Our full service offering for bioconjugate manufacture provides you with a tailored approach from drug intermediate manufacturing through drug substance manufacturing, all under one quality system supported by global regulatory services. We currently produce the majority of commercialized ADCs at our site in Visp, Switzerland, supplying more than 60 countries globally including Japan.
Our capabilities and services for Drug Substance Bioconjugate Manufacturing include:
- cGMP facilities with safety procedures in place to handle cytotoxic compounds with OEL down to 1 ng/m3
- Small scale conjugation facility: 50 –1,000 g scale
- Large scale conjugation facility: 0.5 –5.0 kg scale
- Qualified stainless steel and single-use equipment
- Aseptic biopharmaceutical manufacturing environment
Our scientists and engineers bring years of development experience across a broad spectrum of both platform and novel conjugation technologies. Our services are geared to enable the commercialization of your drug candidate and we have a successful track record of process design and execution of validation/conformance batches to support PAI, launch, and commercial manufacturing requirements.