The ISPE Aseptic Conference has been setting the pace for the evolution of sterile manufacturing processes and technologies in the pharmaceutical industry for 30 years. On March 15-17, the 30th Annual ISPE Aseptic Conference took place and Project Farma SMEs presented on the topics of ‘Utilizing Modular Cleanrooms and Single-Use Technologies’ and ‘Advanced Therapeutics Manufacturing Strategy: Make vs. Buy’:

Utilizing Modular Cleanrooms and Single-Use Technologies
Speakers: Joe Neroni, Director at Project Farma; Scott Bertch, Executive Director at Tenaya Therapeutics

Joe Neroni and Scott Bertch discuss the unique nature of advanced therapy facilities with a focus on the advantages of using modular cleanrooms and single use technologies in cell and gene therapy. Primary topics include discussion of the following: Modular cleanrooms, Single-use technologies, Advantages of each, Advantages of flexible manufacturing in advanced therapies and Any shortcomings of these technologies.

Advanced Therapeutics Manufacturing Strategy: Make vs. Buy
Speakers: Parla Hoelter, Sr. Consultant at Project Farma; Daniel Foody, Sr. Manager at Project Farma

Parla Hoelter and Danny Foody detail the considerations used in determining whether an advanced therapy company should manufacture therapies internally, utilize external third-party manufacturers or use a hybrid approach. This discussion explores the rationale of cell and gene therapy companies using an external CMO or relying on internal manufacturing. With insight from an advanced therapy company that utilizes internal and external manufacturing, Project Farma provides the considerations for both cases.

To learn more about the ISPE Aseptic Conference, click here!