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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 superior 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.

Below are some questions that were addressed during the webinar:

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 be increasingly utilized in ATMP and CGNT production, which 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. For instance, in autologous cell therapy, where each process is tied to an individual patient, the product volume depends on the patient-derived materials. On the other hand, in allogenic therapy, a larger population of donors contribute to the process, and 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 and 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. Biosafety Cabinets: Enclosed, ventilated laboratory workspace for safely working with materials contaminated with pathogens requiring a defined biosafety level.
  3. Isolators: A controlled environment device used in the manufacturing and R&D sectors. These provide a physical barrier to protect against contamination.
  4. Cell and Gene Therapy (CGNT): A process where genetic material is introduced into a person’s cells to fight disease. CGNT is a subtype of ATMP.
  5. Automation: The use of technology to perform tasks without human assistance. In this context, it refers to automated solutions for the manufacturing of ATMP and CGNT.
  6. Smart Manufacturing: A broad term that refers to the use of automation and data exchange in manufacturing technologies, which include cyber-physical systems, the Internet of things, cloud computing, and cognitive computing.
  7. AI Tools: Software or systems that can mimic human intelligence. In this context, they are used for process monitoring in ATMP and CGNT R&D and manufacturing.
  8. 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.
  9. Monoclonal Fed-batch Manufacturing Processes: These are biotechnological methods used for the production of monoclonal antibodies, using controlled feeding strategies to optimize cell growth and protein production.
  10. Autologous Cell Therapy: A type of treatment in which a patient’s cells are extracted, treated, and then returned to the patient to fight a disease or condition.
  11. Allogenic Therapy: A procedure that uses cells from a donor to help a patient’s body recover or replace damaged or destroyed cells, commonly used in stem cell transplantations.
  12. Gene Therapy: A technique that uses genes to treat or prevent disease. In the future, this technique may allow doctors to treat a disorder by inserting a gene into a patient’s cells instead of using drugs or surgery.
  13. Functionally Closed Manufacturing Platforms: Systems that allow for the production of ATMP and CGNT in a way that minimizes the need for environmental control and monitoring.
  14. Environmental Control and Monitoring: The practice of monitoring and controlling the environmental conditions in a given area, such as a laboratory or manufacturing facility, to ensure optimal conditions and minimize contamination risk

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About Genesis AEC

Genesis AEC – an award-winning consulting, architecture, engineering, and construction management firm – has partnered with life sciences companies for more than 25 years to complement the scientific expertise of our clients as they usher in the next generation of life-saving therapies, treatments, and technologies. Whether it’s providing AE support for existing sites; commissioning, validation, and qualification (CQV) for specific processes or equipment; or turnkey design-build solutions, our team blends sound science and technical expertise with quality assurance and safety measures to deliver unparalleled results.