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Rapid Quality Control of Biopharmaceutical Products
| Type: | Application |
Application Note |
Expression Proteomics, Gen. Pharma & Chemistry |
| Number: | Technology |
ET-18 |
UHR-TOF |
| Year | Products |
2010 |
maXis |
| Author | |
Laura Main, Wolfgang Jabs, Arndt Asperger, Dirk Wunderlich, Marcus Macht, Pierre-Olivier Schmit; Bruker Daltonik, Bremen, Germany |
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| Reference | |
ET-18, #269416 |
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Abstract |
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Biopharmaceutical therapies, such as monoclonal antibodies, are set to replace traditional small molecule blockbuster drugs over the next few years. Biologics are usually very large, complex molecules. A biologic is manufactured in a living system usually by recombinant technology. These living systems can be very sensitive to minor changes in the manufacturing process. Small process differences may significantly alter the final biologic product, by introducing modifications, which may adversely affect the safety and efficacy of the drug. Strict quality control, of each biopharmaceutical batch is essential to ensure reproducibility between batches and to achieve regulatory approval. QC of each biologic batch can rapidly be performed by non-technical experts using electrospray mass spectrometry (ESI-MS). The Bruker maXis™ ESI-UHR-TOF-MS, provides high-resolution, high-mass accuracy (confident low ppm) data at full sensitivity. The combination of high mass accuracy and resolution allows rapid detection of modifications, whilst high sensitivity assists detection of low level impurities within the biologic batch. In this application note we will describe an open access method for the rapid QC characterization of biotherapeutic drugs. |
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Related Products |
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maXis 4G |
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