Biosimilar App Notes & Case Studies

  1. Quantitation Of Retrovirus-Like Particles (RVLPs) In CHO Derived Products 3/11/2022

    Review key methods which are applied to ensure safety of such recombinant proteins, with a focus on alternate and superior methods to the standard transmission electron microscopy (TEM) method.

  2. COVID-19 Impact To Biological Drug Products Safety 6/13/2022

    Review currently available literature and our recommended COVID-19 virus detection test methods and susceptibility of common biological host cells to infection.

  3. Developing A HIC Polishing Step For The Removal Of mAb Aggregates 9/28/2023

    Learn in-depth about the development of a flow-through polishing step that employs hydrophobic interaction chromatography for the elimination of monoclonal antibody aggregates.

  4. Overcoming The Challenge Of Maintaining Sterility At Low Temperature Storage 3/24/2023

    Learn about a biotech company with a recently approved gene therapy product that needed to select a packaging solution to meet their needs for storage at low temperatures and still get to market quickly.

  5. Process Control And Performance Of A Depth Filtration System 1/24/2023

    Explore a demonstration of strategic process control in terms of flow and pressure, by utilizing a depth filtration system, for effective depth filter processing and recovery of excess product.