jayc
2021-11-27

$Novavax(NVAX)$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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精彩评论

  • FabianGracie
    2021-11-27
    FabianGracie
    Interesting, but I don't believe this kind of company is going to make huge progress. There are no "packaged" companies that can grow today. it's new energy and meta.
  • JackPowell
    2021-11-27
    JackPowell
    I know very little about these companies. Do u have any other recommendations? I prefer to buy a portfolio by sector to spread the risk.
  • Jabby
    2021-11-28
    Jabby
    Good coverage! Pls like!
  • BartonBecky
    2021-11-27
    BartonBecky
    COVID-19 is veryyyy bad. I like to invest in pharmaceutical companies that are specific to this virus. I think they have a lot of room for improvement.
  • AgathaHume
    2021-11-27
    AgathaHume
    Seems to be a good investment choice, once their technology can break through, it will affect their business. very welll
  • Tracccy
    2021-11-27
    Tracccy
    Their technology seems to have a big market, but it doesn't look like it's going to take a lot of market share. so it's not mine.
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