Webinar: Key Considerations for Cell & Gene Therapy Manufacturing Facilities

Video: Key Considerations for ATMP Manufacturing

This webinar kicks off by examining the gradual transition from using biosafety cabinets to isolators in the manufacturing and R&D of Advanced Therapy Medicinal Products (ATMP) and Cell and Gene Therapy (CGNT). This change is driven by the potential for overall control and a drastic reduction in contamination risk. Despite the significant economic challenges associated with automation (due to the smaller volumes often involved in these operations), Genesis AEC’s ATMP and Biologics Practice Lead, Jeff Odum, CPIP, predicts a future inclination towards automated solutions that can significantly enhance the efficiency of operations involved in manufacturing these types of products.

The webinar addressed some questions:

What does the integration of smart manufacturing, e.g., AI tools, non-invasive sensors, and data science mean for real-time process monitoring in ATMP and CGNT R&D and manufacturing?

While Jeff clarified his limited expertise in AI, he acknowledged the substantial value these high-tech tools and sensors can provide in offering a more accurate and precise assessment of particular attributes. He suggested that as technology and economics align, digital models could certainly be increasingly utilized in ATMP and CGNT production. Furthermore, this is currently the case with traditional monoclonal fed-batch manufacturing processes.

Can you address typical sizes for container lots in the filling process?

Jeff explained that the sizes can considerably vary depending on the therapy type. In autologous cell therapy, where each process is tied to an individual patient, product volume depends on the patient-derived materials. On the other hand, in allogenic therapy, a larger population of donors contribute to the process. In gene therapy, the manufacturing process may resemble traditional monoclonal fed-batch processes, handling larger volumes. Therefore, in the ATMP and CGNT space, lot sizes are not uniform. They tend to be more varied than in the traditional monoclonal antibody therapy world.

Will automated or functionally closed manufacturing platforms potentially minimize the need for environmental control and monitoring?

Jeff confirmed that such platforms are available. He further explained that transitioning from an open process using a biosafety cabinet to a closed process inside an isolator unit operation can significantly mitigate risks associated with environmental contamination. Despite perceived hurdles like cleaning and initial costs, Jeff suggested that the long-term benefits, such as improved risk management and potential endorsement from regulatory agencies, could make this shift worthwhile.

Glossary

1. ATMP (Advanced Therapy Medicinal Products): These are medicines for human use that are based on genes, cells, or tissues. ATMPs offer groundbreaking new opportunities for the treatment of diseases and injuries.
2. Non-invasive Sensors: Devices that can monitor specific conditions or parameters without intruding into the system. Used here in the context of manufacturing and R&D of ATMP and CGNT.
3. Monoclonal Fed-batch Manufacturing Processes: Biotechnological methods used for the production of monoclonal antibodies, using controlled feeding strategies to optimize cell growth and protein production.
4. Autologous Cell Therapy: A type of treatment that extracts, treats, and then returns a patient’s cells to the patient to fight a disease or condition.
5. Allogenic Therapy: A procedure that uses cells from a donor to help a patient’s body recover or replace damaged or destroyed cells, such as within stem cell transplantations.
6. Functionally Closed Manufacturing Platforms: Systems that allow for the production of ATMP and CGNT in a way that particularly minimizes the need for environmental control and monitoring.k

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