Biocon Biologics has a proven track record in the science, scale, scope and complexity of biologics manufacturing. Over the years it has invested heavily in building biologics facilities for drug substance, drug product and devices for both insulins and monoclonal antibodies.

We have a portfolio of eight biosimilars developed at Biocon Research Centre which have been commercialized in over 100 markets globally.

These biosimilars are produced at our large scale, globally compliant manufacturing facilities — two in Bengaluru, India, and one in Johor, Malaysia.

We have multiple high-end technology platforms spanning microbial fermentation, mammalian cell culture, protein & antibody purification etc to develop biologics Drug Substances and Drug Products, including devices.

Our proprietary technology using Pichia pastoris platform for expressing recombinant protein is used in the recombinant human insulin and insulin analog product lines.

Our consistent and scalable mammalian CHO and NSO cell-based expression platforms are helping us deliver novel and biosimilar monoclonal antibodies.

The upstream and downstream processes continually incorporate latest innovations in cell culture and purification. Our advanced analytical capability, which is anchored in cutting-edge tools and latest orthogonal approaches, guarantees the high quality and consistency of our products.

The production of drug substance in the state-of-the-art bio-manufacturing facilities ensures cost effective production. Our expertise in Formulation & Product Science enables us to convert drug substances into formulations for transfer into vials, cartridges and pre-filled syringes at our biologics drug product facilities. Our manufacturing facilities are designed to conform to the most stringent cGMP guidelines, comply with international regulatory standards and meet client requirements worldwide. They are supported by state-of-the-art process development and quality control laboratories and an efficient service infrastructure.

The facilities have received cGMP approvals from over 25 international regulatory agencies, including the U.S. Food and Drug Administration and the European Medicines Agency.

Our investments in building on a global scale have led us to rank among the world’s Top 15 biomanufacturing companies*. We are among the leading insulin producers worldwide and have one of the largest antibodies manufacturing capacities in South Asia.

We are continuously looking at ways to strengthen our quality culture and improve our systems and processes to best-in-class regulatory standards. Digitalization and automation is a critical part of our strategy and plays an important role in ensuring consistency of quality and process efficiency.

*Source: 19th Annual Report and Summary of Biopharmaceutical Manufacturing Capacity and Production, Bioplan Associates 2022

Malaysia: Center of Excellence (CoE) for Insulins

Biocon Biologics has created a Center of Excellence (CoE) for insulins in Malaysia with end-to-end capabilities to manufacture a broad portfolio of regular, basal and rapid insulins. The state-of-the-art insulins facility in Johor is the first and only biopharmaceutical sterile injectables facility in Malaysia to receive the U.S. Food and Drug Administration (FDA) and European Medicines Agency approvals. More recently, Biocon’s biosimilar insulin Glargine made at Malaysia received a historic U.S. FDA approval as the ‘first interchangeable biosimilar’.

The 562,000 sq. ft. facility has been recognized as the first and largest integrated insulin manufacturer in Malaysia by the prestigious Malaysia Book of Records, which officially recognizes record-creating and record-breaking achievements in the fields of human endeavour, building & structures, transportation, arts & entertainment, business, sports & games, science & technology, nature etc. in Malaysia.

Our facility in Malaysia is Asia’s largest integrated insulins facility that manufactures Drug Substance and Drug Products in vials, cartridges and insulin delivery devices.