2022 ISPE Aseptic Conference

Opening Plenary

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.

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.

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.

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.

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.

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.

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.

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.

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.

Interactive Regulatory Panel | This is your opportunity to pose your most pressing quality and regulatory questions directly to a panel of respected FDA thought leaders in the aseptic processing space. This moderated and interactive discussion continues to be a much anticipated and highly rated session for this conference and is always informative; providing insights exclusively to conference attendees. together has changed the role of the industry and has driven value for the world. In our closing plenary session, we will hear from Joydeep Ganguly, SVP of Gilead, regarding how 2020 redefined the role and the value drivers of their efforts. We will also have Rick Friedman, Deputy Director, Science & Regulatory Policy, Office of Manufacturing Quality, CDER/FDA speak about the advantages of modern manufacturing. The session will conclude with a panel discussion including industry and regulatory leaders.