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Considering the world of commercial transparent polymers, Daikyo Crystal Zenith® cyclic olefin polymer (COP) clearly stands out – having very good resistance to oxygen/water and compatibility with drug product (it comprises only carbon and hydrogen). Other transparent polymers may suffer limitations, in one or more ways. For example, poly(vinylidene chloride) has outstanding resistance to oxygen/water, but lacks compatibility; sterilization can result in release of HCl. For parenteral drug products, polymer-based containment/delivery systems have many advantages compared to glass.
The advantages include:
And because coefficients of thermal expansion match more closely between rubber/polymer than between rubber/glass, there is lower risk of loss of container closure integrity (CCI) at cryogenic temperatures. In view of the advantages of polymers, the obvious question concerns the best polymer. The requirements are:
These points were considered in detail in the presentation: "Challenges in Low-Temperature Storage of Cell Therapy Drug Products at PepTalk 2020." Considered also were the O2 and CO2 permeability rates of COP-based containment systems, from room temperature down to -80oC and -180oC. Rates were for the first time quantified; and they were demonstrated in fact to be low. Moreover, these systems demonstrated excellent CCI down to -180oC. These data indicate that COP-based systems should be suitable for a wide range of drug products stored at cryogenic temperatures. For more, contact an Account Manager or Technical Customer Service (TCS) representative.
Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd. Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
West strives to be the world leader in the integrated containment and delivery of injectable medicines. The achievement of this goal relies on many factors, including a heightened awareness of industry and regulatory trends. By being able to anticipate these trends, West is better able to support its customers with the knowledge and services needed to ensure that drug products reach market on schedule.
In 2012, the pharmaceutical industry will face many challenges, not the least of which will be the need to adjust research and development and business models to respond to the growing importance of specialty pharmaceuticals. Such products include sensitive biopharmaceuticals and the growth of biosimilars. Efficiency in manufacturing and the ability to meet critical compliance standards are a must to compete and meet today’s challenges.
<p><em>Teams Place 15 and 28 out of 120 Teams</em></p><p>The West DragonPhyre and DragonPhlame teams placed 15<sup>th</sup> and 28<sup>th</sup>, respectively, out of the 120 teams competing at the 11<sup>th</sup> Annual Philadelphia Dragonboat Festival on October 6, 2012.</p>
On November 14, World Diabetes Day will be observed around the globe. Diabetes is a growing issue, with more than 415 million adults living with the disease, a number that is expected to increase to 642 million – or 1 in 10 adults – by 2040.
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.
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