Riverview
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Riverview, USA

Piramal Pharma Solutions, 18655 Krause St, Riverview, MI 48193, USA

  • Detroit Metropolitan Wayne County Airport (DTW), Detroit, MI
  • Driving Distance: 14 miles ( 25 min)

Drug Substance Development & Manufacturing

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.

Featured Services

API Development Services

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.

API Development Services

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Clinical and Commercial Manufacturing

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.

Clinical and Commercial Manufacturing

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Development and Manufacturing of HPAPI

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

Development and Manufacturing of HPAPI

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Analytical Method Development and Validation

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.

Analytical Method Development and Validation

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API Development Services

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API Development Services

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.

Clinical and Commercial Manufacturing

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Clinical and Commercial Manufacturing

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.

Development and Manufacturing of HPAPI

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Development and Manufacturing of HPAPI

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

Analytical Method Development and Validation

expand_more
Analytical Method Development and Validation

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.

Site Capabilities

  • Process Development

  • Manufacturing Capability and Capacity

  • HPAPI Capabilities

  • Controlled Substances

  • ADCelerate: Integrated Solutions

Process Development

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Process Development

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).

Manufacturing Capability and Capacity

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Manufacturing Capability and Capacity

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.

HPAPI Capabilities

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HPAPI Capabilities

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.

Controlled Substances

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Controlled Substances

The site can deal with Schedule III, IV and V controlled substances.

ADCelerate: Integrated Solutions

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ADCelerate: Integrated Solutions

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.

Quality

Quality

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.

Experience with Fast-track Approvals

Experience with Fast-track Approvals

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.

End-to-end Integrated Solutions

End-to-end Integrated Solutions

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.

Full-range of HPAPI Services

Full-range of HPAPI Services

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.

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Outstanding customer service and highly skilled technical and quality teams. Projects are efficiently organized and completed on time.

Pharma, US

The team is always customer-focused and willing to help. That is the biggest differentiator for me for Piramal versus other CMOs. We'll always have product issues come up; it's how the team handles the problems that separates the good from the bad. Piramal is the best at this part.

Pharma, Japan

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Riverview Facility : Timeline of Milestones

2024
1962

Founded by Wayne State University professors Arthur Ash and Calvin Stevens

2024
2016

Acquired by Piramal

2024
2023

PRIME-1 opening

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Peptide Fragments

Turbhe, India

Building Block

Piramal Discovery Services, India

+1 More Option
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Payload/Linker

Riverview, USA

Monoclonal Antibody

Hyderabad, India

Conjugation

Grangemouth, UK

Sterile Fill Finish

Lexington, USA

Intermediate Development & Manufacturing

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HPAPI Development & Manufacturing

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High Potency Fill Finish

Lexington, USA

Potent OSD Formulation

Sellersville, USA

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Discovery & Route Scouting

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Intermediate Development & Manufacturing

Ennore, India

HPAPI Development & Manufacturing

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Injectable Development & Manufacturing

Lexington, USA

Discovery & Route Scouting

Piramal Discovery Services, India

Intermediate Development & Manufacturing

Ennore, India

API Development & Manufacturing

Digwal, India

API Development & Manufacturing

Aurora, Canada

API Development & Manufacturing

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Discovery & Route Scouting

Piramal Discovery Services, India

Intermediate Development & Manufacturing

Ennore, India

API Development & Manufacturing

Digwal, India

API Development & Manufacturing

Aurora, Canada

API Development & Manufacturing

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+2 More Option
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Pre-Formulation & Formulation Development

PPDS, India

OSD Development, Manufacturing and Packaging

Sellersville, USA

OSD Development, Manufacturing and Packaging

Pithampur, India

API & OSD Development, Manufacturing & Packaging

Morpeth, UK

+2 More Option
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