Vaccination is a key component of public health policy with demonstrated cost-effective
benefits in protecting both human and animal populations. Vaccines can be manufactured …

Therapeutic antibodies represent the most significant modality in biologics, with around 150
approved drugs on the market. In addition to specific target binding mediated by the variable …

Monoclonal antibodies (mAbs) are established as the most prevalent class of recombinant
protein therapeutics. This introductory chapter attempts to set the context for the following …

A stochastic approach of copurification of the protease Cathepsin L that results in product
fragmentation during purification processing and storage is presented. Cathepsin L was …

To ensure the viral safety of protein therapeutics made in mammalian cells, purification
processes include dedicated viral clearance steps to remove or inactivate adventitious and …

Protein aggregation is a major challenge in the development of therapeutic monoclonal
antibodies (mAbs). Several stressors can cause protein aggregation, including temperature …

We have systematically investigated six compendial nonionic detergents as potential
replacements for Triton×‐100 in bioprocessing applications. Use of compendial raw …

Viral clearance steps are routinely included in monoclonal antibody purification processes to
safeguard product from potential virus contamination. These steps are often experimentally …

Virus safety of biopharmaceuticals produced in cells of animal origin is governed by
regulatory guidelines. It is ensured through raw material controls, cell substrate testing, and …

Monoclonal antibodies (mAbs) are among the fastest-growing therapeutics (see Chapter 3)
and are being developed for a broad range of indications, from cancer to infectious diseases …