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

PathoQuest will apply its experience in viral safety testing and quality control of biologics for mitigating the risk of adventitious agent contamination in biopharmaceutical manufacturing.

PathoQuest Joins CAACB Consortium as Viral Safety Expert

This article provides an overview of the key risks that can be associated with the use of secondary reference standards (RS) and illustrates scientific challenges associated with transitioning from pharmacopeial RS to secondary RS. 

The Value of Pharmacopeial Reference Standards

Emily Johnston is a senior analytics engineer with Seeq.

Sharing process insights across the stages of drug development improves tech transfer.

Optimizing Tech Transfer with Advanced Analytics 

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

Common approaches to analyze elemental impurities for compliance with regulatory requirements are robust but still have some limitations.

Approaching Elemental Impurity Analysis

Advanced i-Series liquid chromatographs from Shimadzu provide users with the ability to analyze a large number of samples and re-process data while working remotely.

Liquid Chromatographs for Remote Work

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

Having a clear and detailed understanding of exactly what a biomolecule entails is essential for therapeutics development.

Protein Characterization Can Support Regulatory Submission

Nexelis’ recent acquisition of GSK’s Marburg, Germany-based vaccines clinical bioanalytical laboratory expands its bioanalytical capabilities.

Nexelis Expands Bioanalytical Services with Bioanalytical Lab Acquisition

The £500,000 (US$686,294)-investment in mass spectrometry support will accelerate biologics development and approval.

Almac Invests in Expanding Global Biologics Testing Solutions

Jared Auclair is associate dean, Professional Programs and Graduate Affairs, and director, Biopharmaceutical Analysis Training Lab, Northeastern University.

Lori Stansberry is marketing manager, Pharma & BioPharma, Thermo Fisher Scientific.

Vendors are finding ways to address the increasingly complex analytical challenges in the biopharmaceutical industry to further biotherapeutic development.

Is Collaboration the Key to Accelerating Biotherapeutic Development?

Using rDNA technology to synthesize production of proteins and peptide hormones, the biotech startup has achieved synthetic production of insulin, potentially lowering insulin cost by 30%. 