Our authors from today's excerpt Robert Large, Senior Process Development Engineer, Grifols, Inc., Jared Ragone, New Product Development Engineer, Charter Medical, Ltd., Joe Petrosky VP of Global Sales and Marketing,Charter Medical, Ltd., Dominic Clarke, PhD, Product Manager, Cryogenic Storage and Cellular Therapy, Charter Medical, Ltd. In November 2009, Talecris Biotherapeutics announced an ambitious US$269 million expansion of its Clayton, NC, manufacturing facility. The company was subsequently purchased by Grifols, Inc. in 2011. Constructing a new facility with a state-of-the-art manufacturing process intended to generate clinical products involves top-notch project management, exceptional fortitude, and numerous supply chain decisions. Suppliers are often relied on to provide standard product support. When used effectively, they can be an invaluable resource beyond basic services. Additional support may include engineering expertise, custom device development, and even regulatory insight.
Forming strategic partnerships with the right suppliers is important to preventing critical-path project delays. When a biopharmaceutical company builds a new manufacturing facility and implements a novel process design, not all suppliers are willing or able to provide the necessary product support in the time required. As a leading provider of plasma-derived therapeutic components, Grifols relies on quality partnerships to achieve its complex production goals. Below is a case study of the key partnership between Grifols and single-use systems (SUS) supplier Charter Medical, Ltd. (CML), of Winston-Salem, NC. The output of this alliance was development and implementation of a crucial SUS processing component in time to keep the new facility's opening on schedule.
Headquartered in Barcelona, Spain, Grifols is a multinational healthcare company. This principal producer of blood-plasma–based products also supplies devices, instruments, and reagents for clinical testing laboratories. The company is a major world supplier of intravenous immunoglobulin (IVIG), albumin, blood factor VIII, and other plasma-derived products. The global bioscience division of Grifols is committed to hemotherapy and producing life-saving protein therapies, with a standing mission to improve the health and well-being of patients around the world. These hemotherapeutic products are derived from human plasma, the liquid portion of human blood that contains essential proteins for treating rare, chronic, and life-threatening conditions (immune deficiencies, bleeding and blood-clotting disorders, alpha-1 antitrypsin deficiency, and so on) (1).
Grifols built a leading-edge plasma fractionation manufacturing facility in Clayton, NC, where the company is implementing and upgrading the proprietary centrifugation process it uses to obtain the plasma fractions. During installation qualification (IQ), Grifols encountered an issue with an SUS component necessary for the processing and storage of the precipitated fractions. Process development engineers reached out to CML for assistance.
CML has an ISO 13485 certified manufacturing facility located in Winston-Salem, NC. The company's vital fluid business serves bioprocessing and medical device customers. It designs and supplies both standard and custom SUS for processing cell-based and biologic fluids in biotech and clinical applications.
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