OR WAIT null SECS
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 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 03, 2023
FDA is anticipating how AI may advance manufacturing and improve supply chain security.
Recent research and perspectives shed light on an opportunity to better connect risk and knowledge through improved integration of systems.
September 02, 2023
Audits and inspections both assure that requirements have been fulfilled and whether documented proof is available, says Siegfried Schmitt, vice president, Technical at Parexel.
August 18, 2023
The assessment aims to determine whether valproate use in men could lead to neurodevelopmental disorders in their children.
August 11, 2023
The guidance can help both applicants and manufacturers limit the mutagenic and carcinogenic potential of NDSRIs.
August 02, 2023
An intelligent drug development paradigm can enable small pharma to implement an effective early drug development approach.
August 01, 2023
In this episode, David Tisi and Reenal Gandhi provide expert insights into advances and innovations changing the drug dosage form landscape.
July 20, 2023
The document’s recommendations outline what studies and reports are required for changes to cell and gene therapy manufacturing.