic toxic drug fill&finish for small and mid size batches. PSM GmbH has expanded its capabilities in this area from analytics, drug development through final fill&finish with latest fill&finish technologies: The focus is to offer technologies that meet already today the latest EU Gmp Annex 1 requirements and set a new market trend: The use of gloveless filling equipment, using robotics in a smart and intelligent way to remove operators from the aseptic area and to assure a holistic contamination control strategy for highest sterility assurance. The presentation will show the journey of the implementation of new technologies according the new Annex 1 in a cooperation between industry, regulatory authorities and suppliers and will also include an overview how sterile filtration must be setup to ensure a PUPSIT can be executed proberly in combination with a gloveless robotic fill & finish technology.
  • 1050 - 1110
    Evaluation of Enzyme Indicators for H2O2 Decontamination
    Speakers
    Presentation Information
    [Evaluation of Enzyme Indicators for H2O2 Decontamination]
    Speaker: Andreas Demmler
    The application of biological indicators (Geobacillus stearothermophilus) for development and validation of H2O2 biodecontamination cycles for barrier systems is common across the industry. However, these indicators inherit certain drawbacks like significant variability together with necessary incubation times. Over the last years, a new type of indicator became available that should overcome the drawbacks. These new indicators use the decomposition of an enzyme (thermostable adenylate kinase, tAK) by H2O2. So far, there is no broad experience on the practical application of these enzyme indicators in industry. In this presentation a comprehensive evaluation of the new indicators on a scientific basis will be given. Based on the results of investigations that were also published recently, the variability and significance of indicator response will be discussed. The application of a universal normalization approach enables comparison of results independently from day or system dependent influences. Further, the correlation between enzyme indicator response and microbiological indicators is evaluated. In this way, the presentation will make you familiar with this new emerging technology and give you an idea about the possibilities and limitations of the new indicators. Finally, suggestions on potential use in practical application are given as a basis for individual evaluation.
  • 1050 - 1110
    Pre-PPQ Vaccine Lots - They Weren't So Crazy After All
    Speakers
    Presentation Information
    [Pre-PPQ Vaccine Lots - They Weren't So Crazy After All]
    Speaker: Andrew Spasoff
    Normally, any lot manufactured prior to the start PPQ, could not be used for commercial distribution. Since the COVID-19 pandemic was not normal, we developed a novel approach to overcome the challenges of short development and tech transfer timelines to speed safe and efficacious vaccine doses to patients. The presentation will discuss compliance, GMP and regulatory considerations that were fundamental to the success of this approach. As a result of this presentation participants will better understand some of the vaccine commercialization challenges AZ faced, specifics about what regulators around the globe thought of this idea and the ideas on how this agile CMC approach could have broader applicability.
  • 1105 - 1125
    Enzyme Indicators for Quantifying VPHP Exposure
    Speakers
    Presentation Information
    [Enzyme Indicators for Quantifying VPHP Exposure]
    Speaker: Richard Panton
    Using Enzyme Indicators in place of Biologic Indicators during cycle development to reduce testing duration, and increase information fidelity. Using EI data, engineering solutions can be implemented, system parameters can be quickly adapted and tested, and risks to traditional system qualification can be better understood.
  • 1110 - 1130
    Manufacturing of High Potent Substances
    Speakers

    Reinhold Maeck, PhD

    Head of Corp EHS Regulatory Intelligence
    Boehringer Ingelheim Corporate Center GmbH
    Presentation Information
    [Manufacturing of High Potent Substances in Aseptic Manufacturing]
    Speaker: Reinhold Maeck
    Novel new therapies like ATMPs (Cell and Gene), ADCs (Antibody Drug Conjugates) or new generation for vaccines are considered as highly potent or require a higher Bio Safety Level. For some of the products requirements for GMP and Occupational Safety are set. How to ensure that PDE/ADE (Permitted Daily Exposure/Accepted Daily Exposure) and OEL (Occupational Exposure Level) can be ensured taking also Aseptic Production and Bios Safety levels into account. Aseptic manufacturing using Barrier Systems like Isolators are considered to operate in positive pressure for GMP reason, how to best adopt these aspect with Bio Safety and Worker Safety expectations and regulations. The presentation will focus on the GMP Requirements for Contamination and Cross Contamination Control for high potent products as well as for products with a required Bio Safety Level.
  • 1110 - 1130
    Restricted Access Barrier System Retro-fit Case Study
    Speakers
    Presentation Information
    [Restricted Access Barrier System Retro-fit Case Study]
    Speakers: Leslie M. Edwards and Brian Smith
    Novo Nordisk / SKAN case study reflects how an active facility can upgrade existing aseptic cartridge filling lines with minimal impact to production schedules. Both companies developed innovative solutions by combining their regulatory expertise, process, equipment knowledge, creativity to design compliant upgrades for the future and to ensure higher sterility assurance levels. SKAN engineered and installed (3) RABS Retro-fits to the existing Novo Nordisk productions line. Each line was a different layout with different features that required different solutions. Their combined experience in aseptic manufacturing, current and new Aseptic Guidelines allowed them to design unique features on each line. The key to successful retro-fits like this is the understanding of how the equipment functions, how the equipment can be altered/improved, how the existing aseptic process works and what can be improved. During the design phase, the teams took great c are in understanding the ergonomics and the airflow within the room and Barrier/RABS. This was all accomplished with minimal down time.
  • 1200 - 1300
    Lunch in the Exhibit Hall
  • 1315 - 1445
    Aseptic Group Discussions: Annex 1 Implementation: Challenges and Opportunities
    The first publication of Annex 1 can be traced back to 1971 where it then described the foundational elements to ensure sterility of commercialized medicinal products.    Since that time Annex 1 has undergone a number of targeted updates but only recently has undergone a full review.  After two rounds of targeted consultation, with the most recent being completed July 2020, industry now waits for the final publication which is anticipated mid 2022.    The Annex 1 revision has far-reaching implications for many years to come.  This breakout session will afford the opportunity to share both the challenges and opportunities faced with implementation.  Potential areas of discussion related to Inspection approaches/experiences as well as the application of QRM principles will be explored.
    Session Leaders
  • 1315 - 1445
    Barrier Group Discussions: Optimizing Your Bio Decontamination Cycle Utilizes Enzyme Indicators
    A discussion group of industry experts will be on hand to discuss how to optimize vaporize/ionized/fogged hydrogen peroxide cycle utilizing enzyme indicators. Panel will discuss technical aspects, operability, detection, regulatory expectation including the latest research. Join operations and equipment specialists to understand how this technology can streamline you’re approach and timeline.
    Session Leaders
  • 1315 - 1445
    Containment Group Discussions: Biosafety and Cleaning
    New therapies such as cell and gene therapy require higher biosafety level during manufacturing. In this breakout various questions concerning containment and cleaning will be discussed. - How to prepare a manufacturing suite for e.g., BSL 2 product? - What are the GMP requirements for cross-contamination, and how to protect the operators during production?  - How to prevent contamination but also cross-contamination and what is the right cleaning method and how to quantify clean in aseptic processing?
    Session Leaders

    Richard Denk

    Senior Consultant Aseptic Processing & Containment
    SKAN AG
  • 1445 - 1530
    Networking Break in the Exhibit Hall
  • 1530 - 1650
    Interactive Regulatory Panel
    Session Leaders
    Speakers

    Paul A. Gustafson

    2022 PIC/S Chair, Senior Corporate Regulatory Compliance & Enforcement Advisor
    Regulatory Operations and Regions Branch (RORB), Health Canada

    Rick Friedman

    Deputy Director, Office of Manufacturing Quality
    CDER/FDA

    Brooke Higgins

    Senior Policy Advisor for the Global Compliance Branch 3
    FDA

    Alonza Cruse

    Director, Office of Pharmaceutical Quality Operations
    FDA/ORA
  • 1650 - 1700
    Closing Remarks