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Microbial Analytical Development & Qualification

Cobra provides full analytical support for customers, abiding by analytical reference standards, including assay transfer, the development of cell based potency assays, assay transfer services, and expert product characterisation.
 
Cobra offers 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 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 carry out oligosaccharide profiling, glycosylation site characterisation whilst looking at post-translational modifications.
 
Physicochemical properties can be examined via molecular weight or size with isoform pattern and electrophoretic profiling too.
 
Our Quality Assurance (QA) team provide 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 are completed can be undertaken as required.

Other Microbial Protein Services...

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