Monoclonal Antibodies

Abstract Lysine (Lys) is a nutritionally essential amino acid with a well-established parenteral safety record, yet its potential as a...

Abstract Inhaled biologics to treat lung diseases have an extensive history. This is counterbalanced by the limited products that have...

Abstract Oxidation represents a key pathway for the chemical degradation of therapeutic monoclonal antibodies (mAbs), and chemical liabilities such as...

Biopharmaceutical excipients are the inactive substances added to biologic drug products to protect large, structurally fragile biomolecules, such as monoclonal...

Abstract There is a growing demand in the subcutaneous delivery of monoclonal antibodies (mAbs) to reduce treatment burden for both...

Abstract In recent years, biologics-based modalities have increased significantly across various therapeutic areas. Monoclonal antibodies (mAbs) and emerging bioconjugates such...

Abstract Preservatives are critical for preventing microbial contamination in multi-dose biologics, yet their compatibility with proteins poses a major challenge....

Abstract Background/Objectives: The development of dry powder formulations for pulmonary delivery of therapeutic antibodies requires careful stabilization strategies to preserve...

Abstract Host cell proteins (HCPs) are process-related impurities in a therapeutic protein expressed using cell culture technology. This review presents...

Abstract Permeation enhancers (PE) such as hyaluronidase are increasingly incorporated into subcutaneous (SC) biologic drug formulations to improve drug absorption....