Bioconjugates, such as antibody drug conjugates (ADCs), conjugate vaccines, or PEGylated proteins, are complex molecules composed of different chemical entities. Their comprehensive characterization requires analytical methods that are specifically adjusted to the chemical moieties the bioconjugates are composed of.
Chemical polymers, such as polyethylene glycols and block-copolymers, are molecules comprising different functional groups (ethers, amines, etc.). The meaningful analytical characterization of such polymers is dependent on methods that take the structural features of the polymer into account.
We provide services for the physico-chemical characterization and potency testing of both bioconjugates and polymers, as well as analyses of these compounds in biological samples.
Our analytical services comprise
- Method transfer from client to celares or vice versa
- Development of analytical methods
- Qualification and validation of analytical methods
- Evaluation of key starting materials or excipients for drug manufacturing
- Comparability exercise for biosimilar products
- Stability testing according to ICH guidelines
- Characterization of reference products, main compound and impurities
- Analytics in biological samples
- Routine testing of samples
- Release testing for drug substance (DS) and drug product (DP) according to GMP
Our services are tailored to each product and for each client.
Please contact us for any questions, requests or comments.