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
The Echo® MS+ system is a novel platform for Acoustic Ejection Mass Spectrometry (AEMS) and combines the speed of acoustic sampling with the selectivity of mass spectrometry. This platform has been designed for high throughput analysis of small and large molecules. The technology combines Acoustic Droplet Ejection (ADE), an Open Port Interface (OPI) and could be coupled with the SCIEX Triple Quad 6500+ system or the ZenoTOF 7600 system.
The Echo® MS+ system comprises of an open-port interface (OPI) and acoustic droplet ejection (ADE) module which could be coupled with a mass spectrometer. The mass spectrometer could either be a SCIEX Triple Quad 6500+ system or the ZenoTOF 7600 system. This non-liquid chromatography based; high-throughput screening platform enables rapid analysis of compounds at speeds of up to 1 sample/second.
The ability to consistently achieve reproducible results on many complex samples across multiple days is critical to a routine clinical laboratory. Laboratories relying on analytical instrumentation require stability and robustness to perform a variety of screening and confirmatory assays with confidence. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) has become the preferred analytical method in the clinical laboratory to reliably perform clinical testing as it provides best-in-class performance and reliability for the most challenging assays. LC-MS/MS offers the required levels of sensitivity and specificity for the detection and quantitation of molecules from complex biological samples, helping laboratories deliver highly accurate data for a variety of clinically relevant analytes across a wide range of assays.
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