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

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

Articles

To deal with the complex requirements of biopharmaceuticals, companies need a sophisticated toolbox of analytical and purification techniques.


Analysis and Purification: Instrumental to BioPharma

Machine vision systems have been an integral part of pharma manufacturing and packaging for many years and, with the introduction of stricter safety regulations, are set to become more vital.


Farther Than the Eye Can See

J. Scott Mellors is principal scientist at 908 Devices Inc.

Helen Yan is senior associate scientist at Amgen Inc., One Amgen Center Dr., Thousand Oaks, CA 91320.

Burton Lee is senior associate scientist at Amgen Inc., One Amgen Center Dr., Thousand Oaks, CA 91320. 

Jiemin Bao is scientist at Amgen Inc., One Amgen Center Dr., Thousand Oaks, CA 91320. 

Tawnya Flick is principal scientist at Amgen Inc., One Amgen Center Dr., Thousand Oaks, CA 91320. 

Laura E. Blue is principal scientist at Amgen Inc., One Amgen Center Dr., Thousand Oaks, CA 91320.

The ZipChip CE-ESI interface was evaluated for suitability as a platform approach for quantitation of MIs in API. 

Quantitation of Mutagenic Impurities in APIs Using a Platform Chip-Based CE–MS Method

Protein characterization is a critical part of drug development, but as there are still limitations with available techniques, industry needs to look at technological advances to meet the specific requirements of complex molecule characterization.

Accepting the Challenge of Protein Characterization

Wayland Rushing, PhD, is director, scientific affairs for Eurofins, BioPharma Product Testing.

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

Designing Phase-Appropriate CMC Analytical Programs

Jennifer S. Chadwick, PhD, is director of biologic development at BioAnalytix.

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

De-risking Biologics Development Through Advanced Mass Spectrometry Approaches

Jiawei Chen, PhD, is global strategic marketing manager at SCIEX.

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

Best Practices for Selecting a Service Provider

Agnes Shanley is senior editor of Pharmaceutical Technology.

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.

From Data to Information

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

GLPs: Better Data Access Needed to Improve Compliance

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

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes