mAbs & Conjugated Proteins
Biocon Biologics is a leader in the science, scale, and complexity of manufacturing monoclonal antibodies (mAbs) and conjugated proteins. Over the years, we have made significant investments in building state-of-the-art facilities for drug substance, drug product, and devices across both mAbs and conjugated proteins. We operate one of the largest antibody-manufacturing capacities in South Asia, with globally compliant manufacturing across microbial and mammalian platforms. Our facilities are optimized for large-scale production, and designed to conform to the most stringent cGMP guidelines, comply with international regulatory standards, and meet client requirements worldwide. This enables us to transform global healthcare by advancing access to affordable biosimilar treatment options.
Drug Substance
Our mAb drug substance manufacturing capabilities span B1, B3 and B5 units, while B4 is focused on conjugated proteins at our Bengaluru location, supporting global supply. These facilities specialize in both upstream and downstream processes, utilizing large-scale stainless steel and/or single-use bioreactors and advanced purification systems. The facilities have approvals from multiple regulatory agencies, and meet global regulatory standards.
The B1 block was the first multi-product drug substance manufacturing facility commissioned, and has EMA and U.S. FDA approvals.
Drug Product
Biocon Biologics’ drug product manufacturing is undertaken at our B1 and B2 units in Bengaluru. These facilities are involved in the conversion of drug substance to drug products of insulins, mAbs, conjugated proteins and peptides in different SKUs such as vials, cartridges, PFS and pens. Drug products manufactured at these sites cater to our clinical and commercial supplies.
The design of these facilities enables flexible manufacturing, ensuring quick adaptation to different production needs and capacities, critical for meeting global demands.
Our drug substance and drug product facilities combine innovation and operational excellence, thereby creating a robust ecosystem to meet global patient needs.
