Piramal’s bioconjugates UK facility gets updated MHRA GMP certificates
India-headquartered Piramal Pharma Solutions, a global contract development and manufacturing organization (CDMO) and part of Piramal Pharma Ltd., announced that its Grangemouth, UK facility received updated Medicines and Healthcare products Regulatory Agency (MHRA) GMP certificates following a compliance report and desktop inspection.
“These certificates encompass all activities within the facility’s Helix building, which specializes in clinical and commercial drug substance manufacture and testing,” according to the announcement. “They also extend to the building’s supporting warehouse and laboratory areas.”
A dedicated antibody-drug conjugate (ADC) development and manufacturing facility, Grangemouth provides comprehensive solutions for bioconjugates, from process development to scale-up, Piramal said. The site also plays a vital role in the ADCelerate program, which the company contends streamlines the process from R&D to GMP production to bring bioconjugate therapies quicker to patients in the clinic faster.
The updated MHRA GMP certificates for the Grangemouth facility follow successful inspections by the U.S. FDA, Japan’s Pharmaceuticals and Medical Devices Agency, Brazilian Health Regulatory Agency, the Turkish Ministry of Health, and South Korean FDA.
“This achievement underscores the Grangemouth facility’s dedication to upholding the highest standards of quality across their operations,” Peter DeYoung, CEO of Piramal Global Pharma, said in a statement. “With these updated MHRA GMP certificates, the site can continue supporting our partners in this critical area of drug development, helping them bring bioconjugate therapies to patients in need with the utmost precision, efficiency, and reliability.”
In late June, Piramal Pharma Solutions broke ground as part of its $90 million investment to expand two U.S. facilities. The expansion of Piramal’s facilities in Lexington, Kentucky, and Riverview, Michigan, will add commercial-scale manufacturing capabilities as well as enhance the capacity and efficiency of each site. Both sites are essential components of the CDMO’s integrated ADC offering, ADCelerate.