Characterization of Biopharmaceuticals
Mass spectrometry can be used, in conjunction with protein and carbohydrate chemistry, to solve a variety of structural problems ranging from de novo protein sequencing, to the characterization of recombinant proteins, including vaccine and antibody products. Particular emphasis is placed on the identification of post-translational modifications, such as glycosylation. We are proud to offer our clients a complete analytical characterization package tailored to your needs in order to fulfil regulatory requirements. We have vast experience in the analysis of biopharmaceutical products to comply with ICH guidelines, particularly ICH Q6B and the concept of a “well-characterized” or “specified” molecule.
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ICH Q6B requires |
M-Scan provides |
ICH Q6B requires |
M-Scan provides |
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We have applied the MS-Mapping technique routinely to the characterization of recombinant protein and glycoprotein products. In addition, this analysis can be extended to examine microheterogeneity at both the N- and C-termini and to define the location of disulfide bridges - areas which are difficult to analyze using conventional techniques. A full analytical package can be performed, or individual analyses selected depending on client needs - we are happy to guide and advise.
Studies are performed on molecules at all stages of the drug development pipeline including: Discovery/Research, Process and Analytical Development, Production Quality Control through to Regulatory Approval and Batch Release Testing.
For over 28 years, we have provided a professional, confidential commercial analytical service for structure determination, which has proved invaluable to our wide range of clients, many of whom include our data in submissions to regulatory authorities.
