Antibody Drug Conjugation

Antibody-drug conjugates (ADCs) are antibodies armed with highly potent cell killing drugs used to target diseased tissues while leaving healthy tissue untouched. For nearly a decade, we have partnered with leading ADC technology companies and their licensees to develop robust processes used in preclinical, clinical and commercial supplies.

Pharma Solution has made over 300 batches of ADCs spanning over more than 30 different NCEs. We leverage this unparalleled experience to shorten development timelines whilst delivering robust processes for ADCs. As the market for ADC products expands rapidly, Pharma Solutions continues to evolve its services and capabilities in providing leading development and manufacturing experience and expertise.

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Value offering:

• Distinct business unit, dedicated to ADC programs.
• Dynamic R&D team with both biologic and chemistry skill sets.
• Flexible manufacturing regime in FDA inspected facilities.
• Full quality control of analytical & bioanalytical methodologies.
• High safety & containment standards.

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Key services & capabilities:

• Process development, optimisation and characterisation.
• Preclinical and toxicology batch preparations.
• GMP manufacture of clinical and commercial supplies.
• Analytical and bioanalytical method technology transfer, development and validation.
• Stability study design and execution (bulk drug substance & finished drug product).
• Full QA and regulatory support.

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Technological competencies:

• Experience with multiple ADC platforms including Auristatins, Maytansines, Duocarmycinsand various linker technologies.
• Experience with all major conjugation chemistries including lysine and cysteinemethods of conjugation.
• Protein, Peptide & oligosaccharide conjugation.

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Process development approach:

• Expertise in optimising drug load, reducing aggregate formation and improving overall yield by performing:
  • Filtration studies and technique development.
  • Solution characterizations.
  • Formulation evaluations.
  • Final product characterization and purity evaluations.
  • Process safety assessments.
  • Cell-based assay optimization.

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