In general, protein structure depends on the manufacturing process. Proteins derived from prokaryotic (bacterial) cells can be improperly folded, lacking glycosylation and are not secreted.

Eukaryotic cells can fold proteins properly, but they can introduce variations in carbohydrate structure and other post-translational modifications.

The follow-on Drug (Biosimilar) manufacturer does not have access to the originator's molecular clone and original cell bank, nor to the exact cell culture and purification process. Low levels of impurities, such as host cell proteins, and/or breakdown products that are not observed in the original drug may have serious health implications. This has created a concern that copies of biologics might perform differently from the marketed version of the drug.

New versions of biologics are not authorized in the US or the European Union through the simplified procedures allowed for small molecule generics. Special approval procedures have been authorized for certain protein drugs, based on the demonstration of "comparability" of the "similar" product to an approved product.

BTK Consultants have been involved in the development of new biologics by recombinant DNA technology since the early days of the industry. They have the development, analytical characterization, assay development, quality and regulatory skills needed to effectively bring your drug to market.