Related Offerings
ADC Clinical/Commercial Manufacturing
We are a world-leading multi-product facility for clinical and commercial manufacturing of antibody-drug conjugates (ADCs) and other bioconjugates. Besides, we have a robust process development, characterization, optimization, and scale-up expertise supporting successful GMP manufacturing.
#1 FOR ADC GMP MANUFACTURE
Piramal has been manufacturing ADCs for over 15 years.
Facilities
- Three clinical and commercial-scale GMP manufacturing suites
- Successfully audited by US FDA, MHRA, PMDA, ANVISA, and Turkish Ministry of Health
- All suites can support chromatographic purification capabilities
- Batch sizes up to ca. 3kg input mAb
- Up to 1000L reactive volume capability depending on the complexity
- Dedicated or single-use product-contact manufacturing components
- Handling capability for derivatives or analogs of highly potent cytotoxic agents or natural and synthetic origin: auristatin, maytansanoids, duocarmycins, and others
- Containment to 10ng/m3 OEL
#1 For A Reason
- Over 900 ADC batches manufactured
- Over 500 GMP batches manufactured
- Over 190 different conjugates from 120 antibodies
- Over 60 different toxin/toxin-linker system
- Over 35 different ADCs manufactured to GMP
- Over 200 commercial batches manufactured