biomanufacturing

Biomanufacturing is the production of biologically derived products using living cells or organisms. It covers processes that harness biological systems to manufacture therapeutic proteins, vaccines, enzymes, cultured cells and tissues, and bio-based materials. It spans research-scale development in laboratories to commercial-scale manufacturing in dedicated facilities.

The workflow typically comprises upstream processing, where cells or microbes are cultivated in bioreactors to produce the target product, and downstream processing, where the product is separated, purified, formulated, and subjected to quality control. Upstream platforms include mammalian cell culture for complex proteins and microbial fermentation for enzymes and other bioproducts. Downstream steps rely on filtration and chromatography to achieve adequate purity and safety. All steps are designed to be scalable and reproducible, with process controls guided by quality by design (QbD) and process analytical technology (PAT).

Major applications include therapeutic biologics such as monoclonal antibodies and recombinant proteins; vaccines and viral vectors; industrial enzymes; and diagnostics. More recently, biomanufacturing supports cell therapies, gene therapy vectors, cultured meat, and the production of bio-based chemicals and materials.

Regulatory oversight requires compliance with good manufacturing practice (GMP), thorough validation, and robust quality assurance. Documentation, supply-chain controls, facility qualification, and ongoing monitoring are essential. Ongoing innovations—such as automation, single-use systems, continuous manufacturing, and real-time analytics—aim to reduce cost and risk while ensuring product safety and consistency.