GEN-MKT-18-7897-A
Jul 20, 2018 | Biopharma, Blogs | 0 comments
Launching the best possible product in the shortest time possible is key for pharmaceutical companies like you. As you know, nearly every process throughout the biologics development cycle requires an immense amount of analytical characterization; get these processes right and significantly reduce time-to-market.
This blog explores a wide range of biologics characterizations, including intact and subunit protein analysis, to help you address your challenges. For more details, fill out the form on your right to download the full Biotherapeutic Analytical Characterization eBook.
Safeguarding Biotherapeutic Product QualityThe ability to routinely and accurately measure intact and subunit protein mass is a critical step in demonstrating the quality and stability of biologics. Using the appropriate combination analytical methods and techniques can result in significant time and cost savings during product development, obtaining regulatory approval and scaling-up manufacturing.
But biotherapeutics are inherently complex and these large class protein biologics, such as monoclonal antibodies (mAb), are significantly more difficult to characterize than small molecules. Liquid Chromatography-Mass Spectrometry (LC-MS) and Capillary Electrophoresis Electrospray Ionization-Mass Spectrometry (CESI-MS) have become recognized techniques for biotherapeutic characterization, offering the resolution, sensitivity, and speed to deliver better results and improve lab productivity.
The Complete Range from SCIEXSCIEX has a range of next-generation technology with the mass range and dynamic range needed to simultaneously detect major and minor isoforms in your intact biotherapeutic. The easy, point-and-click interface of SCIEX OS on the X500B QTOF system makes setup rapid and simple. Or dig deeper into your biotherapeutic products with the high-performance TripleTOF® 6600 System. Our BioPharmaView™ Software balances power and simplicity to bring routine, fast and accurate intact and subunit analysis by mass spectrometry to all laboratories1.
We demonstrate the pure performance, robustness, and stability of our solutions in the Biotherapeutic Analytical Characterization eBook, packed with a range of tech notes and solutions guides, covering:
If you want to accelerate the biologics development cycle and reduce your time-to-market with fast, accurate, and robust intact and subunit mass analysis, fill out the form on your right to download the Biotherapeutic Analytical Characterization eBook.
1https://www.technologynetworks.com/biopharma/articles/mass-spectrometry-in-biopharmaceutical-discovery-303219
It is no secret that (bio)pharmaceutical research and development is complex, both scientific and regulatory processes. Here is an overview of just some of the ways SCIEX is working to support these challenges.
In a recent webinar, available on demand, scientists Luiza Chrojan and Ryan Hylands from Pharmaron, provided insights into the deployment of capillary gel electrophoresis (CGE) within cell and gene therapy. Luiza and Ryan shared purity data on plasmids used for adeno-associated virus (AAV) manufacturing and data on AAV genome integrity, viral protein (VP) purity and VP ratios using the BioPhase 8800 system.
Last year, Technology Networks hosted two webinars that featured groundbreaking research utilizing SWATH DIA (data-independent acquisition) for exposomics and metabolomics. Researchers Dr. Vinicius Verri Hernandes from the University of Vienna and Dr. Cristina Balcells from Imperial College London (ICL) demonstrated how a DIA approach can be successfully implemented in small molecule analysis using the ZenoTOF 7600 system. Their innovative approaches highlight the potential of SWATH DIA to enhance the detection and analysis of chemical exposures and metabolites, paving the way for new insights into environmental health and disease mechanisms.
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