World-leading multi-product facility for clinical and commercial manufacturing of; antibody drug conjugates (ADCs). Process development. characterisation, optimisation and scale-up expertise supporting successful GMP manufacturing.

#1 FOR ADC GMP MANUFACTURE
Piramal has been manufacturing ADCs for over 10 years with an unparalleled track record for GMP manufacture.

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Facilities

  • Three clinical and Commercial scale ADC GMP manufacturing suites
  • MHRA authorisation (EU Licence) for manufacture of Medicinal Product and Investigative Medicinal Products (IMP)
  • Approved for commercial ADC supply by FDA and other worldwide authorities
  • Successfully audited by US FDA, MHRA, PMDA, ANVISA and Turkish Ministry of Health
  • Isolator technology
  • All suites offer chromatographic purification capabilities
  • Batch sizes up to 2.5kg input mAb
  • Up to 1000L reactive volume capability depending on complexity
  • Dedicated or single use produt-contact manufacturing components
  • Handling capability for derivatives or analogues of highly potent cytotoxic agents or natural and synthetic origin - auristatins, maytansanoids, duocarmycins, etc.
  • Containment to 10ng/m3 OEL

#1 For A Reason

  • Over 600 ADC batches manufactured
  • Over 300 GMP batches manufactured
  • Over 130 different ADCs from over 85 different antibodies
  • Over 40 different toxin/toxin-linker system
  • Over 25 different ADCs manufactured to GMP
  • Over 100 commercial GMP batches manufactured

Supply Chain Management

  • 100% successful shipments to Europe, US and Japan
  • Well-established relationship with World Courier and Pharmafreight
  • Temperature logging on all shipments
  • Typically 2-3 days shipment time
  • Shipping on small insulated boxes, cryocontainers and drums

Other Offerings

Proof-of-Concept Preclinical Development Studies

Conjugation Process Development and Scale Up

Pre-clinical and Toxicology ADC Manufacture

ADC Clinical and Commercial Manufacturing

ADC Fill/Finish

Analytical Method Development Services

Bulk Drug Substance and Finished Product Release Testing

In vivo an Imaging services

Piramal offers a fast-track early stage development service for your ADC programmes. Whether you are selecting your candidate mAb, linker or toxin, we have a programme that will meet your needs. Tailored to perfection.

Piramal offers ADC process development and scale-up through Tox manufacture and into GMP manufacture. Our highly experienced team has been working on ADCs for over 10 years, working on over 130 different ADC candidates and over 40 different toxin/toxin-linker systems.

We have been providing pharmaceutical intermediate and API process development services for nearly three decades from our network of R&D and manufacturing facilities across the globe.

World-leading multi-product facility for clinical and commercial manufacturing of antibody drug conjugates (ADCs). Process development. characterisation, optimisation and scale-up expertise supporting successful GMP manufacturing.

Piramal offers aseptic filling of ADC drug product through our FDA-approved state-of-the-art manufacturing facility in Lexington, KY. Our facility is centred around mobile isolator technology, providing an ISO 5 environment during processing, as well as product containment for potent and cytotoxic products.

Piramal's highly experienced Analytical Development team covers a wide range of analytical methods from small molecule analysis through to cell killing assays and ELISA development. All your analytical development and testing requirements on a single site.

We have been providing pharmaceutical intermediate and API process development services for nearly three decades from our network of R&D and manufacturing facilities across the globe.

We have been providing pharmaceutical intermediate and API process development services for nearly three decades from our network of R&D and manufacturing facilities across the globe.

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