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Antibody Drug Conjugation

Antibody Drug Conjugation

We are the pioneers in the field of GMP Manufacturing of Antibody Drug Conjugate products with a wealth of experience in Proof of Concept studies to Scale Up and Commercial Supplies. Our facility in Scotland is dedicated to process development, scale up and manufacturing of Bioconjugates with primary focus on ADCs. For over a decade, we have partnered with leading ADC technology companies and their licensees to develop robust processes used in pre-clinical, clinical and commercial supplies. We have made over 460 batches (>240 GMP batches) of ADCs spanning more than 60 distinct ADC candidates.

Services Offered

  • Process development, optimization and characterization
  • Pre-clinical and toxicology batch preparations
  • GMP manufacture of clinical and commercial supplies
  • Analytical and bio-analytical method development, technology transfer & validation
  • Stand alone Analytical Services,
    • Release testing of drug substance and drug product
    • Cell based assays
    • Stability study design and execution to ICH Q1
    • Performed over 70 stability studies
  • QP release of formulated bulk drug product
  • Proof of Concept studies
  • Rapid small scale conjugations (10mg – 5g) to screen a large number of conjugates with varying mAb/drug-linker combinations
  • ADC commercialisation services

  • Download our e-brochure here
  • To download pdf click here
  • Contact Us:
    Amar Karandikar
    Head Business Development, Formulations (North America)
    Landline: +1 732-686-5319
    Email: amar.karandikar@piramal.com