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Analytical Sciences Group Laboratory
Case Study
Biotechnology Capability Research and Development
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ASG Case Studies:
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| New analytical technologies are required to meet the complex emerging needs of product development for biopharmaceuticals. ASG has taken the opportunity to develop capabilities in this area through working closely with clients engaged in the process R&D and manufacture of oligonucleotide and recombinant protein therapeutics
ASG has undertaken R&D programmes designed to establish high level capabilities and methodologies for the characterisation of these complex, macromolecular products and their associated impurities; critical requirements for the demonstration of patient safety. This work has proved very successful and resultant services are now employed by several clients to support process R&D, to trouble-shoot problems and to contribute to batch release analysis where complex instrumentation and methodologies are required.
Typical key ASG laboratory techniques used in these programmes are ESI-MS, MALDI-MS, LC-MS, LC-MS-MS, ICP-MS and NMR. Programme development requires advanced skills in separations, spectrometry, biochemistry and biochemical procedures, with a diverse range of enzymatic and chemical procedures for protein or oligonucleotide sequencing.
A recent exemplification of capability was a detailed study of low level impurities in a late clinical phase biotechnology product. The task was complicated by ion exchange separation methods dependent on high salt concentrations. Following optimisation of desalting procedures, mass spectrometry data was obtained which met the objectives of this complex study.
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