Biopharmaceuticals are drugs produced using biotechnology. They tend to be proteins or nucleic acids used for therapeutic or in vivo diagnostic purposes and are produced by means other than direct extraction from a native (non-engineered) biological source.
Ensuring the identity, purity, safety and quality of your biopharmaceutical is critical to it's success.
Offering a portfolio of analytical methods ranging from DNA quantification, chromatographic methods to state of the art mass spectrometry based detection techniues we can help you navigate the challenges.
We believe in supporting you through the biologic development, production and quality assurance cycle by providing first class analysis, expert consultancy advice and training.
- Host cell DNA and protein contamination detection using Real-time PCR and ELISA
- Protein and impurity profiling by LC-MS-MS, LC-TOF-MS and capillary electrophoresis
- Glycosylation profiling
- Leachable and extractables using LC-MS-MS, GC-MS and NMR
- Aggregation studies
- Stability storage to ICH guidelines
- Consultancy advice and support
Join our Bioanalytical Characterisation Linkedin group