Skip to main content
18.97.14.81

Tags: Biologics

All Categories (1-4 of 4)

  1. VENKATREDDY SUNKARA

    Senior Regulatory Affairs Director with a demonstrated history of 18 years experience in Biologics/Pharmaceuticals (API & Drug Product) products registration with Global regulatory authorities...

    https://cmkc.usp.org/members/1476

  2. Yongzhao Pan

    https://cmkc.usp.org/members/1232

  3. Kirti Narsai

    Kirti has 25 years’ experience in the healthcare industry and held board positions in several large organisations with Pan African interests & was a member of the African Regional...

    https://cmkc.usp.org/members/1149

  4. Accelerating biologics manufacturing by modeling or: Is Approval under the QbD and PAT approaches demanded by authorities acceptable without a digital-twin?

    09 Jun 2023 | Contributor(s):: Zobel-Roos, Steffen, Schmidt, Axel Mestmäcker, Fabian Mouellef, Mourad, Huter, Maximilian, Uhlenbrock, Lukas, Kornecki, Martin, Lohmann, Lara, Ditz, Reinhard, Strube, Jochen

    Innovative biologics, including cell therapeutics, virus-like particles, exosomes, recombinant proteins, and peptides, seem likely to substitute monoclonal antibodies as the main therapeutic entities in manufacturing over the next decades. This molecular variety causes a growing need for a...