Annex 1, ATMPs and Pharma 4.0 - How Do They Fit Together

Maria Amaya, Lead External Advocacy North America (Quality Policy) at Genentech, and Jean-François Duliere, Regulatory Advisor at ISPE, are honoured to co-chair Track 1 Annex 1, ATMPs and Pharma 4.0™: How do they fit together?” The sessions in this track address technical aspects under discussion which could impact ATMP’s manufacturing:

• Air Velocity at the working place in aseptic processes
• Validation and Qualification approach in the new Annex 1 for particle counts
• Contamination Control Strategy (CCS) development for ATMPs
• Innovation and Continuous Manufacturing

The track will wrap up with a panel discussion featuring the esteemed speakers from the track sessions, and there is also a potential for remote engagement by regulatory authorities. The objective of this exciting programme aims to demonstrate that Annex 1 can be applied to ATMPs and Pharma 4.0™ and that embracing innovation will improve the robustness of manufacturing ATMPs, even when manual steps are involved. Subject matter experts from the industry will share their knowledge on these topics and address remaining inquiries related to the Annex 1 implementation, adding depth to the ongoing discourse.

Some details of the sessions that will be included in Track 1 are as follows:

• Annex 1 in Europe is based on Quality Risk Management. It still requires air velocity measurement in the range of 0,36m/s – 0,54 m/s at the working place. Data from a session supports the notion of prioritising "at working position" measurements and ISO-level air velocity control rather than attempting "at working level" measurements, aligning with WHO guidelines. This approach not only enhances product quality by avoiding disruptive turbulence from high air velocity at 0.45 m/s "at working level", but it also conserves energy by reducing conditioned and recirculated air volume and improves the reproducibility of air velocity measurements. Embracing established practices proves more prudent than excessive analysis, with cleanroom airflow design requiring validation through airflow visualisation studies.
• We will introduce a visionary approach to develop a Contamination Control Strategy (CCS) for ATMPs based on Holistic Risk Assessment. This development should consider all the risks associated with each process and have a well-defined plan to manage those risks based on data. The presentation will explain a step-by-step approach to CCS, including gathering detailed data about process-related risks and implementing appropriate risk control measures. In the case of ATMPs, the presentation shows data and insights from implementing the Frame-by-Frame Risk Profiling Pilot at Johnson & Johnson CAR-T. With some focus on Pharma 4.0™, the presentation will include data from VR simulator sessions based on risk profiling (as part of end-to-end CCS), and a look ahead to the use of using AI for further development of Frame-by-Frame Risk Profiling.

Annex 1 has incorporated several new aspects of cleanroom classification. What modifications have changed the validation concept because of Annex 1? What aspects remain unchanged? What are essential points for environmental monitoring topics? How can hardware, software, and process understanding be combined to create good GMP validation documents?

A good way to build in quality by design!

We invite you to participate in this captivating event set in the splendid city of Barcelona, Spain. Join us at the 2023 ISPE Pharma 4.0™ and Annex 1 Conference to engage in valuable networking opportunities with fellow professionals and discuss these critical topics that are relevant to our industry.

Register Now!