Contract manufacturing news in brief
new contract manufacturing deals this week.
Adventrix Pharmaceuticals has enlisted Hyaluron Contract Manufacturing to preclinical- and-clinical supplies of its biologic cancer and infectious diseases treatment, ANX-514 (docetaxel emulsion). The compound is being groomed as a "follow-on" or "biosimilar" competitor for the branded chemotherapy drug Taxotere (docetaxel), which is approved to treat breast, non-small cell lung, prostate, gastric and head- and-neck cancers. Adventrix said ANX-514 is a novel nano-emulsion formulation of docetaxel, as it is formulated without polysorbate 80 or other detergents, with the intention of reducing the severity and/or incidence of hypersensitivity reactions. It is designed to eliminate the need for multi-day immunosuppressant premedication, said the firm, something that is normally recommended for docetaxel therapy to reduce the incidence and severity of allergic reactions. Evan Levine, CEO of Adventrix said ANX-514 is currently undergoing preclinical pharmacokinetic testing and the company hopes to initiate a "marketing-enabling" clinical trial later this year. Hyaluron Contract Manufacturing is a leader in aseptic contract manufacturing of filled liquid parenterals and medical devices. Meanwhile, MultiCell Technologies has inked a long-term agreement with Lundbeck Pharmaceuticals Italy for the supply of one of the active components of its Phase IIb drug for the treatment of chronic fatigue in patients with multiple sclerosis (MS), MCT-125. Over 75 per cent of the world's two million MS sufferers reportedly experience chronic fatigue and 50-60 per cent of these cite it as the worst symptom of their disease. Lundbeck is a US Food and Drug Administration (FDA)-inspected manufacturer of proprietary active pharmaceutical ingredients (APIs) and intermediates and provides contract manufacturing services to many large pharmaceutical firms. Commenting on the new relationship, Dr Stephen Chang, president and CEO of MultiCell Technologies said: "This contract is enabling, and helps us advance MCT-125 toward commencement of our planned Phase IIb human clinical trials." Meanwhile, ProBioGen will now develop a biopharmaceutical cell line for the high-level production of one of the lead candidates in Affitech's oncology therapeutic antibody pipeline. Dr Martin Welschof, CEO of Affitech said: "While several of our in-house discovered human antibodies are in various stages of preclinical development, in order to meet the demands of our ambitious development program for oncology antibody therapeutics, we have chosen a partner who offers us a high degree of flexibility and a compatible service-based development model." Under the terms of the agreement, ProBioGen will apply its cell-generation process for biopharmaceutical cell lines, relying on the unique vectors and its pre-optimised CHO starter cell, said the firm. This will be combined with an automated cloning process to identify and develop a high producer line, which should be particularly suitable for a fed-batch development process. Financial details of the agreement have not been disclosed. In other related news, Laureate Pharma has now opened its new pilot biopharmaceutical manufacturing plant in Princeton, New Jersey, US. From the new facility, the contract manufacturer will develop, produce and purify early-phase preclinical proteins. The firm said the plant is now available for early engineering runs and manufacturing of product for uses such as formulation and toxicological testing. The pilot plant is designed for process development, production and purification of early-phase preclinical proteins. The facility also features two separate production suites and two expanded purification suites to support preclinical production of recombinant proteins from mammalian-cell culture, said the firm. In addition, the suites are designed to reflect the company's existing production facility, including both stainless-steel, stirred-tank bioreactors and disposable, single-use bioreactors, and featuring the same process chromatography and filtration technologies. "The equipment in our pilot plant facility is designed to facilitate a direct, seamless scale-up from development to cGMP production for our clients' projects," said Robert Broeze, Laureate's president and CEO. "With the new pilot plant in operation, we can accelerate our manufacturing of pre clinical material and save several months worth of critical product development time."
