The Mutual Recognition Agreement will allow FDA and EU inspectors to recognize each other’s work and avoid the duplication of drug inspections. / read more /
The agency’s CHMP recommended conditional marketing authorization for the hormone replacement therapy for the treatment of chronic hypoparathyroidism. / read more /
Sanofi and Lonza formed a joint venture to build and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland. / read more /
An example of a new cold chain temperature-controlled shipping technology is Cocoon, which was commercialized in November 2016 and designed for use with pallet-sized shippers. / read more /
Laboratory tests can determine critical cleaning parameters for passivation treatments used to prevent rouge on GMP stainless-steel equipment. / read more /
Currently, pharmaceutical manufacturers are said to waste $25 billion on supply chain inefficiencies. Technology offers a way to achieve transparency and results. / read more /
Pharmaceutical Technology Outsourcing Guide provides details behind recent partnerships, strategies for selecting an appropriate CDMO/CMO, and quality by design factors for outsourced operations. / Click here /
Quality issues can appear at any stage of the bio/pharmaceutical development and manufacturing supply chain. Drug companies must monitor raw materials, suppliers, contract service providers, facilities, manufacturing processes, and production workers. In this e-book, the editors examine current quality issues, and how the industry is addressing quality challenges throughout the supply chain.
