OR WAIT null SECS
November 01, 2023
USP offers strategies to minimize residual impurities in downstream processing.
October 11, 2023
The construction of Gritgen’s GMP facility strictly adheres to the global current GMP (CGMP) standards and complies with the regulatory guidelines of authoritative agencies including the National Medical Products Administration (NMPA), FDA, and the European Medicines Agency (EMA).
October 05, 2023
The program will allow sponsors of certain CBER and/or CDER-regulated products more frequent communication with FDA staff.
September 20, 2023
Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the importance of continuous manufacturing for the future.
Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the highlights of her ICH Q13 session that she wants others to be aware of.
September 19, 2023
Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses how advanced manufacturing technology can improve things such as cost and efficiency.
September 18, 2023
Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the barriers to the development of continuous manufacturing processes after implementing ICH Q13.
September 15, 2023
Scientists are leveraging ddPCR technology to get an accurate read on viral titer and vector copy number.
September 13, 2023
Rentschler Biopharma’s ATMP business can now offer its full range of services for the clinical supply of AAV, including bioprocess and analytical development through to cGMP manufacturing at the Stevenage facility in the UK.
September 08, 2023
The new policy will require trading partners to supply, accept, and manage all documentation of product and ownership of prescription drugs electronically.