AG011, which is also being assessed in Crohn's disease (CD), is a preparation of the food bacterium Lactococcus lactis that has been modified using ActoGenIX' TopAct technology to deliver the anti-inflammatory cytokine interleukin 10 (IL-10) to the gastrointestinal (GI) tract. While IL-10's potential role in the treatment of inflammatory bowel disorders was identified a decade ago, the compound's limited bioavailability in GI tissues and capacity to induce significant side effects at high doses has limited its use in such indications. ActoGenIX hopes that because AG011 can be delivered orally and is designed to mediate its effects in the GI tract directly it will be able to sidestep these problems. Phase II trials are expected to start later this year. Scalable production method To fulfil the AG011 contract, SynCo developed a scalable production method involving the cultivation, purification and lysophilisation of AG011 at its facility in Amsterdam. Further details of the manufacturing processes used, or the quantity of product released were not provided. Dr Joanne McCudden, SynCo's Director of Sales and Marketing told in-PharmaTechnologist.com that the firm had begun working with ActoGeniX in early 2007, and has developed a close collaborative relationship. She said: "working with a Belgian company was an advantage to SynCo due to its close proximity to the Netherlands," explaining that "we could just drive down the road to visit each other if discussions were complex' said Marcel Thalen, scientific officer at SynCo." McCudden also said that, while no new manufacturing jobs had been created as a result of the AG011 project, "SynCo is sustainably expanding its process development capabilities as it works with a greater number of clients each year. Our process development team has doubled in size in the last 2-3 years." McCudden went on to say that "SynCo is a pure play CMO and does not withhold rights to a manufacturing process from its clients. SynCo works with a number of companies across the globe in the development of processes for live-microbial-base products She added that the firm is focused on making sure that each process is scalable, robust and closed as is essential for products that cannot be sterilised. Previously, SynCo has produced active pharmaceutical ingredients for Novartis' meningitis C vaccine and monoclonal antibodies for Oncomed's stem cell-based cancer treatment. The Dutch firm has also developed production processes for range of companies including Cleveland BioLabs and ACE Biosciences. McCudden added that: "in terms of whether ActogeniX and SynCo will work together in the future: SynCo does produce products for clinical and commercial supply and is therefore able to support ActogeniX all the way to licensure if required."