Why Precise Manufacturing of Biological Medicines Matters

How biological medicines are manufactured directly affects their efficacy and safety as medications.

Biological medicines are typically derived from living organisms.1-3 They're made by genetically engineering living cells (also called the cell line)—and a high level of precision is required in the commercial manufacturing process to produce a consistent biological product each time.3-5 The protein produced by the cells will be influenced by individual cell characteristics, the growing environment and the nutrients provided during the manufacturing process.6 The entire process can take from several weeks to months to complete.7

Once the cell line is established, the manufacturing process may be divided into 3 phases: cell culture, recovery, and purification, fill, and finish.7

Read a list of biologics questions answered by Dr. John Petricciani, M.D., an expert in biologic medicines.

Expert Opinion

with Dr. Petricciani

A manufacturer's biological medicine is a unique creation and an identical copy cannot be made by other manufacturers.

Review the Q&A on issues concerning biological medicines
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  2. Schellekens H. Biosimilar therapeutics—what do we need to consider? NDT Plus. 2009;2(suppl 1):i27-i36.
  3. Zhang J. Mammalian cell culture for biopharmaceutical production. In: Baltz RH, Davies JE, Demain AL, eds. Manual of Industrial Microbiology and Biotechnology, Third Edition. Washington, DC: American Society of Microbiology; 2010:157-178.
  4. Sekhon BS, Saluja V. Biosimilars: an overview. Biosimilars. 2011;1(1):1-11.
  5. Wurm FM. Production of recombinant protein therapeutics in cultivated mammalian cells. Nat Biotechnol. 2004;22(11):1393-1398.
  6. Palomares LA, Estrada-Mondaca S, Ramirez OT. Production of recombinant proteins: challenges and solutions. In: Balbas P, Lorence A, eds. Methods in Molecular Biology, Vol. 267: Recombinant Gene Expression: Reviews and Protocols, Second Edition. Totowa, NJ: Humana Press Inc.; 2004:15-51.
  7. Hora M. Manufacturing fundamentals for biopharmaceuticals. In: Jameel F, Hershenson S, eds. Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals. Hoboken, NJ: John Wiley & Sons, Inc.; 2010:589-604.
  8. Walsh G. The drug manufacturing process. Biopharmaceuticals: Biochemistry and Biotechnology, Second Edition. Hoboken, NJ: John Wiley & Sons; 2003:93-187.
  9. Schmidt F-R. From gene to product: the advantage of integrative biotechnology. In: Gad SC, ed. Handbook of Pharmaceutical Biotechnology. Hoboken, NJ: John Wiley & Sons; 2007:1-52.
  10. Liu HF, Ma J, Winter C, Bayer R. Recovery and purification process development for monoclonal antibody production. mAbs. 2010;2(5):480-499.