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As regulatory guidance has evolved, changes in CCIT testing have also become apparent. In this article, possible CCIT strategy approaches are outlined.


Container Closure Integrity Testing of Finished Sterile Injectable Product

GNA Biosolutions has completed its latest round of Series C financing in which it raised US$13.5 million.

GNA Biosolutions Closes Latest Financing Round Backed by US/EU Consortium

The Tridex Protein Analyzer from IDEX offers the ability to directly measure protein titer from a bioreactor in real time.

Protein Analyzer Offers Ability to Measure Protein Titer Directly from Bioreactor

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

A risk-based approach to CMC enables drug sponsors to focus on clinical and manufacturing development paths.

Balancing CMC Priorities

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

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


Analysis and Purification: Instrumental to BioPharma

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.

Analytical Method Development