January 17th 2025
Production is set to take place at Samsung Biologics’ Songdo, South Korea, site, and the agreement will run through December 2030, subject to change.
The evolution of therapeutic modalities drives the adoption of single-use technologies.
Managing Technology Transfer: Developing a Complete CMC Package for an In-Licensed Product
August 1st 2011The authors share their approach and experience working in complex, multicompany environments for in-licensed products to develop successful chemistry, manufacturing, and controls packages for managing outsourcing partnerships.
Evaluating QbD's Impact on the Outsourced Relationship
August 1st 2011An Industry Roundtable Moderated by Patricia Van Arnum and Rich Whitworh. Contract service and technology providers share their perspectives on the influence of quality by design in the expectations between sponsor companies and outsourcing providers.
DHS Revises Tiering Assignments Under Chemical-Site Security Measures
July 21st 2011The DHS announced it has revised tiering assignments for several chemical facilities covered under DHS's Chemical Facility Anti-Terrorism Standards program, which requires chemical companies to develop and implement specific security plans for their facilities.