There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.

Biologics Quality Control: The Growing Need for Accessible Proteomics

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.

Emerging Therapies Drive Analytical Advancements

Effective analytics will eliminate failures, deviations, and non-conformances.

 Analyzing Exabytes

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Articles

The agency has approved Nucala (mepolizumab) to treat Eosinophilic Granulomatosis with Polyangiitis (EGPA) to GlaxoSmithKline. This indication is the first FDA-approved therapy specifically to treat EGPA.

FDA Approves First Drug for EGPA

SGS has introduced a Sanger sequencing service at its Glasgow, United Kingdom, laboratory to support genetic stability testing and perform identity testing on cell banks, plasmids, and viral seeds/vectors.

SGS Adds GMP DNA Sequencing Capabilities at Glasgow Facility

The new 30,000-L, $150-million biologics manufacturing facility in Wuxi, China, quintuples the company’s existing manufacturing capability.

WuXi Biologics Starts Up Large-Scale, Single-Use Biomanufacturing Facility

Gilead Sciences will acquire Cell Design Labs to further cell-therapy research and development efforts.

Gilead Sciences and Kite to Acquire Cell Design Labs

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

Stakeholders Comment on FDA Draft Guidance for Evaluating Biosimilarity

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Amid business and regulatory uncertainty, bio/pharma experts reveal opinions on salary, recognition, and training.

What are the Ingredients for Bio/Pharma Career Advancement?

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Medherant has developed an improved instrument for testing drug release from transdermal patches.

Advances in Transdermal Patch Drug Delivery and Measurement

SÃ¡ndor KemÃ©ny* is an emeritus professor at Budapest University of Technology and Economics, Faculty of Chemical Technology and Biotechnology, Department of Chemical and Environmental Process Engineering.

In Part I of this article series, the authors discussed the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies. In Part II, the by-time-point method and the multivariate control chart method are investigated, and improved approaches are suggested. The method is illustrated using real data sets.

Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements—Part II: By-Time-Point and Multivariate Control Chart

The Hiden ExQ quantitative gas analyzer is a mass spectrometer system providing continuous on-line analysis of dynamic gas streams at pressures from sub-atmospheric up to 30 bar. 

Gas Analyzer for TGA/TA Analytics

The InMotion Karl Fischer (KF) Oven Autosampler from Mettler Toledo is suited for KF titration and comes in two models, InMotion Flex and InMotion Pro, and allows up to 26 samples to be analyzed on a 25-centimeter platform.