ok_老虎社区_美港股上老虎

2021-11-28

@jayc：$Novavax(NVAX)$I reviewed all GMP and cGMP certificates for the Novavax's global sites. I can fully understand why Novavax leveraged the manufacturing partnership with Serum. This strategy really makes their CMC package harmonized and simplified as Serum's MHRA GMP certificate covers full line-up of the manufacturing operations from DS/DP to QC Testing without requiring any combinations of sites. Serum's MHRA GMP Coverage 1. Manufacturing Operations 2. 1.1 Sterile Products 3. 1.3 Biological medical products 4. 1.4 Other products or manufacturing activity 5. 1.5 Packaging 6. 1.5.1 Primary packaging 7. 1.5.2 Secondary packaging 8. 1.6 Quality control testing If Novavax uses other global sites, they need to combine several sites to manufacture Nuvaxovid from DS to DP (fill & finish). This makes their CMC package complicate to keep consistency each for the regulatory agencies and difficult to get approval quickly. No other single site can cover full line-up of the manufacturing operations except Serum. Novavax made the best choice to get their CMC package optimized. Fantastic strategy !!!!

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