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.

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The companies will focus on the rapid development of polymerase chain reaction assays for emerging pathogens and potential health threats, including biological threats.

Roche Expands PCR-Test Portfolio with Completion of Purchase Agreement of TIB Molbiol

Lynn D. Torbeck is an international consultant and trainer specializing in applied statistics and experimental design for pharmaceutical, biopharmaceutical, and medical device research and development, validation, quality control/assurance, and production, 2000 Dempster Plaza, Evanston, IL 60202, tel. 847.424.1314.

Chuck Pheatt is Professor Emeritus with Emporia State University.

The authors introduce the idea of asymmetrical tolerance intervals as an aid in fully assessing product performance relative to product or process requirements.  

Using Tolerance Intervals to Assess Conformance to Requirements

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

Simple, inexpensive real-time analytics are urgently needed for high value products.

Analytics Advances for Optimizing Downstream Processes

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Particle analysis is a critical component of pharmaceutical development, providing assurances of the quality and performance of the final dosage form.

Not a Particle of Doubt

Sartorius is investing €100 million (US$113 million) between 2021 and 2025 to expand capacities for production, innovation, and storage at its French facilities in Aubagne, Cergy, and Lourdes.

Sartorius to Invest in Growing Operations in France

David Smith is CMO manager at Glide Pharmaceutical Technologies Ltd.

Courtney LeBlon, PhD, Director of Technical Operations, Ori Biotech.

Stephen Shapka, PhD, Lead Automation Engineer, Ori Biotech.

Analytical methods need a boost to ensure quality control for cell and gene therapies.

Contamination Control for Cell and Gene Therapies Needs New Analytics

Chris Burgess, PhD, is an analytical scientist at Burgess Analytical Consultancy Limited, ‘Rose Rae,’ The Lendings, Startforth, Barnard Castle, Co Durham, DL12 9AB, UK; Tel: +44 1833 637 446; chris@burgessconsultancy.com; www.burgessconsultancy.co

Different methods to calculate limits for impurities will give different answers. The prediction interval method may be ideal.

From PharmTech: Detecting and Determining Quantitation Limits for Impurities

Researchers from MIT have developed novel nanosensors for the detection of the nucleocapsid and spike protein of the SARS-CoV-2 virus.

New Carbon Nanotube-Based Sensor Can Detect SARS-CoV-2 Proteins 

MilliporeSigma’s new ColorWheel flow cytometry portfolio is designed to create antibodies and dyes analogous to a primary conjugated antibody.

MilliporeSigma Unveils ColorWheel Flow Cytometry Portfolio

Sartorius’ newly redesigned vacuum filtration units are designed to allow for faster and higher-capacity filtration while offering enhanced stability for sample processing.