Intertek ASG Laboratory, Manchester, UK

CMC Analytical Support:

Technology for Development of Biopharmaceuticals

Intertek ASG is able to provide a range of services in support of regulatory submissions for the development of biopharmaceuticals, specifically with regards to analytical method development and validation packages for CMC sections in IND (USA) or CTA (Europe) submissions. In addition to characterization of the main protein sequence and structure, molecular species studied for quantitation include a broad range of fermentation ingredients, bi-products from the fermentation process and bio-processing aids. Examples of these include antibiotics, protein denaturing agents, initiators for protein expression systems, protein folding catalysts and formulation aids for the final product. Methods are developed to ICH Q6B guidelines.

Specific molecules studied by Intertek ASG include the antibiotics streptomycin, kanamycin and tobramycin, and a wide range of processing aids including DTT, IPTG, DCC, various amino acids and urea.

Principle Analytical Technologies available for protein characterization to ICH Q6B guidelines include:

• Molecular Weight Information
• Peptide Mapping by Mass Spectrometry
• SDS-PAGE
• Amino Acid Analysis
• Isoelectric Focusing
• Size Exclusion Chromatography
• N- and C-Terminal Sequencing
• Disulfide (-S-S-) Bridge Analysis
• Glycosylation Analysis

Analytical Technologies applied to other constituents from bioprocessing include:
   

• HPLC and LC-MS
• GC and GC-MS
• NMR
• Ion Chromatography
• A range of wet chemistry and other techniques

 
Intertek ASG can also provide cGMP QC testing and cGMP stability testing programmes.

asg.nwtc@intertek.com

+44 (0) 161 721 5247

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