A unique in house expertise in analytical development for biologics
To provide the highest quality, our manufacturing services are supported by in-house analytical capabilities and expertise.
Our analytical team is uniquely proficient at developing analytical methods for the characterization of a diversity of molecules from conventional monoclonal antibodies to complex proteins – including recombinant protein, fusion proteins.
An extensive and strong range of analytical services
Our experienced analytical team applies a broad range of methods to support process development and product release. Our laboratory is fitted out with state-of-the-art equipment to enable us to provide advanced characterization of your product.
The routine activities of our analytical and quality control teams include:
- Raw material testing and environmental monitoring,
- Method development and validation,
- Analytical support for USP and DSP IPC (in process control),
- DS testing and release for all clinical, phases and up to commercialization,
- DS and DP Stability studies.
Our specific analytical package for MAbs/proteins includes a range of methods among which:
- MAB and total protein quantification (affinity chromatography and OD280),
- Purity by capillary electrophoresis (cGE) and size exclusion chromatography,
- Charge variants by cIEF and CEX-HPLC,
- Process related impurities: protein A, HCP and DNA,
- Custom biological activity by ligand binding assay (ELISA),
- Endotoxins and bioburden assessment,
- Excipient quantification (i.e. polysorbates by HPLC-ELSD),
- Mass spectrometry and peptide mapping for structural characterization and investigational purposes,
- Glycan analysis by HPLC-HILIC-FLD.
Our analytical team has the expertise to handle method transfer, method development and validation to have the most robust process to ensure the success of the cGMP manufacturing of your drug substance and drug product.