Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.

Emerging Therapies Drive Analytical Advancements

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.

Analyzing Exabytes

Effective analytics will eliminate failures, deviations, and non-conformances.

Designing Phase-Appropriate CMC Analytical Programs

August 01, 2019

A one-size-fits-all strategy is not the best approach for the development of a chemistry, manufacturing, and controls program.

De-risking Biologics Development Through Advanced Mass Spectrometry Approaches

August 01, 2019

Using advanced HDX-MS and native MS techniques can improve the identification of potentially successful biologic drugs and de-risk CMC and clinical designs.

Best Practices for Selecting a Service Provider

August 01, 2019

Key considerations when searching for an analytical service provider include workflow, hardware, and regulatory support.

From Data to Information

August 01, 2019

Making siloed data accessible across functions and to contract partners is the first step to facilitating continuous improvement and enabling use of artificial intelligence in manufacturing.

GLPs: Better Data Access Needed to Improve Compliance

August 01, 2019

Tools help lab scientists capture and use more data and work to ensure data integrity.

Use of AI is Growing in Pharma

August 01, 2019

Bio/pharmaceutical companies are adopting artificial intelligence for discovery, development, risk assessment, safety monitoring, and manufacturing.

Cambrex Announces Expansion of Scottish Solid-Form Screening Facility

July 30, 2019

Cambrex has revealed that it is expanding its solid form screening and crystallization process development facility in Edinburgh, Scotland.

Putting Endotoxins to the Test

July 02, 2019

This article discusses current methods of endotoxin testing, its importance to the industry, sustainability issues relating to the process, and best practices.

Can Bioprocessing Achieve Digital Transformation?

July 02, 2019

Automation promises to connect biomanufacturing processes more closely, and to bring greater efficiency to the manufacturing floor.

FDA Announces Draft Guidance for Bioanalytical Method Validation

July 01, 2019

FDA is collecting public comments on a draft guidance for bioanalytical method validation developed by ICH.