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Opening Plenary Session
09:00am - 10:30am Eastern - March 14, 2022
Joerg Zimmermann, Vetter Pharma-Fertigung GmbH & Co., Vice President, Vetter Development Service, External Affairs; Thomas B. Hartman, President and CEO, ISPE; Paul A. Gustafson, 2022 PIC/S Chair, Sr. Corporate Regulatory Compliance & Enforcement Advisor, Regulatory Operations and Enforcement Branch (ROEB), Health Canada; Michael G. Higgins, Senior Compliance Advisor, Roche/Genentech; Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, FDA/ORA

Opening Plenary


Monday
Opening Remarks
09:00am - 09:10am Eastern - March 14, 2022
Thomas B. Hartman, President and CEO, ISPE

Monday
Welcome and Introduction to PIC/S
09:10am - 09:20am Eastern - March 14, 2022
Joerg Zimmermann, Vetter Pharma-Fertigung GmbH & Co., Vice President, Vetter Development Service, External Affairs

Monday
Harmonization Efforts of PIC/S and the Impact on Aseptic Processing
09:20am - 09:55am Eastern - March 14, 2022
Paul A. Gustafson, 2022 PIC/S Chair, Sr. Corporate Regulatory Compliance & Enforcement Advisor, Regulatory Operations and Enforcement Branch (ROEB), Health Canada

The mission of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) is to lead the international development, implementation and maintenance of harmonised Good Manufacturing Practice (GMP) standards and quality systems of inspectorates in the field of medicinal products.
This session will share insight from a PIC/S perspective on the joint international collaborations involving PIC/S Participating Authorities, European Medicines Agency (EMA), and the World Health Organization (WHO) in advancing a revised version of Annex 1: Manufacture of Sterile Products. Participants will gain understanding of the harmonisation efforts of PIC/S through facilitation of co-operation and networking between competent authorities. The session will also explore the international collaboration on various aspects of the Annex related to aseptic processing.


Monday
Introduction - FDA View
09:55am - 10:00am Eastern - March 14, 2022
Michael G. Higgins, Senior Compliance Advisor, Roche/Genentech

Monday
ORA Update - Navigating our Oversight through Covid-19 & Beyond
10:00am - 10:29am Eastern - March 14, 2022
Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, FDA/ORA

Monday
Closing
10:29am - 10:30am Eastern - March 14, 2022
Joerg Zimmermann, Vetter Pharma-Fertigung GmbH & Co., Vice President, Vetter Development Service, External Affairs

Concurrent Session: Design & Development of Components in Aseptic Manufacturing
11:15am - 12:30pm Eastern - March 14, 2022
Joerg Zimmermann, Vetter Pharma-Fertigung GmbH & Co., Vice President, Vetter Development Service, External Affairs; Sven Filler, Strategic Investment Program Director, Bayer AG; Kara Vogt, Process Engineer, Technical Services, INCOG Biopharma Services; JoAnne Jacobs, Director, Technical Services, INCOG Biopharma Services

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 controlsand push the boundaries of bio manufacturing as we know it. From continuous methodologies to disposable technologies, we explore the industries response to the bio manufacturing capacity challenge.


Monday
Welcome and Introductions
11:15am - 11:20am Eastern - March 14, 2022
Joerg Zimmermann, Vetter Pharma-Fertigung GmbH & Co., Vice President, Vetter Development Service, External Affairs

Monday
Redesigning Ready to Use Components
11:20am - 11:40am Eastern - March 14, 2022
Sven Filler, Strategic Investment Program Director, Bayer AG

Monday
Building Resiliency into Single-Use-Technology Systems
11:40am - 12:00pm Eastern - March 14, 2022
JoAnne Jacobs, Director, Technical Services, INCOG Biopharma Services; Kara Vogt, Process Engineer, Technical Services, INCOG Biopharma Services

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.


Monday
Q&A/Discussion
12:00pm - 12:30pm Eastern - March 14, 2022
Joerg Zimmermann, Vetter Pharma-Fertigung GmbH & Co., Vice President, Vetter Development Service, External Affairs

Concurrent Session: Robotics and Implementation of New Strategies 1
11:15am - 12:30pm Eastern - March 14, 2022
Klaus Ullherr, Senior Product Manager, Syntegon Technology Gmbh; Joseph McCall, Jr., Director of Quality Assurance Technical Services, ADMA Biologics; Kevin Gadient, Director, Manufacturing Sciences & Technology, Emergent BioSolutions; Thomas Thurn, PhD, Director Drug Product Clinical Supply Chain, Janssen Cilag AG; Ruth Barensteiner, Dipl.-Ing. (FH), Principal Scientist Compliance, Janssen Pharmaceuticals

To listen to the recording and view the content from this session click on “Download MP3” and “Download Handout” under Files, to the right of this text.

Robotics and Implementation of New Strategies 1| Robotics provide various benefits, from implementing new strategies and methods to process monitoring. In this session, these aspects are further explored. The first presentation provides insights into the benefits of gloveless, robotic isolators, and advantages from the resulting risk reductions. In the second session, we dive in the advanced analytical technologies and digital tools for continuous environmental monitoring strategy.


Monday
Welcome and Introductions
11:15am - 11:20am Eastern - March 14, 2022
Klaus Ullherr, Senior Product Manager, Syntegon Technology Gmbh

Monday
Production Data from Standard Robotic Filling Workcells
11:20am - 11:40am Eastern - March 14, 2022
Kevin Gadient, Director, Manufacturing Sciences & Technology, Emergent BioSolutions; Joseph McCall, Jr., Director of Quality Assurance Technical Services, ADMA Biologics
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.
Monday
A Step to Human-less Aseptic Operation - Continuous Environmental Monitoring Strategy
11:40am - 12:00pm Eastern - March 14, 2022
Ruth Barensteiner, Dipl.-Ing. (FH), Principal Scientist Compliance, Janssen Pharmaceuticals; Thomas Thurn, PhD, Director Drug Product Clinical Supply Chain, Janssen Cilag AG
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.
Monday
Q&A/Discussion
12:00pm - 12:30pm Eastern - March 14, 2022
Klaus Ullherr, Senior Product Manager, Syntegon Technology Gmbh

Concurrent Session: Robotics and Implementation of New Strategies 2
01:30pm - 02:45pm Eastern - March 14, 2022
Klaus Ullherr, Senior Product Manager, Syntegon Technology Gmbh; Marko Hahn, Dipl.-Ing. (FH), Project Lead, Roche Diagnostics GmbH Mannheim; Daniel Sturm, Global Product Manager, Syntegon Technology Gmbh; Julien Janda, Head of Process & Technology, GMS Global Engineering, Takeda Pharmaceutical International AG

Robotics and Implementation of New Strategies 2|How to use robotics to design a facility for the future in aseptic manufacturing? The second robotics session provides insights into both realized solutions and upcoming challenges in designing a sterile manufacturing facility. The use of robotics can simplify fill-finish manufacturing lifecycle and provide benefits in retrofitting an existing line.


Monday
Welcome and Introductions
01:30pm - 01:35pm Eastern - March 14, 2022
Klaus Ullherr, Senior Product Manager, Syntegon Technology Gmbh

Monday
Retrofit of Innovative Robotic Solutions into Existing Production Lines
01:35pm - 01:55pm Eastern - March 14, 2022
Daniel Sturm, Global Product Manager, Syntegon Technology Gmbh; Marko Hahn, Dipl.-Ing. (FH), Project Lead, Roche Diagnostics GmbH Mannheim

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.


Monday
Facility of the Future on Robotics in Aseptic Manufacturing
01:55pm - 02:15pm Eastern - March 14, 2022
Julien Janda, Head of Process & Technology, GMS Global Engineering, Takeda Pharmaceutical International AG

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.


Monday
Q&A/Discussion
02:15pm - 02:45pm Eastern - March 14, 2022
Klaus Ullherr, Senior Product Manager, Syntegon Technology Gmbh

Concurrent Session: Implementing and Ensuring Robust Contamination Control
01:30pm - 02:45pm Eastern - March 14, 2022
Dina Manfredi, Director of Sales and Business Development, GMP Systems Inc; Jeremiah Genest, Senior Director, Amylyx Pharmaceuticals; Christa B. Myers, Senior Associate, Aseptic & Sterile Market Director, CRB

To listen to the recording and view the content from this session click on “Download MP3” and “Download Handout” under Files, to the right of this text.

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.


Monday
Welcome and Introductions
01:30pm - 01:35pm Eastern - March 14, 2022
Dina Manfredi, Director of Sales and Business Development, GMP Systems Inc

Monday
Contamination Control, Risk, and the Quality Management System
01:35pm - 01:55pm Eastern - March 14, 2022
Jeremiah Genest, Senior Director, Amylyx Pharmaceuticals
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.
Monday
Contamination Control Strategy: From Annex 1 Draft Requirements to Implementation in Practice
01:55pm - 02:15pm Eastern - March 14, 2022
Christa B. Myers, Senior Associate, Aseptic & Sterile Market Director, CRB

As a replacement to Tobias Ladner, PhD and Lorenz Liesum, PhD, Christa Myers will be discussing Contamination Control Strategy: From Annex 1 Draft Requirements to Implementation in Practice.


Monday
Q&A/Discussion
02:15pm - 02:45pm Eastern - March 14, 2022
Dina Manfredi, Director of Sales and Business Development, GMP Systems Inc

Industry Panel: Overcoming the Biggest Challenges in C+G/ATMPs
03:30pm - 05:00pm Eastern - March 14, 2022
Alexander Haig, Vice President, Engineering, INCOG Biopharma Services; Matthew H. Snyder, Associate Director, Engineering & Facilities, Center for Breakthrough Medicines; Mario Miele, Vice President Facilities and Engineering, ElevateBio; Ryan S. McDonough, PE, Senior Vice President Project Operations, DPS; Juergen Michael Metzger, Product Specialist Aseptic Transfer Systems|FMT, Sartorius North America Inc.; Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG; Sumit Verma, Senior Vice President, Commercial Manufacturing, Iovance Biotherapeutics, Inc.

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.


Monday
Opening Remarks
03:30pm - 03:40pm Eastern - March 14, 2022
Alexander Haig, Vice President, Engineering, INCOG Biopharma Services

Monday
Advanced Therapies Aha-Moment
03:40pm - 03:50pm Eastern - March 14, 2022
Ryan S. McDonough, PE, Senior Vice President Project Operations, DPS; Mario Miele, Vice President Facilities and Engineering, ElevateBio; Matthew H. Snyder, Associate Director, Engineering & Facilities, Center for Breakthrough Medicines

Monday
Benefits of Single-use Technology Especially for ATMPs
03:50pm - 04:00pm Eastern - March 14, 2022
Juergen Michael Metzger, Product Specialist Aseptic Transfer Systems|FMT, Sartorius North America Inc.

Monday
Primary or Secondary Containment and its Advantages and Disadvantages for the Manufacturing of ATMPs
04:00pm - 04:10pm Eastern - March 14, 2022
Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG

Monday
TBD
04:10pm - 04:20pm Eastern - March 14, 2022
Sumit Verma, Senior Vice President, Commercial Manufacturing, Iovance Biotherapeutics, Inc.

Monday
Q&A/Discussion and Closing Remarks
04:20pm - 05:00pm Eastern - March 14, 2022
Alexander Haig, Vice President, Engineering, INCOG Biopharma Services

Women in Pharma Breakfast Session: Trends in Aseptic Processing Applications: Impacts of Covid, ATMP, Supply Chain and More
07:30am - 08:45am Eastern - March 15, 2022
Christa B. Myers, Senior Associate, Aseptic & Sterile Market Director, CRB; Jessica J. Frantz, Project Development Engineer, AES Clean Technology, Inc.; 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

To listen to the recording and view the content from this session click on “Download MP3” and “Download Handout” under Files, to the right of this text.

Women in Pharma Breakfast Session: Trends in Aseptic Processing Applications: Impacts of Covid, ATMP, Supply Chain and More |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.


Tuesday
Welcome and Introductions
07:30am - 07:35am Eastern - March 15, 2022
Christa B. Myers, Senior Associate, Aseptic & Sterile Market Director, CRB

Tuesday
Trends in Aseptic Processing Applications: Impacts of Covid, ATMP, Supply Chain and More
07:35am - 08:35am Eastern - March 15, 2022
Paul F. Valerio, Director of Process Technology / Senior Associate, IPS - Integrated Project Services, LLC; Elizabeth J. Dorn, Aseptic Filling SME - Representing Owners Interests in Capital Projects, EliRx; Jessica J. Frantz, Project Development Engineer, AES Clean Technology, Inc.

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


Tuesday
Closing Remarks
08:35am - 08:45am Eastern - March 15, 2022
Christa B. Myers, Senior Associate, Aseptic & Sterile Market Director, CRB

Plenary Session: Microbiological Quality and Cultivating Emerging Leaders
09:00am - 10:00am Eastern - March 15, 2022
Joerg Zimmermann, Vetter Pharma-Fertigung GmbH & Co., Vice President, Vetter Development Service, External Affairs; Joyce Hansen, Vice President of J&J Microbiological Quality and Sterility Assurance, Johnson & Johnson

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.


Tuesday
Keynote: Microbiological Quality and Cultivating Emerging Leaders
09:00am - 09:45am Eastern - March 15, 2022
Joyce Hansen, Vice President of J&J Microbiological Quality and Sterility Assurance, Johnson & Johnson

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.


Tuesday
Q&A/Discussion
09:45am - 10:00am Eastern - March 15, 2022
Joerg Zimmermann, Vetter Pharma-Fertigung GmbH & Co., Vice President, Vetter Development Service, External Affairs

Concurrent Session: Enzyme H2O2-Indicators in Aseptic Production Environment
10:45am - 12:00pm Eastern - March 15, 2022
Christa B. Myers, Senior Associate, Aseptic & Sterile Market Director, CRB; Andreas Demmler, PhD, Team Leader Development Biodecontamination, METALL+PLASTIC GmbH / OPTIMA Pharma; Richard Panton, Principal Engineer, Roche Genentech

To listen to the recording and view the content from this session click on “Download MP3” and “Download Handout” under Files, to the right of this text.

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.


Tuesday
Welcome and Introductions
10:45am - 10:50am Eastern - March 15, 2022
Christa B. Myers, Senior Associate, Aseptic & Sterile Market Director, CRB

Tuesday
Evaluation of Enzyme Indicators for H2O2 Decontamination
10:50am - 11:10am Eastern - March 15, 2022
Andreas Demmler, PhD, Team Leader Development Biodecontamination, METALL+PLASTIC GmbH / OPTIMA Pharma
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.
Tuesday
Enzyme Indicators for Quantifying VPHP Exposure
11:10am - 11:30am Eastern - March 15, 2022
Richard Panton, Principal Engineer, Roche Genentech
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.
Tuesday
Q&A/Discussion
11:30am - 12:00pm Eastern - March 15, 2022
Christa B. Myers, Senior Associate, Aseptic & Sterile Market Director, CRB

Concurrent Session: Process Development & Manufacturing for Highly Potent Substances
10:45am - 12:00pm Eastern - March 15, 2022
Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG; Thorsten Haefner, Director Business Development, Groninger & Co GmbH; Bianca Bohrer, Managing Director, PSM GmbH Topmedicare; Reinhold Maeck, Head of Corp EHS Regulatory Intelligence, Boehringer Ingelheim Corporate Center GmbH

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


Tuesday
Welcome and Introductions
10:45am - 10:50am Eastern - March 15, 2022
Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG

Tuesday
PSM GmbH – Foundation of a New German CDMO in Light of the New EU GMP Annex 1
10:50am - 11:10am Eastern - March 15, 2022
Bianca Bohrer, Managing Director, PSM GmbH Topmedicare; Thorsten Haefner, Director Business Development, Groninger & Co GmbH

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.


Tuesday
Manufacturing of High Potent Substances in Aseptic Manufacturing
11:10am - 11:30am Eastern - March 15, 2022
Reinhold Maeck, Head of Corp EHS Regulatory Intelligence, Boehringer Ingelheim Corporate Center GmbH
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.
Tuesday
Q&A/Discussion
11:30am - 12:00pm Eastern - March 15, 2022
Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG