Summary: Viral clearance studies are mandated prior to entering clinical trials and for the commercial launch of biopharmaceuticals. These studies are a key component of risk mitigation to reduce the potential for iatrogenic transmission of pathogenic viruses.
Summary: This article is a selection of articles published in BioMed Central Ltd., giving overview on the ability to site-specifically conjugate a protein to a payload of interest has found widespread application in basic research and drug development…
Summary: This article is a selection of articles published in The Scientist, giving overviews on new ideas for antibody-drug conjugates designs so oncologists can aim a chemical payload at any cell for which they can identify a specific antigen, such as the HER2 receptor on breast cancer cells…
Summary: In the recent years, multiple optimizations and advances have been made to the classic antibody generation process to make it scalable, reproducible, and commercially viable. This article describes a strategy to get consistent highly pure products…
Summary: Jennifer Mitcham, SMARTag® business development, Catalent Biologics, offers insight into the new generation of antibody drug conjugates and the increasing importance biologics play in the fight against disease…
Summary: In Biologics, the market climate requires increasing speed to move the product to the next phase of development. Even before a product is proven effective in clinical trials, several decisions must be made…
