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Mammalian Analytical Development & Qualification

Cobra provides full analytical support for our customers, including assay transfer, the development of cell-based potency assays, and expert product characterisation.
 
We offer comprehensive packages for the physicochemical characterisation of protein products, and where appropriate more than one analytical procedure employing different analytical principles will be applied. The characterisation packages are adapted to the requirements of the product in order to comply with ICH guidelines especially for antibodies and biosimilars.
 
We also support protein characterisation for IND (investigational New Drug) applications and BLAs (Biological License Applications).
 
Structural characterisation and confirmation can be examined as well as amino acid composition, peptide mapping and disulphide bridge analysis. 

For carbohydrate structures we can carry out analysis of
monosaccharide composition, sialic acid content and also perform oligosaccharide profiling and glycosylation site characterisation whilst looking at post-translational modifications.
 
Physicochemical properties can be examined via molecular weight or size, alongside isoform pattern and electrophoretic profiling.
 
Our Quality Assurance (QA) team provides Quality Control (QC) release testing of Drug Substance & Drug Product.
 
Cleaning validation and raw materials testing is undertaken to ensure the highest standards are maintained for all of our customers’ programmes.
 
Shipping studies to determine stability for product transportation including variations in temperature, humidity, light and oxygen levels can be undertaken as required.

Other Mammalian Protein Services...

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