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.
Should Regulation of Combination Products Become More Centralized in Europe?
May 2nd 2013While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.
Using Thermal Ink-Jet Printing Technology to Produce Pharmaceutical Cocrystals
May 2nd 2013Cocrystals are used to improve the performance of APIs that have non-ideal physiochemical properties by cocrystallizing the API with a second compound that modulates the API to provide a way to improve a drug's bioavailability, stability, and processability.
Understanding ICH Q11—FDA's Guidance on the Development and Manufacture of Drug Substances
May 2nd 2013The author provides a review of FDA's guidance document, Guidance for Industry: Q11 Development and Manufacture of Drug Substances, and its relation to the International Conference on Harmonization's Q11 document and its application to the industry.
Big Pharma's Manufacturing Investments in Biologics
May 1st 2013Despite overall manufacturing rationalization in the pharmaceutical/biopharmaceutical industry, the large pharmaceutical companies continue to invest in biologic-based manufacturing. The author provides an update in recent investment activity among the pharmaceutical majors in biologic-drug substance, vaccine, and parenteral drug manufacturing.