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Research has been expanding understanding of biological systems at an exciting pace. In parallel, the biotechnology industry has been rapidly evolving as different biological entities (e.g., cellular and gene-based products) are increasingly harnessed as resources and therapeutics. To maximize the global utilization of biotechnology advances and drive further advancement of the industry, standards are needed.
The International Organization for Standardization (ISO) has convened a technical committee (TC 276) that will address this need by identifying and filling gaps in standardization for biotechnology applications. West has been invited to join TC 276 to contribute its expertise regarding packaging and delivery systems. TC 276 is organized into five working groups that are creating normative and informative standards in the following areas:
The initial standards developed will be broad and horizontal in nature, but will provide the basis for more specific, vertical standards that address the goal of world-wide consistency. One committee expert cleverly compares the suite of standards to a well-known fast food chain, in that both seek to ensure consistent quality independent of location. The first standards are expected to issue in 2018. Additional standards will issue continually as needs are identified and participation from concerned industry, governmental and academic parties increases.
West’s commitment to support ISO TC 276, as well as other industry groups (e.g., PQRI, PDA), is an example of its long-standing commitment to products that enable the safest delivery of drug products to patients.
More information about the international ISO TC 276 Committee can be found here.
The US Mirror Committee is administered by the National Institute of Standards and Technology (NIST), click here to learn how to get involved.
West is pleased to announce that we’ve recently expanded our Online Store offerings to include a 20mm NovaPure<sup>®</sup> Ready Pack™ lyophilization stopper, adaptiQ<sup>®</sup> vials from SCHOTT and Ready Pack™ Flip-Off<sup>®</sup> CCS (Clean, Certified, Sterilized) seals. West’s Online Store is a one-stop solution for access to small quantities of some of West’s highest quality products, in stock and available ready-to-use in convenient small packs. Depending on their product needs, shoppers can now purchase a complete vial containment system with the option of selecting either Daikyo Crystal Zenith<sup>®</sup> or adaptiQ glass vials.
<p>The World Health Organization (WHO) estimates that of the 35 million healthcare workers worldwide, at least 2 million people, suffer accidental needlestick injuries each year. More than 20 pathogens have been reportedly transmitted from needlesticks. The most serious transmissions include: Hepatitis B, Hepatitis C and HIV. Two of the most common causes of needlestick injuries are two-handed recapping and the unsafe collection and disposal of sharps. According to Occupational Safety and Health Administration (OSHA), nurses have the most frequent exposure, registering almost 50 percent of needlestick injuries. Hollow-bore needles are the main cause of injury in 68.5 percent of all cases. <sup>1</sup></p><p> </p>
Recently, the generics pharmaceutical industry in the United States has seen the average time to market decrease significantly as approvals have steadily increased thanks to the introduction of the Generic Drug User Fee Amendments (GDUFA) in October 2012. The reduction in time has led pharmaceutical companies to seek out high-quality elastomer products that provide the regulatory simplicity necessary to bring their products to market quickly, helping to increase a company’s competitiveness and their drug product’s overall sales. The AccelTRA™ elastomer program is built on these features: Quality, Speed, Simplicity.<br />
Diane Paskiet will speak at the U.S. Pharmcopeial Convention’s “Suitability and Compatibility for Packaging and Delivery Systems: Extractables and Leachables” Conference, which will be held at USP Headquarters in Rockville, Maryland, on December 9-10, 2013.
After welcoming new Taiwan colleagues from Exosite to West three months ago, we are excited to announce the grand opening of our Taipei office, which marks another Digital Technology Center (DTC) in the Asia Pacific region.
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