By allowing developers to bypass comparative efficacy studies when advanced analytics are successful substitutes, the FDA draft guidance avoids one of the most expensive steps, potentially cutting years from timelines and expanding patient access. For developers though, the burden doesn’t disappear; it shifts directly from clinical trials to analytical testing.
CDMS is reshaping the characterization of complex biotherapeutics by enabling precise analysis of large, heterogeneous biomolecular complexes and gene therapy vectors. This article explores how CDMS enhances resolution in quality assessments across biotherapeutic development and structural biology research—surpassing the capabilities of conventional analytical techniques.
Explore how next-generation high-performance liquid chromatography (HPLC) systems are elevating biopharmaceutical analysis. This eBook showcases innovations in size-exclusion chromatography (SEC), method updates, and proven approaches to increase efficiency, consistency, and resolution in the lab.
Application Notebook highlighting Liquid Chromatography techniques commonly used for monitoring Critical Quality Attributes (CQAs) in Bioprocessing Applications
Webinar Date/Time: Thursday, December 11th, 2024 at 11:00 AM EST
Webinar Dates/Times: Session 1 (EU): Wednesday, May 17th, 2023 at 2pm BST | 3pm CEST | 9am EDT Session 2 (NA): Wednesday, May 17th, 2023 at 1pm EDT | 10am PDT | 6pm BST Session 3 (APAC): Thursday, May 18th, 2023 at 12pm JST | 11am CST | 11pm EDT
Read a compelling, detailed Case Study about how an innovation partnership with Waters Corporation enhanced Alcami’s capacity, efficiency, and compliance-readiness for their pharmaceutical manufacturing and analytical services to differentiate their offerings and drive business growth.
Webinar Date/Time: Thu, Mar 9, 2023 11:00 AM EST
Using the BioAccord LC-MS System and an Ambr® 15, we developed an analytical method for rapid mAb glycoform confirmations and mAb purity assessments. This unique method is high throughput capable and has the potential to be a fully automated platform for mid-process intraday monitoring of CQAs.
Wednesday, December 1st, 2021 at 11 am EST | 10 am CST | 8 am PST Learn how to accelerate therapeutic mAbs workflows by automating analysis of critical quality attributes (CQAs) such as Fc glycosylation, oxidation, C-terminal lysine clipping, and glycation.
October 4, 2021 at 3pm BST | 10am EST | 4pm CEST Join global industry and regulatory experts as they discuss current hot topics in extractables and leachables (E&L) testing for pharmaceuticals, biopharmaceuticals and medical devices.
Learn tips for efficient analyses of mAb charge variants, at both the intact and subunit level, using ion-exchange chromatography (IEX) and detection via mass spectrometry (MS). Gain insight on tools and tactics for accurate quantitation and cleaner spectra with less undesired adduct noise or super charging. Live: Wednesday, Dec. 4, 2019 11am EST | 8am PST | 4pm GMT | 5pm CST On demand available after airing until Sept. 10, 2020 Register free
In this webcast, learn about the development of a fast and robust CQA monitoring method based on multi-attribute monitoring principles using a compact, compliance-ready LC-MS system. The presentation will demonstrate how the method can be easily transferred from development to manufacturing through commercial product lifecycle management. Live: Tuesday, Sept. 10, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Sept. 10, 2020 Register free
Published: December 4th 2019 | Updated: