Biosimilar manufacturing 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.¹ 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 medicines 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 production^3,4
• The synthesized biologic is isolated and purified, removing any unwanted impurities^3,4
• The harvested protein is analyzed for uniformity in its 3D structure and potency³