Follow-on Biologics

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diosynth-imageThis webcast will describe the key steps in developing a CHO culture process for manufacturing a follow-on biologic. Analytical characterization of 14 lots of the commercial product provided information about the range in key product quality attributes of the marketed drug. The scientists at SP-Diosynth have developed a process that yields a product that is analytically comparable to the commercially available molecule. Product quality attributes investigated were aggregation, acidic and basic variants, galactose, sialic acid and fucose content, and complement dependent cytotoxicity activity.

Scalability of the process was demonstrated in 100L stainless steel bioreactors and a 50L single use bioreactor (SUB). The webcast shows SP-Dionsyth’s data indicated that the process generates high titer at scale consistently while achieving product quality similar to the commercial material.

With this on-demand webcast, you will gain valuable insight into aspects of SP-Disoyth’s process development, such as:

  • Cell Line Characteristics
  • Scalability
  • Manufacturability
  • Comparability
  • Commercializability
  • The webcast features Sigma S. Mostafa, Ph.D.

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