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China has now stepped into its “golden age” of biopharma; this year regulators approved the country’s first biosimilar product, HLX01. Developed by Shanghai Henlius Biotech, it will be used primarily for treatment of non-Hodgkin’s lymphoma. Biologics are sensitive large molecules, so selecting the appropriate packaging and delivery system is critical. To this end, West Pharmaceutical Services, Inc. (“West”) recently held China BioPharma Summit for Injectable Drug Packaging and Delivery Systems in Suzhou. Over 200 persons attended.
A broad range of topics were discussed by speakers from West, Daikyo Seiko, Ltd., China National Pharmaceutical Packaging Association (CNPPA), Shanghai Food and Drug Packaging Materials Control Center, Shanghai Henlius Biotech, Wuxi Biologics, and GBI. Highlights included:
West is committed to staying abreast of world-wide drug product developments and supporting customers in getting the right packaging and delivery systems for their products. For more on West, contact an Account Manager or Technical Customer Support (TCS) representative.
<p style="margin: 0in 0in 10pt;">The new regulation “Bundling Review and Approval of Packaging and Excipients with Drug Products” announced by the China Federal Drug Administration (CFDA) on August 10, 2016, has generated both interest and concern. While the CFDA has published several related guidelines in an effort to address questions, many still persist. </p>
Effective change control systems are important for pharmaceutical packaging materials – especially those in direct contact with drugs. This topic has high visibility in the China pharmaceutical packaging industry as a new change control strategy for pharmaceutical packaging materials is coming.
At West, one of our core values is passion for customers. Their success is ultimately our success. Understanding our customers’ unique challenges and focus areas, ultimately helps us to better provide solutions for their needs. Recently, the West China Commercial Team visited one of our major local customers, Wuxi Biologics, and hosted its first large-scale on-site customer event, “Innovation Day.” As one of our major local customers, Wuxi Biologics is a leading company in China’s prosperous biopharmaceutical industry. The event drew over 140 participants and expanded our strategic collaboration, which will help us further support Wuxi Biologics with their specific drug development needs.
<br />In 2016, the China Federal Drug Administration (CFDA) made two announcements regarding packaging of parenteral drug products. Per these announcements, stability studies of packaging materials should refer to protection, compatibility, safety and functionality properties.
Extractables and leachables (E&L) pose a potential risk to patient safety. Both pharmaceutical companies and regulatory agencies have rising concerns regarding E&L, which has led the <em>Center for Drug Evaluation</em> under the China Federal Drug Administration (CFDA) to release a new standard for public comment (December 30, 2016): <em>Technical Guideline for Compatibility Study of Chemicals and Elastomer Closures.</em> The compatibility study discussed therein focused on E&L.
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