Piramal Pharma Solutions, 18655 Krause St, Riverview, MI 48193, USA
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.
Our comprehensive development services encompass process research, development, optimization, and scale-up, along with capabilities such as analytical method development, impurity identification, and solid-state characterization. Dedicated HPAPI labs and payload linker spaces enhance our capacity for specialized projects.
Our manufacturing services encompass non-clinical tox batch production to cGMP manufacturing for clinical trials, process validation (PPQ), and commercial API manufacturing. We can manufacture APIs for a wide range of therapeutic areas, ranging from gram scale to 250kg batches.
The Riverview site has extensive experience in safely delivering high potency APIs (HPAPIs) and has advanced several HPAPIs from early development to commercial manufacture. With state-of-the-art high-potency manufacturing suites, we ensure precise handling of compounds with OELs as low as 10ng/m
Our cutting-edge analytical labs offer a comprehensive suite of services tailored to meet diverse analytical chemistry needs. From method development and qualification/validation to specification development and material testing, we ensure rigorous quality control throughout the product lifecycle. Our expertise extends to the qualification of reference samples, stability studies and testing, and forced degradation studies.
Our comprehensive development services encompass process research, development, optimization, and scale-up, along with capabilities such as analytical method development, impurity identification, and solid-state characterization. Dedicated HPAPI labs and payload linker spaces enhance our capacity for specialized projects.
Our manufacturing services encompass non-clinical tox batch production to cGMP manufacturing for clinical trials, process validation (PPQ), and commercial API manufacturing. We can manufacture APIs for a wide range of therapeutic areas, ranging from gram scale to 250kg batches.
The Riverview site has extensive experience in safely delivering high potency APIs (HPAPIs) and has advanced several HPAPIs from early development to commercial manufacture. With state-of-the-art high-potency manufacturing suites, we ensure precise handling of compounds with OELs as low as 10ng/m
Our cutting-edge analytical labs offer a comprehensive suite of services tailored to meet diverse analytical chemistry needs. From method development and qualification/validation to specification development and material testing, we ensure rigorous quality control throughout the product lifecycle. Our expertise extends to the qualification of reference samples, stability studies and testing, and forced degradation studies.
We provide an array of services, including process/route selection, isolation and synthesis of impurities, spike and purge studies, process safety studies and process modelling studies using Dynochem®. We also offer particle size reduction along with solid-state characterization (XRPD, DSC, TGA).
The site is equipped with glass-lined and Hastelloy reactors up to 4000L, with a temperature range of -10°C to 20°C. Our product isolation capabilities encompass extraction, distillation, and filtration techniques, alongside hydrogenation capabilities up to 60 psi on scales up to 200L. Our kilo lab can handle cryogenic conditions down to -70°C up to 100L scale.
As a global leader in HPAPI services, Riverview offers full range of high potency API capabilities. We have a dedicated space for HPAPIs, equipped with both disposable and permanent isolators capable of handling compounds with OEL >0.01µg/m3. With reactors volumes up to 50L, we can deliver batches up to 2kg. The facility also offers in-house milling of HPAPIs using Conical and Hammer Mills.
The site can deal with Schedule III, IV and V controlled substances.
The Riverview facility forms a critical component of our integrated ADC solutions offering, ADCelerate. Drawing upon the years of experience and state-of-the-art equipment available at the site, we seamlessly integrate cytotoxic payload and linker services from the Riverview site with our other offerings (mAbs, conjugation and fill-finish) to deliver your final ADC drug product in as little as 12 months.
The Riverview site has an exceptional record of FDA manufacturing approvals for innovator APIs, having commercialized 18 NCE APIs till date. Our promise of good quality is reinforced by a customer-centric and patient-centric approach.
With a legacy of more than 60 years in API development and manufacturing, the Riverview facility is experienced in all major therapeutic areas. The facility also has significant experience with Fast-Track Approvals, Breakthrough Status and Orphan Diseases.
With Piramal’s global network of facilities, clients can seamlessly integrate API production at Riverview with KSM/RSM production and formulation development/manufacturing at other sites. Riverview is also a constituent of integrated ADC solutions, ADCelerate, enabling delivery of the final ADC drug product from project initiation in as little as 12 months.
The Riverview facility has the equipment and expertise to provide end-to-end solutions for HPAPI development and manufacturing. With dedicated suites and isolator-based handling, we ensure safety and quality at all stages of the development process.
Founded by Wayne State University professors Arthur Ash and Calvin Stevens
Acquired by Piramal
PRIME-1 opening
