Dr. Ravish Patel holds a Ph.D. from Nirma University and brings 18 years of extensive experience in the biopharmaceutical industry, specializing in Biosimilars, Vaccines, Plasma-derived Proteins, Cell and Gene Therapy, and CMC Characterization & Quality (QMS). Throughout his career, Dr. Patel has held key roles at leading pharmaceutical companies, including Sun Pharma, Cipla, Cadila, Intas, Wockhardt, Epygen, and Vitane, where he has contributed to the development, characterization, and regulatory compliance of biologics and advanced therapeutics. A recognized expert in his field, Dr. Patel has actively participated in numerous national and international conferences, sharing insights and advancements in biotherapeutics manufacturing, quality systems, and regulatory strategies. His vast industry experience and technical expertise make him a valuable contributor to the evolving landscape of biopharmaceutical innovation.
A potency assurance strategy is a multifaceted approach that reduces risks to the potency of a product through manufacturing process design, manufacturing process control, material control, in-process testing, and potency lot release assays. The goal of a potency assurance strategy is to ensure that every lot of a product released will have the
specific ability or capacity to achieve the intended therapeutic effect.