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 !!!! 

免责声明:上述内容仅代表发帖人个人观点,不构成本平台的任何投资建议。

精彩评论

  • FabianGracie
    2021-11-27
    FabianGracie
    有趣,但我不相信这种公司会有巨大的进步。没有“打包”的公司能在今天成长。是新能源和元。
  • JackPowell
    2021-11-27
    JackPowell
    我对这些公司知之甚少。你还有其他的建议吗?我更喜欢按行业购买投资组合来分散风险。
  • Jabby
    2021-11-28
    Jabby
    Good coverage! Pls like!
  • BartonBecky
    2021-11-27
    BartonBecky
    新冠肺炎非常糟糕。我喜欢投资针对这种病毒的制药公司。我认为他们有很大的改进空间。
  • 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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