Susan Haigney

In addition to a new interim president, the company is opening new microbial capacity at its San Antonio facility and has plans to construct a commercial-scale facility in Manhattan, Kan.

The bio/pharma outsourcing industry continues to be integral in the development and manufacture of medicines.

Manufacturing biopharmaceuticals in an aging facility may create quality issues such as equipment breakdown and contamination risks.

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.