The Axis-D pen from Haselmeier GmbH is to be used by Merck Serono, a division of Merck KGaA, Germany. Haselmeier designs and manufactures pen and auto-injection systems designed to allow self injection by patients of a ready-to-use biopharmaceutical solution.
Combination products and copackaged medical products are evolving. Growth in drug self-administration is being fueled by changing patient populations, efforts by managed-care providers to control healthcare costs, and a focus on safety and compliance. According to Code of Federal Regulations Title 21, a combination product comprises any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.
Vetter, a provider of aseptic prefilled drug delivery systems, announces that its Chicago facility is ready to accept client projects. Located at the Illinois Science + Technology Park in Skokie, IL, the facility provides cGMP filling for vials, syringes, and cartridges, supporting preclinical through phase II products.
Gerresheimer AG has commenced the commercial production of ClikSTAR insulin pens for sanofi-aventis. Medical plastic systems, such as insulin pens, will be increasingly important in the Gerresheimer product portfolio in the future because they incorporate a dosage and application function in addition to being a pure medication packaging. The re-usable ClikSTAR insulin pen has received the Good Design Award.
Demand for prefilled syringes continues to grow, reports Yves Buelens, general manager of Catalent Pharma Solutions’ (www.catalent.com) Sterile Technologies facility in Brussels, Belgium. Catalent offers a wide range of services to the pharmaceutical industry from drug development through clinical and commercial manufacturing and packaging services. Catalent processed a large number of prefilled syringes in 2009 on its three filling lines in Brussels, and the firm is poised to add a fourth line.
Catalent Pharma Solutions (www.catalent.com) announced that it has entered into an agreement with Nuron Biotech for the formulation and supply of NU100 (interferon beta-1b), a proprietary recombinant human interferon beta compound being developed for the treatment of multiple sclerosis (MS).
Manufacturer-prepared, premixed ready-to-use products represent a preferred approach to advance initiatives and professional standards for improving intravenous drug safety. Organizations that promote, support, and monitor implementation of practices intended to assure quality services in the hospital environment include the Joint Commission, the United States Pharmacopeia, and the American Society of Health System Pharmacists.
West (Lionville. PA) has introduced the Daikyo Crystal Zenith 1mL long insert needle syringe system. The system was introduced to the market at the Parenteral Drug Association’s Universe of Pre-filled Syringes and Injection Devices Conference in Las Vegas, October 18-19.