Piramal Pharma Solutions’ Grangemouth facility in the UK has successfully obtained updated Good Manufacturing Practice (GMP) certificates from the Medicines and Healthcare products Regulatory Agency (MHRA). These certificates cover all activities within the Helix building, including clinical and commercial drug substance manufacture and testing, as well as supporting warehouse and laboratory areas. The updated certificates, combined with the site’s existing GMP certificates, ensure that Grangemouth is well-equipped to support its clients’ programs and regulatory filings.
As a dedicated antibody-drug conjugate (ADC) development and manufacturing facility, Grangemouth offers comprehensive solutions for bioconjugates, from process development to scale-up. The site plays a critical role in the ADCelerate program, which streamlines the path from R&D to GMP production, bringing lifesaving bioconjugate therapies to patients faster. The achievement underscores the facility’s dedication to upholding the highest standards of quality across its operations.
Piramal Pharma Solutions is a global company that offers end-to-end development and manufacturing solutions across the drug life cycle. With a network of facilities in North America, Europe, and Asia, the company provides a range of services, including drug discovery solutions, process and pharmaceutical development services, clinical trial supplies, and commercial supply of APIs and finished dosage forms. Piramal also offers specialized services, such as the development and manufacture of highly potent APIs, antibody-drug conjugations, and biologics, including vaccines and gene therapies.
The company’s CEO, Peter DeYoung, stated that the updated MHRA GMP certificates demonstrate the Grangemouth facility’s commitment to quality and its ability to support partners in bringing bioconjugate therapies to patients in need. With its comprehensive range of services and global network of facilities, Piramal Pharma Solutions is well-positioned to support the development and manufacture of complex therapies, including ADCs and biologics. The company’s expertise and capabilities make it an attractive partner for pharmaceutical companies looking to bring new therapies to market.