Newsletter | October 30, 2020

10.30.20 -- Utilizing Analytical Techniques In Biologics Development

Comparing Continuous And Batch Processing In Downstream Purification

Current continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products, including monoclonal antibodies, recombinant proteins, and other biological modalities. Though upstream fed-batch and perfusion bioreactor unit processes are relatively mature, downstream process unit operations are less mature. In this case study, the productivity of purifications running in batch versus continuous mode are compared.

Novel Analytical Techniques For Monoclonal Antibodies

With the rising interest in biopharmaceuticals, drug developers need to quickly understand and evaluate the binding of therapeutic antibodies to Fc receptors. Learn how a new analytical testing panel that uses an Octet-based Fc receptor panel may help developers achieve a faster assessment of monoclonal antibody functionality — well before the final molecule is selected.

Analytical Quality By Design Using Design Of Experiments

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 monoclonal antibody (mAb) used different DoE approaches for rigorous statistical design and analyses for assay development.