2024, Marketing, Packaging and Protein Production

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2024

Marketing

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Protein Production

Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

Agency IQ

APRIL 12, 2024

Draft guidance on potency assays for CGT products garners extensive stakeholder input Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. Should potency assurance plans be submitted? If so, how?

Production

Production FDA Therapies Biochemical Assays

Beyond Steel Tanks

Codon

MARCH 24, 2024

Novo Nordisk’s market capitalization ($442B) is already larger than the GDP of Denmark ( $404B ), the country where the company is headquartered. The market for semaglutide-based products is projected to swell to $71B in less than a decade. ” Finally, “pharmed” drugs are making their way onto the market.

Engineering

Engineering Vaccine Production RNA

Drug Discovery Digest

Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

Beyond Steel Tanks

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