Services

ADC Conjugation Process Development

During ADC conjugation, the drug or payload is connected to the antibody via a linker with specified drug-antibody-ratio (DAR). The objective of process development is to design process routine, optimize conjugation reaction process parameters, and purify target products by reducing product related impurities (aggregates, fragment) and process-related impurities (residual free drug, residual solvent).

• Conjugation process development

• Small-scale conjugated sample preparation

• Technology transfer & process scale-up

• Tox DS manufacture

Early Phase Conjugation Development

Key Features of Our Conjugation Process Development Platform

Dedicated Lab: We have a dedicated lab equipped with negative pressure isolator and cabinet to support ADC development and to protect operators.
Experienced: - Successfully delivered lysine, cysteine, and enzyme-mediated conjugation processes.
- Conducts one-factor-at-a-time (OFAT) and DOE studies based on deep understanding of reaction chemistry to design optimized processes.
Fast: - Milligram to gram-scale ADC samples delivered within 3 weeks of receiving key starting materials.
- GLP ADC samples provided with established IND process within 8 months from the mAb DNA sequence.