Biography
Biography: Alok Bandyopadhyay
Abstract
Biopharmaceuticals like monoclonal antibodies are widely used in clinical medicine for various therapies e.g. cancer, inflammatory and autoimmune diseases. Several biosimilar drugs, supposed to be economical version of branded biological drugs, are in the process of drug development for market approval. Unfortunately, biosimilar manufacturing is often different from the brand name drug due to variation in manufacturing processes. As a result, such variations may trigger unwanted clinical issues, which may limit the use of biopharmaceuticals. Well engineered cells, well designed formulation coupled with good manufacturing scheme may sometimes reduce some of the extrinsic and intrinsic factors and increase the stability of drug product. One of the proposals for remedies is to purify the drug product to homogeneity or near homogeneity retaining its stability and functional activity. Due to its low or negligible content of impurities clinical issues may not be triggered and may get a relief from rigorous clinical studies. In addition, incorporation of risk based approach, which considers both probability of induction of clinical issues and expected clinical consequences followed by risk mitigation during drug development, may provide better regulatory pathway for market approval.