02.24.21 -- Improving Biologic Success During Development And Manufacturing

The number of more complex biopharmaceuticals in development continues to increase, and some of these include molecules that require multiple proteins to be expressed at differing ratios to produce the correct biopharmaceutical. In this article, the authors outline cell line development and process scale-up for an antibody program in which the antibody requires additional processing by a site-specific enzyme for correct functionality.

Bringing a biologic to market is not easy, and there are several key considerations to how sponsor companies should approach commercial-scale manufacturing that may aid the success of their product’s commercial launch. In this article, experts share how scale-up, regulatory expectations, demand forecasting and process validation play into the success of a biologic's commercial manufacturing journey.

Conducting a pilot formulation study at the early drug substance development stage can make things considerably easier at the manufacturing stage. Read how Catalent Biologics utilizes automation, specifically the Uncle platform, during formulation development.

With CDMOs commonly receiving analytical methods at different stages, a different design of experiment (DoE) approach can be used for assays that differ in level of readiness for said CDMO’s assay development pipeline. This scientific poster demonstrates how a panel of analytical assays designed for a mAb used different DoE approaches for rigorous statistical design and analyses for assay development.