The role of mass spectrometry (MS) has become more important in most application
domains in recent years. Pharmaceutical analysis is specific due to its stringent regulation …

Host cell proteins (HCPs) are process-related impurities derived from the manufacturing of
recombinant biotherapeutics. Residual HCP in drug products, ranging from 1 to 100 ppm (ng …

Extracellular vesicles (EVs) are membrane structures enclosed by a lipid bilayer that are
released into the extracellular space by all types of cells. EVs are involved in many …

K. phaffii is a versatile expression system that is increasingly utilized to produce biological
therapeutics–including enzymes, engineered antibodies, and gene-editing tools–that …

A survey performed by the AAPS Drug Product Handling community revealed a general,
mostly consensus, approach to the strategy for the selection of surfactant type and level for …

Chinese hamster ovary (CHO) cells are used to produce almost 90% of therapeutic
monoclonal antibodies (mAbs) and antibody fusion proteins (Fc-fusion). The annotation of …

The identification and removal of host cell proteins (HCPs) from biologic products is a critical
step in drug development. Despite recent improvements to purification processes, biologics …

Biopharmaceutical products have seen rapid growth over the past few decades and
continue to dominate the global pharmaceutical market. Aligning with the quality by design …

Recombinant adeno-associated viruses (rAAVs) play a pivotal role in the treatment of
genetic diseases. However, current production and purification processes yield AAV-based …

Therapeutic approaches based on nucleic acids to modulate cell activity have recently
gained attention. These molecules arise from complex biotechnological processes, requiring …