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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. Our New Process Introduction team works closely with our team in development to ensure the final process being transferred into the GMP manufacturing suite is fit for purpose. Piramal boasts a 100% success rate for introducing new projects to GMP that have been developed through our Process Development group. This group continues to support the client's programme through clinical trials and into commercialisation.
Process Development Activities
Piramal's competencies in process development include:
- Preclinical proof of concept studies
- Formulation development studies
- Conjugation chemistry optimisation
- Development and optimisation of supporting purification techniques
- Robustness and process characterisation studies
- Conjugation chemistry experience with non-cleavable, cleavable and enzyme labile linkers
- Experience with all major drug platforms
- Other proprietary drugs such as non-cytotoxic small molecule payloads and chelating conjugates for Radio immunotherapy/Imaging
- Worked with over 50 different toxin/toxin linkers
- Traditional and site specific conjugation experience
- Experience in conjugation to IgG1, IgG2, IgG4, engineered antibodies and fragments
- Over 310 ADC development or Toxicology batches
- Capability to work from mg to hundred gram scales
Proof-of-Concept Preclinical Development Studies
Conjugation Process Development and Scale Up
Pre-clinical and Toxicology ADC Manufacture
ADC Clinical and Commercial Manufacturing
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.