Contract manufacturing news in brief

Adventrx Pharmaceuticals has recently enlisted the help of contract manufacturing organisation (CMO) Pharmatek Laboratories to make the capsules of its experimental HIV drug for planned clinical trials. The Phase I-II study of ANX-201 (Thiovir) is due to begin in the third quarter of this year, pending US Food and Drug Administration (FDA) clearance of the investigational new drug application (IND) that the company will submit in the second quarter. ANX-201 is a member of a new class of reverse transcriptase inhibitor (RTI) designed for oral delivery as a component of AZT-based antiretroviral therapy. It is a pyrophosphate analog which delivers both thiophosphonoformate (TPFA) and phosphonoformate (PFA, foscarnet). According to Adventrix, the HIV resistance profile of ANX-201 and foscarnet is unique among RTIs due to the distinct mechanism of action of this novel drug class. Meanwhile, biopharmaceutical CMO Diosynth Biotechnology has signed an agreement with Talecris Biotherapeutics for process development and production of clinical trial material for a unique form of recombinant plasminogen. Recombinant plasminogen is an intermediate material used in the manufacture of recombinant Plasmin, a second-generation therapy Talecris is developing as an ophthalmic and thrombolytic treatment. Commenting on the decision to use Diosynth, Steve Petteway, senior vice president of R&D at Talecris said: "They have a strong track record in process development and production of both clinical and commercial products. Additionally, they have accomplished this across a range of molecule classes that goes beyond a typical CMO offering."​ Terms of the deal were not disclosed. In other news, Chinese contract manufacturer WuXi PharmaTech has announced that it has now installed a Berger supercritical fluid chromatography (SFC) MultiGram-III preparative system - making it the first company in China to do so. SFC is a relatively recent chromatographic technique offering superior speed and efficiency for chiral separation and compound purification, said WuXi PharmaTech. Preparative SFC uses carbon dioxide as mobile phase instead of organic solvents in high-performance liquid chromatography (HPLC), making it a green technology for rapid access to enantiomers in the pharmaceutical industry. The firm said this latest addition will play an important role in the research and separation of chiral drugs and intermediates and expands its chiral separation capability from multi-grams to multi-kilograms. "It also greatly expands the capability of our kilogram-scale laboratories, enhancing analytical efficiency,"​ said the company.