Next Generation Biologics Manufacturing | Amgen Biosimilars



Our process is what defines us

Fundamental principles of biosimilar manufacturing

Fundamental principles of biosimilar manufacturing1-3

Engineering a biosimilar

On the basis of a reference biologic’s critical quality attributes (CQAs), a biosimilar is engineered to be highly similar in terms of host cell proteins, product attributes, variants, process impurities, and stability profile.

Characterization and comparative studies

High similarity in analytical and pharmacokinetic/pharmacodynamic (PK/PD) data between the reference biologic and the biosimilar indicates a lower risk of clinical differences.

Quality standards in manufacturing

Rigorous quality standards throughout the manufacturing process and extensive risk assessments to promote quality.

At Amgen, we excel at the highly specialized, iterative process of developing monoclonal antibodies in vitro, scaling up the optimal cell line, time and again, in large-scale bioreactors, and checking and rechecking for batch-to-batch consistency.4,5

End-to-end biologics experts: our process4

cell group cell group

Medicines born of living cells

Screening process

Screening process
An extensive screening process is used, consisting of the following steps: 4,6-8
Cell culture4
  • Process line development
  • Cell expansion
Recovery and purification
  • Harvest
  • Purification (multiple steps)
  • Virus inactivation/removal
Formulation to distribution
  • Filling
  • Finishing
  • Packaging and storage
  • Quality assurance and characterization
  • Stability testing

Our biologic medicines are manufactured using living cells engineered to produce therapeutic proteins in large quantities. Those cells are very sensitive to conditions produced during their synthesis and handling, and a series of culturing and purification steps are required to produce a consistent, quality active ingredient.9


The complexities of biosimilar manufacturing

The complexities of biosimilar manufacturing

The complexities of biosimilar manufacturing
When manufacturing a biosimilar, only the reference product’s amino acid sequence is known. From there, the biosimilar candidate requires considerable preclinical optimization.2

All of the complexities of manufacturing innovator biologics apply to biosimilar medicines as well. But biosimilar creation also has its own set of intricacies.

References: 1. Kozlowski S. US FDA perspectives on biosimilar biological products. Presented at: 2014 Biotechnology Technology Summit; June 13, 2014; Rockville, MD. Accessed October 29, 2019. 2. US Food and Drug Administration. Guidance for industry: quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product. Accessed October 29, 2019. 3. US Food and Drug Administration. Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product. Accessed October 29, 2019. 4. Desanvicente-Celis Z, Gomez-Lopez A, Anaya JM. Similar biotherapeutic products: overview and reflections. Immunotherapy. 2012;4:1841-1857. 5. Ramanan S, Grampp G. Drift, evolution, and divergence in biologics and biosimilars manufacturing. BioDrugs. 2014;28:363-372. 6. Bee JS, Randolph TW, Carpenter JF, Bishop SM, Dimitrova MN. Effects of surfaces and leachables on the stability of biopharmaceuticals. J Pharma Sci. 2011;100:4158-4170. 7. 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. 8. Blauvelt A, Cohen AD, Puig L, Vender R, van der Walt J, Wu JJ. Biosimilars for psoriasis: preclinical analytical assessment to determine similarity. Br J Dermatol. 2016;174:282-286. 9. Lybecker KM. The biologics revolution in the production of drugs. Fraser Institute. Accessed October 29, 2019. 10. Dranitsaris G, Amir E, Dorward K. Biosimilars of biological drug therapies. Drugs. 2011;71:1527-1536. 11. Liu HF, Ma J, Winter C, Bayer R. Recovery and purification process development for monoclonal antibody production. mAbs. 2010;2:480-499. 12. Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol. 2008;19:411-419. 13. Roger SD. Biosimilars: how similar or dissimilar are they? Nephrology. 2006;11:341-346. 14. Hesse F, Wagner R. Developments and improvements in the manufacturing of human therapeutics with mammalian cell cultures. Trends Biotechnol. 2000;18:173-180.