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.
Catalent Biologics Opens New Single-Use Biomanufacturing Facility in Madison
April 26th 2013Catalent Pharma Solutions, a provider of drug and biologic development services, delivery technologies and supply solutions, has officially opened a new biomanufacturing center of excellence in Madison. The facility, which was constructed in response to customer demand, is expected to quadruple Catalent's current biologics manufacturing capacity and extensively utilise single-use technology for greater flexibility and efficiency. It will allow the company to extend its offerings in the biologics sector while enhancing the efficiency and output of its proprietary GPEx cell line engineering technology as well as other mammalian cell lines.