OUR CAPABILITIES SPAN THE GLOBE AND
ENCOMPASS ALL ASPECTS OF ADC PRODUCTION
The PROVEO™ alliance provides our clients an efficiency generated by our fully-integrated and qualified project and supply chain management. We supply a global reach, and decades of ADC experience to create a fully realized and configurable ADC solution.
Copenhagen, Denmark, Bothell, WA, Berkeley, CA, U.S.A:
- EMA and FDA approved for commercial production.
- Upstream and downstream development capabilities.
- Multiple mammalian cell culture lines from 100L to 3000L.
- Experts in microbial and perfusion technology, with 2x1500L microbial line.
- First in market Bioreactor 6Pack™ facility — 6x2000L single-use cell culture line.
- New 2x500L facility available in 2017.
- Analytical and DS/DP formulation development, including bioassays.
- Development and GMP Manufacture of cytotoxic payloads (PBD, Auristatins, etc.) from grams to kgs scale.
- Technical transfer of different conjugation technologies for GMP bio-conjugations process manufacturing, from grams to kgs scale.
- Purification of ADC substances (UF/DF/Chromatography).
- From Tox batch to commercial manufacturing.
- Analytical methods development and validation for free payloads and bio-conjugated material.
- ADC small- scale filling line with lyophilisation and vial washing for high potent drugs Q4/2017.
- ADC large-scale filling line with lyophilisation and vial washing for high potent drugs Q4/2018.
- Experts in formulation development and filling of clinical material.
- Large quality control unit with full method portfolio for characterization of biotech products vaccines and small molecules.
- Physico-chemical, microbiological, biochemical, immunological, virological testing, animal testing.
- Cold storage areas between -80 to 2-8°C also for commercial production.