A little flexibility in approach will improve consistency and enable pharma partners to perform to their optimum level. Ahead of her presentation on ‘How to Build a ‘Framework for Managing Your Outsourcing Partner’ at CPhI North America, we spoke with Stephanie Gaulding, executive director of regulatory compliance at Pharmatech Associates
AGC is to expand the production lines of its AGC Wakasa Chemicals subsidiary at the Kaminaka plant in Japan’s Fukui prefecture. The amount involved was not disclosed but the expansion, due to start operation in Q1 2024, will increase AGC Wakasa Chemicals’ manufacturing capacity by 50%, with more potentially to come.
The ongoing race to develop the first effective vaccines for the treatment of COVID-19 continues to generate manufacturing and development agreements between pharmaceutical giants, biotechs and CDMOs.
Most recently, Sterling Pharma Solutions agreed to carry out final purification of drug product for Moleculin Biotech’s WP1122 drug candidate from its site in Cary, North Carolina. Moleculin is about to submit an IND for this to the FDA and wanted a reliable source of supply in the US.
Roger-Marc Nicoud, CEO of Ypso-Facto, looks at the challenges and opportunities for CDMOs in the current crisis*
The current crisis has highlighted the dependence of European and, indeed, North American countries on delocalised production. This is the case for many goods, including APIs and drugs in general.