In the term of medicine, Biopharmaceuticals is an application of living organisms or extraction and/or using by product or component of living organism to prevent, relieve or treatment the human diseases. Biopharmaceuticals are predominantly protein or recombinant protein from biotechnology process e.g. tissue plasminogen activator (tPA), hormones – insulin, growth hormone, hematopoietic growth factor -- epoetin alfa, granulocyte colony-stimulating factor, interferon, and monoclonal antibodies. In addition,
blood component (e.g. factor VIII and factor IX for blood coagulation) and stem cells can also be considered as biopharmaceuticals as well.
For industry, biopharmaceuticals lies at the interface between biotechnology and pharmaceutical manufacturing. Mostly, biopharmaceuticals products may be produced from microbial cells (e.g. recombinant E. coli), or mammalian cell lines in bioreactor under current Good Manufacturing Practice (GMP) and regulated by regulatory agencies.