Biosimilar manufacturing

Getting effective treatments to you and your patients.

Biosimilar manufacture is a complex, multistep process, carefully designed and closely monitored to ensure the end result is a high-quality product.1 For each biosimilar, an individualized manufacturing method, cell culture, purification process and system of analytical checks is developed.1

Unlike generic drugs, biologic manufacturing involves mammalian and microbial cell cultures which do not follow the exact science of chemical synthesis.Along with the desired biosimilar product, several undesired variants and other process impurities are generated.2 It is therefore important that impurities are constantly checked for and removed using multistep purification processes.1

Our biosimilar process

At Fresenius Kabi, our biosimilars are manufactured in accordance with high quality standards. With production sites and compounding centers across the globe, we leverage a robust supply chain to secure access to life-changing treatments for more patients who suffer from debilitating diseases.

Our biosimilars are manufactured using the following steps in order to produce a high-quality final product:

  • The chosen cell line is expanded in large bioreactors, in conditions optimized for protein production3,4
  • The synthesized biologic is isolated and purified, removing any unwanted impurities3,4
  • The harvested protein is analyzed for uniformity in its 3D structure and potency3

After the manufacturing system has been developed, clinical and non-clinical studies that compare the biosimilar with the reference product can take place.3,4

References:

  1. Kabir ER, et al. The breakthrough of biosimilars: A twist in the narrative of biological therapy. Biomolecules. 2019;9(9):410.
  2. Vulto AG, et al. The process defines the product: what really matters in biosimilar design and production? Rheumatology (Oxford). 2017;56(suppl_4):iv14-iv29.
  3. Gupta SK, et al. http://www.bioprocessintl.com/manufacturing/biosimilars/opportunities-challenges-biosimilar-development. Published 2017. Accessed May 5, 2021.
  4. Al-Sabbagh A, et al. Development of biosimilars. Semin Arthritis Rheum. 2016; 45(5 suppl):S11–S18.
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Looking for more information?

If you would like to know more about Fresenius Kabi and our unique approach to biosimilars, please get in touch.

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