The Power of Biologics

Revolutionizing treatments for patients with serious illnesses.

Biologics, sometimes referred to as large-molecule drugs, are protein-based therapeutics that are produced using unique cell lines and are manufactured from natural resources such as human and animal cells, yeast, and bacteria.1,2

Unlike smallmolecule drugs and generics that are manufactured via pure chemical synthesis, biologics undergo several post-translational modifications when manufactured in living cells. They are often 200 to 1,000 times the size of a small molecule or chemical drug and are far more complex. Whereas generics require approximately 50 quality assurance tests as part of the manufacturing process, biologics require approximately 250 tests to ensure potency, purity, and quality.2-4

Biologics are also highly sensitive to temperature and pH, making them more difficult to characterize and produce on a large scale. Even minor alterations in growth conditions may lead to changes in cell behavior and differences in the structure, stability, and other quality aspects of the end product. Any of these differences have the potential to affect the treatment’s safety, efficacy, and shelf life, and to increase the risk of an unwanted immune response.2

 

Amgen’s Heritage in Developing Biologics

Fu-Kuen Lin, a research scientist at Amgen, was the first to clone a gene for a complex biologic, erythropoietin, in 1983. Amgen and Lin received the 1995 Discoverers Award from Pharmaceutical Research and Manufacturers of America for the development of the first man-made injectable version of erythropoietin.5,6

Since the development of recombinant erythropoietin, Amgen has continued to develop innovative biologic medicines that have changed the way we treat cancer, rheumatoid arthritis, osteoporosis, and other serious illnesses. Other biologic medicines include vaccines, blood components, insulin, and monoclonal antibodies (mAbs), all of which have been instrumental in treating millions of patients worldwide.

Comparison of Molecular Mass of Small-Molecule (Chemical) Drugs Versus Large Biologics7-13

Ave=average; DA=Daltons; EPO=erythropoietin;
G-CSF=granulocyte colony-stimulating factor; HGH=human growth hormone; mAbs=monoclonal antibodies.


Cancer

Biotechnology has contributed to significant advances in cancer treatment, including hormone therapies, biologics, and targeted therapies such as monoclonal antibodies (mAbs), that have revolutionized oncology supportive care for immune-compromised patients on chemotherapy.14

Inflammation

With the advent of biologics, treatment of rheumatoid arthritis (RA) has transformed from managing symptoms to aiming for disease remission by inhibiting specifically targeted biochemical pathways of inflammation.15

References:

  1. Conner J, Wuchterl D, Lopez M, et al. The biomanufacturing of biotechnology products. In: Shimasaki C, ed. Biotechnology Entrepreneurship: Starting, Managing, and Leading Biotech Companies. Waltham, MA: Academic Press; 2014:351-385.
  2. Lybecker KM. The biologics revolution in the production of drugs. https://www.fraserinstitute.org/studies/biologics-revolution-in-the-production-of-drugs. Fraser Institute. Accessed November 23, 2016.
  3. Alten R, Cronstein BN. Clinical trial development for biosimilars. Semin Arthritis Rheum. 2015;44:S2-S8.
  4. EuropaBio. Guide to biological medicines: A focus on biosimilar medicines. European Medicines Agency. 2005.
  5. Amgen 2004 Annual Report. Amgen Inc. http://library.corporate-‌ir.net/library/61/616/61656/items/‌143940‌/‌amgn2004AR.pdf. Accessed November 23, 2016.
  6. PhRMA Discoverers Award. PhRMA (Pharmaceutical Research and Manufacturers of America); 2011.
  7. Aspirin Prescribing Information, Bayer.
  8. Lovenox (enoxaparin sodium injection) Prescribing Information, Sanofi-Aventis.
  9. Humalog (insulin lispro injection) Prescribing Information, Eli Lilly.
  10. Neupogen® (filgrastim) Prescribing Information, Amgen.
  11. Humatrope® [somatropin (rDNA ORIGIN)] Prescribing Information, Eli Lilly.
  12. Epogen® (epoetin alfa) Prescribing Information, Amgen.
  13. Taltz (ixekizumab) Prescribing Information, Eli Lilly.
  14. Scott AM, Allison JP, Wolchok JD. Monoclonal antibodies in cancer therapy. Cancer Immun. 2012;12:14-21.
  15. Keyser FD. Choice of biologic therapy for patients with rheumatoid arthritis: the infection perspective. Curr Rheumatol Rev. 2011;7:77-87.