Drug Substance Manufacturing
Our dedicated team of scientists leverage our global resources to support a range of ADC activities for wild-type stochastic and site-specific conjugation technologies, as well as our next-generation AJICAP site-selective technology.
Our advanced, single site facility provides the capacity and quality systems need for safe, effective, and efficient ADC bioconjugation from early discovery stages to GMP manufacture for clinical and commercial applications.
Our cutting-edge manufacturing and leading conjugation technologies allow us to optimize cost and shorten timelines to market.
We support a broad range of stochastic and site-specific product needs.
- Protein Conjugates:
- Antibody Drug Conjugates (ADCs)
- Protein Drug-Conjugates
- Antibody-Protein Conjugates
- Protein (re)folding
AJICAP® is innovative direct chemical site-selective conjugation method for intact native antibodies, offering significant advantages for next generation ADCs.
With AJICAP, site specific ADCs are generated from native antibodies, saving months of time in early development, providing time savings in early development.
- Wide Antibody Compatibility
- Direct modification of native antibody
- Antibody modifications well-tolerated but not required
- Wide Drug-Linker Compatibility
- Hydrophobic payloads
- Thiol and azide conjugations
- Therapeutic Window Enhancement
- Improvements in PK and efficacy
- Site specific, controlled DAR 2
- Straightforward Manufacture
- High productivity
- Short conjugation reaction times
- Ease to manufacture
- AJICAP® technology screening
Development Aligned with Manufacturing
We provide reliable, robust, tailored, and cost-effective development and cGMP manufacturing services to efficiently take your ADC from clinical development to commercialization.
- Small scale conjugation screening
- Customizable ADC sample prep
- Material generation for pre-clinical studies
- Analytical development and technology transfer
- Conjugation process development (mg to g scale)
- Conjugation process optimization & UF/DF development
- GLP tox batch
- GMP drug substance manufacturing
- Reactor sizes: 10 -100 L (single use systems)
- Single use TFF unit with membrane capacity up to 2 m2
- Single use chromatography system