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Aseptic Conference Provides Solutions to Pharmaceutical Challenges

Jörg Zimmermann
2022 Aseptic Conference

It is a great honour and pleasure for me as the 2022-2023 ISPE Board Past Chair and Chair of the 2023 ISPE Aseptic Conference Program Committee to give you a first glimpse at the program and of the information and knowledge that will be shared at the conference.

Building on the success of the conference over the last decades, we have developed a program covering all the hot topics in Aseptic Processing: cell & gene therapy products, advanced therapeutic medicinal products (ATMPs), small scale and clinical manufacturing, barrier and isolator technology, single-use components, robotics in aseptic processing, Annex 1 revision and implementation strategies, cleaning and disinfection, training and many more. Several sessions will cover facility and process case studies from around the world.

You will get answers to the following questions:

  • How were the fill-finish processes for the SARS CoV-2 vaccines developed and qualified, and how did the manufacturers manage to provide vaccine doses in such large quantities in such a short time?
  • SARS CoV-2 vaccines have been formulated in lipid nanoparticles. What needs to be done to properly clean equipment used in these processes?
  • Setting up a fill-finish process for a high-potent, oncology product in a prefilled syringe: what were the unique challenges?
  • Are modular prefabricated and mobile units the way to go for aseptic processing?
  • What did companies learn during the early development stages for CRISPR/CAS therapies?
  • How can affordable medicines be produced for highly prevalent diseases like diabetes?
  • Contamination Control Strategy is a key principle of Annex 1. What do companies have to do to develop this strategy to satisfy the regulations?
  • What does KAIZEN for aseptic processing look like?
  • Blow-fill-seal containers are commonly used for various dosage forms, what are the latest developments in this field?
  • How is the technology for blow-fill-seal affected by the more detailed descriptions in Annex 1?
  • Can drone-like sensors help pinpoint the positions in aseptic processing where glass-containers get damaged?
  • Is virtual reality the right tool to do basic training for operators in fill-finish operation?
  • Where is the development of low concentration H2O2-decontamination heading?
  • Are there new results available from the research into enzyme indicators as an alternative to biological indicators for H2O2?
  • When buying new equipment for a filling line, how are competing bids from equipment manufacturers best compared and evaluated?
  • What have companies learned in the investigation of microbial excursions in clean-rooms, and which new technologies help correctly identify the micro-organisms?
  • Project RiskSurve from FDA: a project to create a comprehensive site surveillance model consolidating data from different dimensions: what are the first learnings?

The conference speakers come from around the world and provide unique, multi-faceted perspectives on the topics. In real-life case studies, they will share their learnings with solutions that you can apply to your challenges immediately.

In addition to the topical tracks, there will also be workshop-type discussion groups where you can directly interact with your fellow participants and ask your questions in an open forum. This section of the program brings the most actionable learnings and has been described as one of the highlights of the conference.

But wait, there is even more:

Annex 1 which is regulating the manufacturing of sterile products in the EU and will also be adopted by PIC/S and WHO has finally been published on 25AUG2022.
We have organized a distinguished industry panel to discuss the impacts of this guideline. Most importantly, the panellists have actively been involved in the commenting process via ISPE and other organizations and can give background information on the document and it’s interpretation.

In terms of keynotes, as in past years, this conference has a top line-up of speakers:

Brooke Higgins
Senior Policy Advisor for the Global Compliance Branch 3
FDA

Brooke Higgins, Senior Policy Advisor for the Global Compliance Branch 3, FDA has chosen the following title for her presentation: “Testing Positive…. A Look into Media Fills, Environmental Monitoring and Parametric Release”.


Emily Craven
Director, Global Sterility Assurance
Boston Scientific

Emily Craven, Director, Global Sterility Assurance, Boston Scientific will be talking about: “Opportunity and Growth: How supply chain challenges in sterilization methods could impact the manufacturing of sterile dosage forms”. This keynote will try to bridge the gap between the medical device industry and the pharmaceutical industry. Both rely to an extend on outsourced sterilization services, which is where the industry is currently faced with acute shortages and needs to find alternatives. I am eager to hear what Emily will have to tell us.

Additionally, the ISPE Aseptic Conference is one of the very few events with an open panel discussion with regulators from FDA. This open forum enables you to directly address your questions to the panelists in a larger group. Both industry and regulators have profited from this exchange in the past, gaining a better understanding of seemingly contradictory positions. At the 2023 Aseptic Conference, the focus will be on pharmaceutical-technical issues around the production of sterile products.

If you want to find out what was discussed at the 2022 conference, you can find a write-up here.

Above all, the conference provides ample opportunities to network with your peers, learn about new products in the exhibit hall, and socialize over a beverage or two.

If there is one conference in the field of Aseptic Processing that you cannot afford to miss, then this is the one. We hope to see you in person in Bethesda, MD in March!

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