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.

Piramal can support of the analytical development, validation and quality control release testing needed to get your ADC to clinic or market. Method development and testing to fully characterize your ADC in all key quality attributes including: Identity, Strength, Potency, Purity, Safety and Quality.

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Analytical Development and Validation

  • Highly experience team with varied skill set
  • World-Class expertise in Cell Based Assay development and validation
  • Extensive industry experience
  • Method development for HPLC (HIC, SEC, PLRP), icIEF, CE-SDS, SDS-PAGE, ELISA, Cell Based Assays, Cleaning methods
  • Qualification/Validation or Transfer of Methods
  • Commercialisation activities support

Drug Substance & drug product Release and Stability Testing

  • State-of-the-art onsite quality control laboratory
  • Over 10 years’ experience of routine testing of ADCs, including cell based assays and ELISA
  • Toxicology, Bulk Drug Substance and Finished Drug Product release testing
  • Full testing to ICH guidelines
  • Over 80 stability trials conducted for clinical and commercial ADC GMP batches

Cell Based Assay Experienced

  • World leader in development and validation of Cell Killing Assays (CKAs)
  • Tailored development programs utilising Design of Experiments approaches
  • Experience in Technical Transfer/Optimisation of client methods
  • Multiple CKAs developed and validated to meet client and regulatory requirements
  • Expert knowledge of validation to regulatory standards, <1032>, <1034> and PhEur 5.3

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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