To address the technologies and regulatory cornerstones of these products, ISPE is introducing a workshop in Brussels in September 2019. The workshop will be offered as an additional, extra activity at the 2019 ISPE Europe Biotechnology Conference.
ATMPs, such as Cell - and Gene therapy, will become the products of the future, addressing personal medicines tailored to the patient needs. The field of ATMPs is large. However, compared to other biopharmaceutical processes, such as cell culture processes, the production technologies as well as the interpretation of regulatory guidance’s are significant hurdles to speed up ATMPs to enter the market.
The objective of this workshop is to elaborate together on the following aspects to modify with technology ATMP production:
Define a process definition for industrial production
Design a production area around the process
Define suitable process equipment
Discuss support of innovative IT systems
Strategies to flexible production along patient’s raw material variability
Consider logistics constraints
The workshop will also present regulations around these products. The following topics will be presented and discussed:
How to identify current GMPs regulations for ATMPs and gaps
How we develop industrial production facilities in respect to Quality Risk Management and Quality by Design
How to deal with very small batch numbers in terms of validation and review
Is a production facility required?
How can new technologies and HMIs support the shop floor operation to save time?
Can we produce ATMPs at hospitals?
The purpose of the workshop is to work within small groups to share thoughts and knowledge around the products of the future. Several subject matter experts will mentor and monitor the workshop sessions in order to generate and drive operational content.
Specific technical topics and regulatory requirements will be illustrated beforehand in order to align all participants to achieve the workshop goal operational content. The content will be defined in sub-groups according to the participants expertise.
Participants willing to deliberate around these topics are welcome to participate.
Join us and register online for the workshop! |