Highlights•Proteins undergo spontaneous degradation during manufacturing and
storage.•Chemical modifications to proteins can influence physical stability.•Predictive tools …

Protein pharmaceuticals have become a significant class of marketed drug products and are
expected to grow steadily over the next decade. Development of a commercial protein …

The biopharmaceutical industry has an ongoing interest in improving manufacturing
efficiency and productivity while at the same time reducing manufacturing costs by …

Peristaltic pumping during bioprocessing can cause therapeutic protein loss and
aggregation during use. Due to the complexity of this apparatus, root-cause mechanisms …

To achieve the high protein concentrations required for subcutaneous administration of
biologic therapeutics, numerous manufacturing process challenges are often encountered …

This work examined the use of single-pass tangential flow filtration (SPTFF) to concentrate
cell culture harvest. Conventional tangential flow filtration (TFF) is routinely used in …

Excipient concentrations are critical quality attributes of monoclonal antibody (mAb) drug
products and affect their safety and efficacy. In manufacturing processes, mAb products are …

Ultrafiltration (UF) is used for the final concentration and formulation of essentially all
antibody‐based therapeutics including both monoclonal antibodies (mAbs) and Fc‐fusion …

The foundation of a biosimilar manufacturer's regulatory filing is the demonstration of
analytical and functional similarity between the biosimilar product and the pertinent …

Abstract Recombinant Adeno-Associated Viruses (AAVs) are increasingly being used as the
choice of vectors for gene therapy applications. While ultrafiltration is the unit operation in …