Monoclonal antibodies (mAbs) are highly complex biomolecules easily affected by changes in the biopharmaceutical manufacturing process. Something as simple as a temperature fluctuation can produce a change in higher order structure (HOS) that renders the mAb less active or inactive.
Whether your mAb is an original product or a biosimilar, our comparability studies are designed to ensure robust and reproducible mAb production. Testing services performed meet GMP guidelines and include:
- Comparability between a biosimilar and an original product
- Comparability between different production facilities or different production lots