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

Topic

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Articles

Integration of new modeling and analytical tools with flow chemistry are notable trends.  

Efficiency Demands Drive Advances in API Labs

Binodh DeSilva, PhD, is AAPS past-president.

Efforts strive to harmonize bioanalytical method validation for non-clinical and clinical studies.

AAPS Traces the Path to ICH M10

Christopher Burgess, PhD, is managing director, Burgess Analytical Consultancy Limited, Barnard Castle, Co Durham, UK.

This article applies the basics of stability, performance, and capability to modern process performance and capability indices.

Process Stability, Performance, and Capability; What is the Difference?

Amber Lowry is an associate editor at UBM plc.

Experts weigh in on up-to-date analytical procedures for the lot release testing of small-molecule pharmaceuticals.

Lot Release Testing Analytics for Small-Molecule Drugs

The LCMS-9030 quadrupole time-of-flight (TOF) liquid chromatograph mass spectrometer from Shimadzu is a researchgrade mass spectrometer suited to deliver high-resolution, accurate-mass detection with fast data acquisition rates.

Mass Spectrometer for Analyzing Complex Samples

The companies collaborated to launch a new cell-based profiling service for biochemical assay.

Reaction Biology and Promega Partner on Bioassay Tool

New software tools by Tecan, a provider of automated laboratory instruments and solutions, complement each other to enhance process monitoring of its liquid-handling platforms.

New Software Tools Enhance Real-Time Process Monitoring in Labs

Agnes Shanley is senior editor of Pharmaceutical Technology.

The European Medicines Agency’s detection of a second nitrosamine in a sartan API is driving a deeper dive into tetrazole chemistry; root-cause investigations will now include not only valsartan and losartan, but candesartan, irbesartan, and olmesartan.

After Valsartan Recalls, Regulators Grapple with Nitrosamine Contamination in APIs

Research by Thermo Fisher Scientific and LumaCyte suggests that LumaCyte's Radiance instrument offers the ability to rapidly analyze viral vaccines to speed development and production and ensure their effectiveness.

New Analytical Instrument Could Change Vaccine Development Through Faster Viral Detection

The companies have partnered to launch Conjugated Polymer Nanoparticle (CPN) products for use in molecular imaging and R&D applications.