Need For Advanced Manufacturing Technologies A ‘Great Learning’ From The Pandemic, CBER’s Marks Says

 
• By Sue Sutter

COVID-19 highlighted limited domestic capacity and need for more flexibility, agility and reliability in manufacturing processes, says FDA biologics center director Peter Marks; he also discussed differences in data review for vaccine BLAs relative to EUAs.  

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Limited capacity and agility in domestic manufacturing sites is one of CBER director Peter Marks' lessons learned from the pandemic. • Source: Alamy

Implementing advanced manufacturing techniques before the next pandemic will enable speedier ramp-up of vaccines for emerging infectious diseases and could broadly benefit the regenerative medicine field, the head of the US Food and Drug Administration’s biologics center believes.

“I would be remiss if I didn’t share with you one of my great learnings from this pandemic and that...

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