The COVID-19 pandemic is pushing our industry to accelerate the development and supply of vaccines and treatments at a rate never seen before. The use of a pre-fabricated modular approach to designing and constructing cGMP manufacturing using autonomous cleanroom can be an effective approach at meeting these new challenges. The benefits and value of modular manufacturing can only be achieved through a partnership with regulators. The U.S. FDA has discussed the use of prefabricated modular manufacturing with industry stakeholders prior to the pandemic and will discuss how this technology may enable the rapid increases in capacity needed as a result of this global event.
The panel presentation will include technical, regulatory and industry leaders who will share their unique perspectives and experiences on how this critical technology can support advancing the manufacture of high-quality drugs that are not only safe and effective but can also be delivered to a global patient population expeditiously.
- An overview of the autonomous cleanroom system design and applications.
- Comparison of traditional versus pre-fabricated offsite cleanroom construction.
- Benefits of an autonomous cleanroom based facility approach. Specifically, as a response to the manufacturing needs as a result of the COVID-19 pandemic.
- FDA stakeholder engagement activities related to prefabricated modular facilities.
- General understanding of the regulatory challenges related to the implementation of mobile manufacturing.
- Merry Christie, PhD, Product Quality/CMC Team Lead, Office of Biological Products, Office of Pharmaceutical Quality, CDER, U.S. FDA (Invited)
- Brian Horman, VP Facilities & Engineering, Just-Evotec Biologics
- Laurie Norwood, President, Norwood Biologics Consulting LLC
- Thomas O’Connor, PhD, Director, Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, CDER, U.S. FDA
- Dennis Powers, Vice President Business Development & Sales Engineering, G-CON Manufacturing Inc.
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