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At the recent CPhI China Conference, we introduced our Integrated Solutions Program to the Asia Pacific Market. The Program is designed to help reduce risk, mitigate regulatory complexity and Simplify the Journey™ from molecule to market for our pharmaceutical partners.
West's Integrated Solutions Program provides customers with a comprehensive approach to drug containment and delivery system development. Available in defined and customized packages, the new offering combines West's suite of drug packaging and delivery products with the company’s proven expert testing and support services to meet the unique needs of the drug product and its delivery system at any stage of development, across all injectable formats.
“In the evolving regulatory environment in China, our customers are facing challenges associated with bringing new drugs to market quickly while maintaining cost efficiencies,” said Catherine Lee, Managing Director of West China. “The Integrated Solutions Program combines West’s 95-year history of being by the side of its customers with global expertise in packaging and delivery, with regulatory support to help local customers with the right work, done the right way to ensure an efficient move to market.”
For more information on our Integrated Solutions program click here or contact a technical service representative.
Simplify the Journey™ is a trademark of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.
Administration of cell therapy drug products requires the delivery of cell suspensions without loss of function or viability. Cells must be transferred aseptically from their original container closure system to the administration system by infusion. However, the common transfer practice of using needles and syringes to pierce vial stoppers to retrieve contents poses a risk, namely needle-stick injury to clinicians.
A parenteral drug product contaminated by particles is a potential health threat. In the bloodstream, particles can cause serious issues, such as capillary occlusion and immunogenic responses. In most cases, the observation of particles in a drug product leads to a recall.
Innovation in manufacturing involves a spectrum of evolution improvements resulting in what West’s partner Daikyo Seiko, Ltd. considers "Absolute Quality." Recent continuous improvement efforts helped Daikyo achieve even higher levels in cleanliness of elastomer products.
While medications can provide life-saving solutions to patients, they can also result in harm to medical personnel who might suffer unintended exposure to potent drugs. The seemingly simple act of placing a syringe needle into a septum-sealed vial can result in inadvertent needle-sticks, with potential drug exposure. Additionally, the transfer of potent chemotherapeutic drugs can result in fugitive droplets or volatilization of the drugs and therefore personnel exposure.
Since the 2012 New England Compounding Center tragedy that linked a deadly fungal meningitis outbreak to a failure to use current good manufacturing practices (cGMP),<sup>1</sup> compounding pharmacies have faced increasing scrutiny and regulation by the U.S. Food and Drug Administration (FDA). While registering with the FDA is still voluntary, only compounding pharmacies that register, and pass inspection, will be granted “503B” status as compounding outsourcing facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act.<sup>2</sup>
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