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

Articles

The new chromatography columns provide enhanced separation for high order aggregates and macromolecules.

Tosoh Bioscience Introduces TSKgel UP-SW Aggregate UHPLC/HPLC Columns

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

Ensuring the quality of data in process monitoring and control systems starts in process development phases. 

Building Data Quality In Generates Quality Data Out

A variety of assays should be used to detect bacterial, fungal, and viral contaminants in the human source cells used for cell therapies.

Detecting Contamination in Cell Therapies

The extension of the company’s product offerings to include the anti-certolizumab pegol antibodies offers critical reagents for the development of assays for TNF alpha inhibitor biologics and their biosimilars.

Bio-Rad Launches Anti-Certolizumab Pegol Antibodies

Agnes Shanley is senior editor of Pharmaceutical Technology.

Discovery of carcinogenic nitrosamines in three of the world’s most widely prescribed drugs is driving efforts to better detect, control and prevent their generation in APIs and finished drug products.


Contamination Drives a More Concerted Approach to Genotoxins

A comprehensive turnkey system based on LabVantage’s laboratory information management system platform allows laboratories to implement COVID-19 biobanking, testing, and research.

New Biobanking LIMS Accelerator for Managing COVID-19 Testing

The company has expanded capabilities for aggregate analytics to include dynamic light scattering.

Protagen Protein Services Expands Capabilities for Aggregate Analytics

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

Characterizing and controlling protein aggregation is vital to ensure safety and efficacy of a biopharmaceutical product. In this interview, important aspects of protein aggregation and the tools available to address this issue are discussed.


Keeping Aggregation Under Control

Richard Durham is chemistry, manufacturing and control (CMC) quality liaison with Metrics Corp.

Jerry Neal is senior analytical chemist with Metrics Corp. 

Jerry Mizell is director of analytical services at Metrics Corp. 

Matt Casteen is team leader with Metrics Corp. 

This case study highlights analytical instrumentation and techniques that were used to identify an unknown impurity detected during routine release testing of a topical gel drug product.

Identifying the Structure of an Unknown Impurity in a Topical Gel

Because conventional cleaning methods can risk product loss, biopharmaceutical manufacturers are often reluctant to use PDE/ADE limits to validate cleaning processes.