Biologic medicines are manufactured using living cells that have been engineered to produce therapeutic proteins in large quantities. These proteins are very sensitive to their conditions of synthesis and handling, and a series of critical culturing and purification steps is required to produce a consistent, high-quality active ingredient.1


The Steps to Manufacture a Biologic
CELL CULTURE RECOVERY & PURIFICATION FORMULATION TO DISTRIBUTION
1. Process Line Development
2. Cell Expansion
3. Cell Culture
4.  Harvest
5.  Purification (multiple steps)
6.  Virus Inactivation/Removal
7.  Filling 
8.  Finishing
9.  Packaging & Storage
10.  Quality Assurance & Characterization
11.  Stability Testing

Complexities of Manufacturing Biosimilars
The complexities of manufacturing biologic medicines also apply to biosimilars, which are approved on the basis of demonstrating similar quality, safety and efficacy to originator biologic medicines.

In attempting to copy the originator product, biosimilar manufacturers must independently design their own cell cultures and production steps, which are considered proprietary knowledge.2 It is therefore impossible for biosimilar manufacturers to precisely replicate the manufacturing process of the original biologic or the active ingredient of the protein product.3 This creates a unique relationship between a biologic's manufacturing process and the final product approved by regulators.

The defined process of a biosimilar is important to ensuring a high level of similarity to a reference product. This is one of the many ways Amgen is leveraging its more than 35 years of experience to help in the development of high-quality biosimilars.

Good Manufacturing Practice for Large Molecules

Good Manufacturing Practice for Large Molecules

Glossary