ATMI LifeSciences takes joint-venture route into Asia-Pacific

By Peter Mansell

- Last updated on GMT

Related tags: Asia-pacific, Atmi

ATMI LifeSciences, a Belgian company that manufactures and supplies
film-based single-use packaging products for the biopharmaceutical
industry, has set up a joint venture, ATMI Austar LifeSciences,
Ltd, in the Shanghai area of China.

The joint venture with Hong Kong-based Austar will manufacture and market high-end, ultra-clean sterile materials packaging for the pharmaceutical industry in the Asia-Pacific region. ATMI LifeSciences has invested "about a million dollars"​ in the tie-up, said Dean Hamilton, director of investor relations and corporate communications for parent company ATMI, a global supplier of semiconductor materials for manufacturing of integrated circuits with headquarters in Danbury, US. Its first foray into the Asia-Pacific region will bring the lifesciences business "closer to a number of our key pharmaceutical customers"​, he added. As well as giving the ATMI LifeSciences access to the active pharmaceutical ingredient and biopharmaceutical markets in Asia, the joint venture adds manufacturing capacity to the core facilities in Hoegaarden, Belgium that manufacture the company's Newmix and Newform product lines, noted managing director Mario Philips. Austar, which provides engineering design, project management services and technical support services as well as Good Manufacturing Practices consultancy to the pharmaceutical industry in China, "offers broad expertise and an existing ISO Class V GMP-certified cleanroom-based infrastructure that we can begin to leverage immediately"​, Philips pointed out. Austar has branch offices and companies in Beijing, Shanghai, Shijiazhuang, Guangzhou and Chengdu. Under the joint-venture agreement, ATMI Austar LifeSciences will manufacture ATMI LifeSciences products, including the CleanSteam line, with local blow-film extrusion and packaging converting lines using a copy-exact strategy. "Together, under the ATMI Austar LifeSciences banner, we are working to create a new standard for advanced materials packaging for pharmaceutical manufacturing throughout the region,"​ Philips commented. The expansion into the Asia-Pacific region reflects both the wider trend towards siting manufacturing facilities in lower-cost markets and the more specific cost and cleanliness advantages of "getting away from big stainless steel vats",​ as Hamilton put it. "More flexibility at lower cost means the pharmaceutical manufacturers are converting to the film-based, single-use packaging products that ATMI Austar LifeSciences will be able to provide locally,"​ said Mars Ho, chief executive officer of Austar. "The pharmaceutical market in Asia is expanding rapidly as more multinational firms look to extend their manufacturing capabilities into this vital region. Local supply and support is an important competitive differentiator."​ According to Hamilton, there are "probably half a dozen"​ companies already serving this marketplace in the Asia-Pacific territories. Nonetheless, "we think we've got technologies that go beyond what's out there now"​, he comments - specifically products that address manufacturing needs "better, faster, easier and less expensively".​ These products include CleanSteam bags, the initial focus for the joint venture and a well-recognised brand within the industry, Hamilton says. In the long term ATMI LifeSciences would like to be able to manufacture its whole product range locally, he adds. Part of the Newform range of ultraclean sterilisable packaging, CleanSteam bags can be used to package stoppers, vials, syringe components, medical devices or sterile containers. The line was developed by bonding uncoated Tyvek, an industry standard for sterile medical packaging manufactured by Dupont from very fine, high-density polyethylene fibres, with high-density polyethylene (HDPE). The result, ATMI LifeSciences says, is a low-linting, microbial barrier package that is virtually impervious to airborne particles. Among the product's other claimed benefits are a faster sterilisation cycling time due to the use of uncoated Tyvek, less ethylene oxide (EtO) absorption than ordinary paper packaging, and superior seal and burst strength. A more recent addition to the ATMI LifeSciences portfolio is the Newmix single-use system for mixing and storing pharmaceutical active ingredients in liquid or powder form. According to ATMI, Newmix is the only single-use system that can effectively mix powders when the powder content is more than 30% of the mixture. The Newmix vessels are manufactured with specially selected medical-grade film produced using ATMI's in-house extrusion process under a controlled environment. The closed-end, non-invasive design does not allow any contact between the mechanical impeller and the ingredients being mixed, nor is any expensive instrumentation required to control the mixing process, ATMI says. The Newmix system can blend high concentrations of powders and liquids at varied temperatures and volumes (from less than 1 to 200 litres) in a controlled environment. At the same time, ATMI notes, it eliminates the need to clean and sterilise between batches, cuts validation costs, lowers the risk of cross-contamination and protects the environment and operator from potentially toxic substances. The company offers two Newmix systems. X-Mix is for smaller volumes of up to 10 litres/kilogrammes. Homogeneity is achieved by rotating a single-use hourglass-shaped bag around the unit's centre point, resulting in optimum mixing of powder-to-powder, liquid-to-powder and liquid-to-liquid ingredients. The C-Mix system, designed for larger volumes of up to 200 litres, employs a single-use, drum-shaped bag that incorporates an enclosed and isolated stir-rod/impeller, with the ability to mix high proportions of powder into liquid.

Related topics: Drug Delivery, Processing equipment

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