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! This event is free to attend but has limited availability.Session Leader(s):
Identification: SESP1Session Leader(s):
Sterile manufacturing operations remain one of the highest risk pharmaceutical processes. This talk will include a discussion of recent cases and causes of media fill failures and positive sterility tests and will illustrate the critical role of a robust and meaningful environmental monitoring program in all aseptic processes, ranging from older processing lines to modern isolators. We will also examine examples of the careful and precise steps to ensure the quality of aseptically produces drug products and discuss the need for a strong sterility assurance program and quality system to support parametric release of terminally sterilized products.Speaker(s):
In this presentation, Roberto Conocchia will share information about the process leading to the updated Annex 1. This will include information about the consultation processes, the stakeholders giving input to the development of the updated document, as well as a review of the key changes of the updated Annex 1.Speaker(s):
Concurrent Session: Process Control and Quality Risk Management |This session will provide state-of-the-art examples and tools for process control and quality risk management. Presentations will cover topics from Continuous Process Verification (CPV) to strategies for creating a holistic understanding of the quality system; and Annex 1 approaches to risk activities, including risk assessment tools that will enable the contamination strategy goals.Speaker(s):
In the end, it all comes down to manufacturing the drugs on a commercial scale. Many challenges have to be overcome. This year’s aseptic conference has dedicated two sessions to manufacturing case studies. The first of these contains three case studies with very different requirements that must be solved. What they have in common is that they will lead the way for the future:
1) How to introduce a lifesaving vaccine as fast as possible by finding the appropriate approach through all the stages of manufacturing.
2) The filling of high potent drugs into syringes where established processes like outside washing (of the vial) cannot be applied.
3) Embracing the diversity of packaging materials on a multi-purpose fill/finish line for many different kinds of ready-to-use containers.
The rapid introduction of a pandemic vaccine created a challenge to the classical sequential approach to process characterization, transfer, and validation at production scale. The following presentation discusses Moderna's risk based and parallel characterization approach to process validation during the introduction of its drug substance manufacture of the Spikevax vaccine. Moderna transferred in the production process in parallel with process characterization resulting in accelerated deployment of a validated process.
In addition to the rapid introduction and regulatory approval of the prototype vaccine, Moderna has had to respond to variant mutations to allow for further production of this life-saving vaccine. These additional transfers and validations occur at an even further expedited rate to stay ahead of the continued mutation. The approach to variant production will also be discussed.Speaker(s):
We will address conceptual topics and detailed challenges during design and implementation of high-speed syringe filling line for High Potent drugs. Challenges of mock-up, risk assessment, process design will be presented and discussed. Project management pros and cons will be presented.
Initial structure of the presentation:
• Project set up and Project Management (funding, time line, site decision, why syringes)
• Choice of filling line and isolator
• Learnings from the mock-up study
• Integration into the building (Layout, air management)
• Strategy for filling toxic drugs (cleaning, operator protection)
• Special challenges when filling toxic drugs into syringes (e.g., no outside washing possible!)
• Use of NTT (No-Touch-Transfer) with fully automatic bag opening for inner and outer bag
• Impact assessment of new Annex 1 for EU GMP
The biopharma industry megatrends continue to show significant growth in the foreseeable future. The need for flexibility, scalability, and speed-to-market is key for success to meet market demand and avoid potential drug shortage. INCOG BioPharma Services’s new multi-use filling line firmly roots and demonstrates that the ready-to-use platform and bulk vials can coexist in one solution to achieve ultimate flexibility for CDMOs. Robotics technology and automation creates ultimate flexibility to serve clinical and commercial manufacturing needs and serve as a scalable solution for future high speed filling lines as well as accelerating technical transfer programs.Speaker(s):
This session will provide state-of-the-art examples and tools for process control and quality risk management. Presentations will cover topics from Continuous Process Verification (CPV) to strategies for creating a holistic understanding of the quality system; and Annex 1 approaches to risk activities, including risk assessment tools that will enable the contamination strategy goals.Session Leader(s):