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At West, our focus is on supporting the biopharmaceutical industry in qualification and commercialization of containment and delivery systems for injectable medicines. Selecting high-quality drug packaging that meets regulatory standards is essential to a drug manufacturer’s success. West’s top priority is delivering high-quality packaging products that meet the exacting quality standards and product specifications customers require.
West’s Global Technical Customer Support (TCS) Team is key to this effort – focusing on biopharmaceutical industry needs and partnering with customers throughout the process of selecting and qualifying primary packaging solutions and drug delivery systems. This includes a sound understanding of both the packaging requirements defined by the drug product and the regulatory standards. TCS also provides technical information and scientific data on West and Daikyo products, and facilitates interaction with other West services, e.g. West Analytical Services, to reduce drug product time to market.
Additionally, TCS is active in the biopharmaceutical industry, e.g., participation in industry groups, attending conferences and exhibitions, and delivering technical reports and presentations. This enables TCS to be constantly aware of the latest trends.
Broad technical knowledge, understanding of industry needs, and service excellence ensure that West TCS remains the scientific destination for customers.
Contact a Technical Customer Support representative today to see how West can support you bringing safe, effective drug products to the market.
Commitment to the safest and most efficient delivery of drug products requires a detailed understanding of the constantly changing regulatory landscape. Recently West presented a webinar series discussing the current regulatory requirements for packaging/delivery components and systems, to support not only customers, but the industry as a whole. Each averaged more than 300 registrants – clearly showing the interest in these areas.
For injectable drug products, coring and fragmentation of elastomer stoppers is a critical concern. This is caused by tearing or shearing a fragment of the stopper in a vial during insertion of a needle or a spike. The cores/fragments that enter the drug product may lead to harmful patient outcomes. Testing of stoppers is a must for many pharmacopeias. Coring and fragmentation is complex and influenced by many factors, in particular the stopper and the needle.
Since the Technical Guideline on Compatibility Study of Chemicals and Elastomeric Closures was published by the National Medical Products Administration (NMPA, previously known as CFDA) in April 2018, it is essential for pharmaceutical companies to perform compatibility studies. However, for some domestic pharmaceutical companies that lack experience, it is unclear how to perform such a study. To address this, a series of trainings was planned by China National Pharmaceutical Packaging Association (CNPPA) – with the first held in December 2018. There were over 100 attendees from pharmaceutical companies, pharmaceutical packaging companies, NMPA-affiliated labs, and the third-party labs. The training received positive feedback from the participants.
<p><strong>Part I</strong></p><p><em>This is a first in a two part series dedicated to the origins and attributes of the Daikyo Crystal Zenith® Polymer </em></p><p>In the early 1990s, Masamichi Sudo, founder and past president of Daikyo Seiko, Ltd., first developed the Daikyo Crystal Zenith polymer. This custom formulated cyclic olefenic polymer, available today in the Daikyo Crystal Zenith (CZ) portfolio of products offered by West, represents his lifelong ambition to improve all aspects of parenteral packaging and commitment to delivering the most precise formulation to the marketplace.</p>
In recent years, an increasing variety of biologic drugs have been developed including vaccines, recombinant proteins, gene and cell therapies. In China, this increased demand will be reflected in a significant growth in the size of the bio-pharmaceutical industry. As a result, the Chinese government is increasing its investment.