Biopharmaceuticals are an innovative, continually expanding segment of the pharmaceuticals industry. Therapeutic proteins are subject to authorisation standards distinct from classical low-molecular or chemically synthesised active agents. This is because proteins present complex structures which cannot be adequately defined by physicochemical parameters. Developments in the area of instrumental analytics have given rise to increased requirements with regard to the characterisation of active agents and quality control.
Protein specification
The authorisation and control authorities are promoting the concept of good protein specification! At AZ Biopharm, we offer both individual analyses and complete protein characterisation, always implemented and documented in line with GMP:
- Generation of characterisation data for marketing authorisation dossiers
- Testing of product stability and approval of therapeutic proteins
- Methods: SDS-PAGE and blotting, CE, SEC, IEX, MS
Glycoprotein analysis
Post-translational modifications are enormously relevant to the effectiveness of therapeutic proteins. Glycosylation is the most frequent and complex form of protein modification. With this in mind, in accordance with the applicable ICHQ6B guidelines, AZ Biopharm offers a structural glycosylation analysis as an integral part of the comprehensive product characterisation of biopharmaceuticals:
- Characterisation of the glycosylation status
- Locating the glycosylation site
- Clarification of glycan structures
- Methods: HILIC, MS