Piramal is a global leader in delivering customer centric solutions in the world of Antibody Drug Conjugates (ADCs) and Bioconjugates to global pharma and biopharma companies alike. Our world class facilities in UK and US, backed by a highly experienced team, offer integrated services, from conjugation to Clinical and Commercial ADC GMP Batch Manufacturing and Fill/ Finish.
We offer range of contract development and manufacturing services for fully integrated ADC solutions to customers in every corner of the globe.
The ADCelerate program has been designed as a rapid approach to delivering ADC drug substance and drug product suitable for Phase I trials, enabling accelerated product delivery to clinic patients. From project initiation to GMP drug product in just 12 months, maintaining uncompromised quality.
Comprehensive support provided for development and manufacturing of Payload-linker, mAb, ADC Drug substance, and Fill-finish.
Piramal provides a comprehensive suite of services spanning from conjugation development, through clinical trials supply, to commercial manufacturing, ensuring a seamless end-to-end solution for our customer’s needs.
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 offers development and manufacturing services for large molecules through our associate company Yapan Bio. Based in Hyderabad, India, Yapan Bio has a proven track record in the successful development and manufacturing of various large molecules. Yapan specializes in process development, scale-up, and GMP-compliant manufacturing of vaccines and biologics, including high-containment product classes (up to BSL-2+), recombinant vaccines, viral vector-based vaccines, gene therapies, monoclonal antibodies, therapeutic proteins, and other complex biologics for Phase I/II human clinical trials.
Riverview is recognized as a world-class facility renowned for its expertise in drug substance manufacturing, with over 60 years of experience in delivering high-potency APIs (HPAPIs). The site has excelled in advancing several HPAPIs from early development to commercial manufacture, solidifying its position as a global leader in API and HPAPI development, as well as GMP manufacturing for complex NCEs.
The site has been fully inspected by numerous regulatory agencies, including USFDA, Health Canada, PMDA Japan, COFEPRIS Mexico, MFDS Korea, TGA Australia, and the Russian Ministry of Health.
Piramal’s Lexington, KY site specializes in the formulation development and manufacturing of Sterile Injectables, offering sterile compounding, fill/finish, and lyophilization capabilities. The facility is equipped with in-house analytical, microbiological, formulation development, and manufacturing services, spanning from preclinical to clinical and commercial stages.
The site possesses extensive experience and proficiency across the complexity scale ranging from simple liquid, lyophilized (both Aqueous & Co-solvent based) formulations to complex drugs products such as Liposomal, Nano-emulsions, Nanoparticle suspensions and Anti-body Drug Conjugates (ADCs). Major regulatory accreditations include USFDA, PMDA, TFDA and Saudi Food and Drug Authority.
ADCelerate is Piramal Pharma Solutions’ rapid approach to delivering Phase-Iappropriate ADC drug substance and drug product, so that you can accelerate the delivery of your product to patients in the clinic. From project initiation to GMP drug product in as little as 12 months, with no compromising on quality.
