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There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.
The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.
Effective analytics will eliminate failures, deviations, and non-conformances.
June 01, 2021
PPD has opened its new multipurpose clinical research laboratory in Suzhou, China, which offers bioanalytical, biomarker, and vaccine sciences services for China and the global market.
May 16, 2021
The sensitivity of droplet digital PCR helps manufacturers detect Mycoplasma contamination in AAV-based gene therapy products.
May 03, 2021
A shortage of pipette tips has been attributed to several factors, including the COVID-19 pandemic.
This article introduces a practical approach to determining the best estimate for probability of passing uniformity of dosage units (content uniformity) using probability vs. lot coverage charts and tables constructed using simulated probability and lot coverage (LC1) data.
May 02, 2021
Mass spectrometry and automation are growing in importance for protein characterization, but further improvements are still needed.
April 02, 2021
A well-chosen replication strategy can effectively reduce the uncertainty for an analytical method, enabling appropriate decisions regarding pharmaceutical quality.
Despite its importance in drug development, dissolution testing still has some limitations, but advances in automation and real-time monitoring are producing promising results.
April 01, 2021
Raman spectroscopy delivers real time, non-destructive process insights for critical process parameters to monitor pharmaceutical manufacturing.
March 19, 2021
The move to continuous manufacturing and Pharma 4.0 is resulting in a more data-driven approach to bio/pharma development. Enabling this approach are innovative data systems that can help users improve product quality while facilitating audit-trail review. First used with chromatography, they are now being applied to mass spectrometry.
March 16, 2021