Piramal Pharma Solutions’ UK bioconjugates site gets updated MHRA GMP certificates

Piramal Pharma said on Wednesday its bioconjugates facility in Grangemouth, Scotland, has received updated good manufacturing practice (GMP) certificates from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).The company said the certificates remain valid for three years. They cover all activities at the site’s Helix building, including its warehouse and laboratory operations. They were granted after the MHRA reviewed a GMP compliance report and completed a desktop inspection.

The Grangemouth site, Piramal’s dedicated antibody-drug conjugate (ADC) development and manufacturing facility, supports clinical and commercial drug substance production and is a key part of the company’s ADCelerate programme, which aims to speed the transition from R&D to GMP manufacturing.

Piramal said the updated certificates, along with existing approvals, strengthen the facility’s regulatory standing and support client programmes and filings.“With these updated MHRA GMP certificates, the site can continue supporting our partners… with precision, efficiency, and reliability,” said Peter DeYoung, CEO of Piramal Global Pharma.

The company added that the site has a strong inspection track record with regulators including the US FDA, Japan’s PMDA, ANVISA, Turkey’s health ministry and South Korea’s FDA.