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 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.

Alternative Cleaning Validation Methods for Biologics

With new tests showing NDMA levels increase under normal storage conditions, FDA calls for removal of ranitidine products from the market.

FDA Removes Ranitidine Products from Market

Understanding formulation properties early in development can prevent some costly issues later on.


A Little Thought Goes a Long Way in Tableting

The company has developed mathematical algorithms that generate simple cell-count data from a few days of culture.

Asymmetrex’s New Algorithms Offer Low Cost Rapid Cell Counting

The new NAB Nanosep device provides increased binding capacity.

Pall’s Nanosep Centrifugal Device Offers High Nucleic Acid Binding Capacity

The acquisition will expand Nexelis’ immunology testing expertise.

Nexelis to Acquire ImmunXperts, an Immunogenicity and Immune-Oncology Testing Lab

As compounds become more complex in nature and biological ingredients are more widely used, stability testing approaches must follow suit and provide flexibility for developers.
