Susan Haigney

Industry experts discuss best practices for certificates of analysis.

A thorough understanding of both regulatory requirements and study challenges can help develop and validate the appropriate methods for a bioanalytical study program.

It is important to understand regulatory requirements and study challenges to develop and validate the appropriate methods for a bioanalytical study program at the clinical stage.

Automation of pharmaceutical packaging saves costs and time, say contract packagers.

The complex nature of biologics creates challenges for GMPs in sterile manufacturing, and the EU’s Annex 1 is making an impact.

CDMOs offer expertise and customization options for sponsors of orphan drugs.

Outsourcing partners are ready to fill the market need for greater cell therapies capacities.

Establishing a quality culture from the top of an organization down to each and every employee ensures a safe and effective product, and saves costs.

The booming cell therapy market has created a need for capacity that outsourcing partners are ready to fill.

Performing corrective action and preventive action (CAPA) activities is often necessary to investigate a manufacturing deviation and prevent it from reoccurring. BioPharm International asked Joe O’Gorman, head of Global Operations at LZ Lifescience, a Cognizant Company, about the role technology plays in performing CAPAs.