Process and Scaling

Computerized Systems Validation

September 02, 2015

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for automated systems.

Continued Process Verification Key to Lifecycle Control and Continuous Improvement

August 18, 2015

Regulatory officials and industry scientists participated in a CMC Strategy Forum sponsored by CASSS in July 2015.

3M Launches Production-Scale Sizes of its Upstream Purifiers

July 14, 2015

The new sizes follow the 2014 launch of the company’s fully disposable purifier.

Getting Scientific About Cleaning Validation

July 01, 2015

An ISPE guidance document, four years in the making, brings risk-based thinking, statistics, and Lean Six Sigma to cleaning validation.

Collaborative Success Strategies for Biopharm Companies

July 01, 2015

PharmTech Multimedia

Barry Holtz, Principal, at Holtz Biopharma Consulting, and Klyo Collaborative, spoke with Pharmaceutical Technology about collaborative success strategies for biopharm companies.

Natrix Introduces New Disposable mAb Purification Column

June 29, 2015

The new column features Natrix’s signature macroporous hydrogel.

Microbiologists Contribute to a Quality Culture

June 17, 2015

Equipment and Processing Report

Presenters at IVT's Microbiology Week discussed best practices and recent guidance publications for microbial control in sterile and non-sterile pharmaceutical processes.