These certificates encompass all activities within the facility's Helix building, which specializes in clinical and commercial drug substance manufacture and testing. They also extend to the building's supporting warehouse and laboratory areas.
As per the release, together with the site's existing GMP certificates, the updated certificates ensure Grangemouth is well-equipped to support its clients' programs and regulatory filings.
As Piramal Pharma Solutions' dedicated antibody-drug conjugate (ADC) development and manufacturing facility, Grangemouth offers comprehensive solutions for bioconjugates, from process development to scale-up. The site also plays a critical role in the ADCelerate program, which streamlines the path from R&D to GMP production to bring lifesaving bioconjugate therapies to patients in the clinic faster.
"This achievement underscores the Grangemouth facility's dedication to upholding the highest standards of quality across their operations," said Peter DeYoung, CEO, 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."
Piramal Pharma Solutions is offering end-to-end development and manufacturing solutions across the drug life cycle. It has a globally integrated network of facilities in North America, Europe, and Asia. The company offers a comprehensive range of services including drug discovery solutions, process and pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. Piramal also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products and services, and potent solid oral drug products. It also offers development and manufacturing services for biologics including vaccines and gene therapies, made possible through Piramal Pharma Limited's associate company, Yapan Bio Private Limited.
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