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Industry experts discuss how FDA’s response to COVID-19 and related pandemic-related guidance documents may impact the biologics industry long term.
The COVID-19 pandemic brought on new challenges for the pharmaceutical industry, prompting regulators to quickly develop temporary guidelines to address pharmaceutical manufacturing during the health crisis. When it comes to sterile manufacturing, the urgency of COVID-19 vaccine production has showed how important the use of technology is to add capacity when needed, according to the Parenteral Drug Association (PDA) COVID-19 Task Force, including the use of mobile manufacturing platforms. So, how will these production challenges and short-term regulations impact the future of the industry?
There are principles found in these guidance documents that may be applicable to pharmaceutical development and manufacturing after the pandemic has ended, according to the PDA COVID-19 Task Force. Specifically, FDA’s Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19 may be useful in the long term for fast-tracking medicines that fulfill unmet needs (1). Data gained from the agency’s guidance on container closures (2) may be used to gain insight on how efficiencies and principles could be more widely applied, according to the Task Force, leading to revised or new guidance documents.
FDA’s guidance on potential transmission of COVID-19 in cell and gene therapies (CGT) (3) raises risk assessment and cross-contamination questions that may need to be answered because of supply chain changes, the Task Force noted, especially the use of sterile fill/finish facilities that manufacture live viral vectors. Cross-contamination from a variety of areas (e.g., employees, materials, and equipment) also should be reviewed.
Kelly Davis-Claeys, director, regulatory affairs at Catalent Bloomington, and Mo Heidaran, vice president, technical at Parexel Consulting, provide additional insight into the future impact of these pandemic challenges and short-term regulations in the following.
Susan Haigney is managing editor of Pharmaceutical Technology.
eBook: Biologics and Sterile Drug Manufacturing, May 2021
When referring to this article, please cite it as S. Haigney, “The Impact of COVID-19 on Biologics Regulations," Pharmaceutical Technology Biologics and Sterile Drug Manufacturing eBook (May 2021).