biopharma

Biopharma refers to a sector of the pharmaceutical industry focused on products produced by living systems or biological molecules. Biopharmaceuticals, or biologics, include therapeutic proteins, nucleic acid drugs, vaccines, and cellular therapies. They are typically larger and more complex than traditional small molecule drugs and often require biotech methods such as recombinant DNA technology, fermentation, and cell culture.

Types include monoclonal antibodies, recombinant enzymes, fusion proteins, vaccines, gene therapies, and cell therapies (such as CAR-T). Biopharmaceuticals are typically administered by injection or infusion and may target cancer, autoimmune diseases, rare diseases, infectious diseases, and other conditions. Diagnostics can also play a supporting role in biopharmaceutical development and treatment.

Development and production involve discovery, preclinical evaluation, clinical trials, and regulatory review. Manufacturing relies on bioprocessing: upstream processes like cell culture or fermentation to grow biological material, followed by downstream purification, formulation, and fill-finish. Good manufacturing practice guidelines govern production, quality control, and pharmacovigilance. Scale-up from laboratory to commercial production adds substantial technical and cost challenges.

Industry structure and regulation include large pharmaceutical companies, biotech startups, contract research organizations (CROs), and contract manufacturing organizations (CMOs). Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) evaluate safety and efficacy and enforce manufacturing standards. Intellectual property protection, pricing, and reimbursement influence market access and patient availability.

Trends and landscape feature advances in gene therapy, mRNA technologies, and cellular immunotherapies, as well as shifts toward continuous bioprocessing, single-use systems, and increased digitalization. Global supply chains and regulatory harmonization remain important for ensuring access and safety.