Agreement combines development, manufacturing and formulation of ADCs20 September 2012
BUBENDORF, Switzerland (September 20, 2012) — Switzerland-based CARBOGEN AMCIS, a pharmaceutical process development and active pharmaceutical ingredient (API) manufacturing company, has announced a formal collaboration with UK-based ADC Biotechnology (ADC Bio) to provide customers with seamless development and manufacturing services for antibody drug conjugates (ADCs) – a key anti-cancer treatment platform. ADC Bio is developing a “lock and release” solid phase immobilisation technology for efficient production of ADCs.
The alliance will offer a complete range of services to customers for the development, scale-up, manufacturing and formulation of protein-based drug conjugates. ADC Bio will provide access to proprietary solid phase immobilization technologies for conjugation and long-term storage of ADCs whilst CARBOGEN AMCIS will focus on small to large scale GMP supply and on the formulation of ADCs. The market for ADCs is growing rapidly, with therapeutic proof of concept established through the recent approval of ADCETRIS. The commercial value of the ADC drug market is projected to reach $5 billion by 2015. Several ADCs are in late-phase trials, with over 60 in pre-clinical testing.
"CARBOGEN AMCIS’ goal is to help clients to advance drug candidates through the development pipeline with greater speed by delivering innovative chemistry solutions,” said Mark Griffiths, CEO of CARBOGEN AMCIS. He continued, “Through this alliance, we provide our customers access to ADC Bio’s particular expertise in the conjugation of proteins and antibodies to toxins by “lock and release” technology. The partnership will enable us to provide robust and efficient processes under GMP at multiple scales, which presents a significant new service offering for ADC developers and producers.”
"By combining ADC Bio’s step-change technology in ADC immobilisation with CARBOGEN AMCIS' impressive track record in development and manufacturing services, the two companies together can offer seamless ADC services for both development programmes and manufacturing campaigns,” added ADC Bio’s CEO Charlie Johnson.
ADC Bio offering:
- ADCs for primary efficacy screening;
- ADCs based on multiple toxin-linker platforms;
- Development of novel toxin-linker combinations;
- Pre-clinical supply of ADCs;
- “Lock and release” solid phase immobilisation technology;
- Scale up and tech transfer.
CARBOGEN AMCIS offering:
- Supply of GMP and non-GMP material for toxicological studies and clinical trials;
- GMP lyophilisation services;
- Fill and finish capabilities;
- Large-scale, custom manufacturing services;
- Project management;
- Regulatory support.
CARBOGEN AMCIS (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is owned by Dishman Pharmaceuticals and Chemicals Ltd., Ahmedabad, India.
ADC Biotechnology (www.adcbio.com) is developing new technology to speed and simplify conjugation and purification processes for antibody drug conjugates. With ADCs binding to solid polymer beads, “lock and release” features fewer, faster steps than conventional processing. Benefits include higher yields, lower costs and reduced production and environmental footprints. In late 2011, after a successful proof-of-concept programme at Sheffield University, ADC Bio secured a £450,000 package of investment and grant funding, led by Finance Wales and Acceleris Ltd. The North Wales-based company was formed in September 2010.
Dishman Group (www.dishmangroup.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe, China and India.
Source: CARBOGEN AMCIS AG, Bubendorf, Switzerland