Piramal Pharma Solutions' UK ADC Manufacturing Facility Receives Updated MHRA GMP Certification
核心洞察
Piramal Pharma Solutions' Grangemouth facility in Scotland has received updated three-year MHRA GMP certificates covering all operations in its specialized Helix building.
The facility serves as Piramal's dedicated antibody-drug conjugate development and manufacturing site, supporting both clinical and commercial drug substance production.
The certification strengthens the facility's regulatory standing and supports its role in the ADCelerate program, which aims to accelerate bioconjugate therapy development from R&D to GMP manufacturing.
Piramal Pharma Solutions announced that its bioconjugates (搜索) facility in Grangemouth, Scotland, has received updated good manufacturing practice (GMP) certificates from the UK's Medicines and Healthcare products Regulatory Agency (MHRA). The certificates, valid for three years, were granted following the site's submission of an MHRA GMP compliance report and completion of a successful desktop inspection.
The updated certificates encompass all activities within the facility's Helix building, which specializes in clinical and commercial drug substance manufacture and testing, along with supporting warehouse and laboratory areas. As Piramal Pharma Solutions' dedicated antibody-drug conjugate (ADC) development and manufacturing facility, Grangemouth offers comprehensive solutions for bioconjugates (搜索), from process development to scale-up.
Strategic Role in ADC Development
The Grangemouth site plays a critical role in Piramal's ADCelerate program, which streamlines the path from R&D to GMP production to bring lifesaving bioconjugate therapies to patients in the clinic faster. The facility supports both clinical and commercial drug substance production and represents a key component of the company's specialized ADC manufacturing capabilities.
"This achievement underscores the Grangemouth facility's dedication to upholding the highest standards of quality across their operations," said Peter DeYoung, CEO of Piramal Global Pharma. "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."
Regulatory Track Record
The updated MHRA GMP certificates reflect an ongoing commitment to excellence at Grangemouth, as evidenced by an exceptional regulatory track record. The facility maintains a strong inspection history with multiple international regulatory bodies, including the US FDA (搜索), Japan's PMDA, ANVISA, Turkey's health ministry, and South Korea's FDA.
Together with the site's existing GMP certificates, the updated certificates ensure Grangemouth is well-equipped to support client programs and regulatory filings. The certification strengthens the facility's regulatory standing and enhances its ability to serve pharmaceutical partners developing bioconjugate therapies.
The Grangemouth facility operates as part of Piramal Pharma Solutions' global CDMO network, which spans facilities across North America, Europe, and Asia, offering end-to-end development and manufacturing solutions across the drug life cycle.