Piramal Healthcare UK Ltd., Piramal Pharma Solutions, Earls Road, Grangemouth, Stirlingshire, Scotland, UK, FK3 8XG
Piramal’s Grangemouth facility offers development, clinical and commercial scale manufacturing of bioconjugates including Antibody Drug Conjugates (ADCs) since 2004. The site provides full process & analytical development services to support proof-of-concept & toxicology studies with commercial manufacturing of ADCs since 2012. The site has successfully cleared US FDA, UK MHRA, Japan PMDA and Brazil ANVISA inspections.
Piramal’s Grangemouth facility delivers end-to-end solutions right from early-stage preclinical and toxicology batch preparation to commercial manufacturing. Owing to our decades of experience and flexible approach, we deliver tailored solutions to accelerate IND-enabling studies
We have experience in the development of major ADC platforms, non-cytotoxics, and a broad range of protein conjugates. We offer expertise in preclinical proof-of-concept (POC) studies, formulation studies, conjugation chemistry optimization, optimization of purification techniques and process characterization studies. Our technology transfer teams enable seamless transfer from clinical to commercial scale.
The Grangemouth facility supports the scale-up of projects from clinical through to the commercial stage. A history of more than 1000 ADC batches, 6 projects of more than 1 kg batch size, and GMP manufacturing of 35 distinct bio-conjugates highlights our manufacturing experience
Our analytical scientists develop analytical test methods customized to your specific molecule. We provide phase-appropriate analytical methods supported with high-quality and transparent data to enable regulatory approvals with leading agencies around the world
Piramal’s Grangemouth facility delivers end-to-end solutions right from early-stage preclinical and toxicology batch preparation to commercial manufacturing. Owing to our decades of experience and flexible approach, we deliver tailored solutions to accelerate IND-enabling studies
We have experience in the development of major ADC platforms, non-cytotoxics, and a broad range of protein conjugates. We offer expertise in preclinical proof-of-concept (POC) studies, formulation studies, conjugation chemistry optimization, optimization of purification techniques and process characterization studies. Our technology transfer teams enable seamless transfer from clinical to commercial scale.
The Grangemouth facility supports the scale-up of projects from clinical through to the commercial stage. A history of more than 1000 ADC batches, 6 projects of more than 1 kg batch size, and GMP manufacturing of 35 distinct bio-conjugates highlights our manufacturing experience
Our analytical scientists develop analytical test methods customized to your specific molecule. We provide phase-appropriate analytical methods supported with high-quality and transparent data to enable regulatory approvals with leading agencies around the world
Our experience in handling projects ranges from the initial toxicology batches to the commercial launches. This facility has delivered over 450 lab-scale, toxicology, and pre-clinical batches using both off-the-shelf as well as proprietary molecules
Grangemouth facility supports scale-up for GMP manufacturing processes, ongoing commercialization and follow-up activities. Our multi-product manufacturing facility is characterized by specialized or single-use product-contact manufacturing components
The site is capable of handling compounds with OEL < 0.01 ug/m3. We have over 18 years of experience with numerous payloads and have delivered 700 GMP batches till date
Our state of the art analytical laboratories provide a wide array of analytical methods ranging from small molecule analysis to cell killing assays and ELISA development
As a partner of choice for ADC contract manufacturing, we recognize that speed matters. Our branded offering, ADCelerate, is an integrated ADC solution that accelerates timelines for developing the initial clinical supply of both drug substance and drug product
Building on our history as pioneers in ADC contract development and manufacturing, Piramal has become a trusted service provider for our clients with hundreds of unique ADCs developed and more than a thousand ADC batches manufactured.
We offer full conjugation services, from milligram-scale “Proof of Concept” (POC) studies to process development and scale-up. Integrated services provided include development and manufacturing of payload-linker, mAbs, and fill-finish.
Our vast experience with different types of cytotoxic payloads such as auristatins, maytansines, duocarmycins etc. includes manufacturing of 1000+ ADC batches and 500+ GMP batches.
Our quality management systems are compliant with ICH Q7 guidelines. A Quality Assurance officer is assigned with each project to provide continuity through product lifecycle. Our promise of good quality is reinforced by a customer-centric and patient-centric approach.
Grangemouth site is established by Scottish Dye
First ADC was manufactured
Business was purchased by Piramal from Avecia Pharmaceuticals
Expansion of capacity by 70% with commissioning of a new state-of-the-art facility
