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In the pharmaceutical industry, it is well known that: The drug product picks the package. Not all package systems are compatible with a particular drug product.
Figure: HSP of the lyophilized BSA powder determined by HSPIP software
For biologic drug products especially, selecting the right package system is essential; the wrong selection can result in deleterious interactions, e.g.:
Typically, selection is made empirically. At 2018 PepTalk, West’s Dr. Liang Fang, Principal Scientist, Scientific Insights Laboratory, spoke on a new approach to aid selection, in a poster titled Protein Adsorption Explained by Hansen Solubility Parameters. This approach is theoretical – it employs Hansen solubility parameters to understand the interaction of protein molecules with surfaces, and how that interaction is influenced by intermolecular forces. It represents a high-throughput method that can screen-out package system components that are likely to have an unwanted interaction with drug product, and enables focus of always-limited experimental resources on components that are likely not to have an unwanted interaction. This approach does not eliminate the need for experimental evaluation of a package system; rather it makes it more efficient.
West is committed to safe, efficient delivery of drug products to patients – developing new methods to select the right package system is a key element of this commitment. For more on West products and services, contact a Technical Customer Support (TCS) representative or visit the Knowledge Center.
For the second consecutive year since its inception, a total of 91 West employees rose to the challenge and participated in the actimonda Business Run on May 15 in Aachen, Germany.
<span style="color: #000000;">In a recent Flash Report, Rx-360.org offered a summary of the proposed USP Chapter 1083 – Good Distribution Practices – Supply Chain Integrity. In its report, Rx-360 noted that “globalization of all aspects of the pharmaceutical business has driven the need to address the threats of counterfeit or adulterated medication, devices and components, for which there have been several high-profile examples over the last few years.”</span>
One of the most important aspects for choosing container closure system for parenteral drug products is to ensure an ideal fit between all components to maintain product sterility.
At West, we often get asked “What extractable compounds are present in your products?”, “What are the current requirements for Extractable and Leachable testing?” and “How do I make sense of all of this data and get the regulatory authorities what they want?”
Recently, West Interns from the Exton headquarters volunteered at the Thorncroft Equestrian Center in Malvern, Pennsylvania. Established in 1969, Thorncroft is a Therapeutic Equestrian Center that provides horseback riding to children and adults with mental, emotional and physical disabilities, with the mission to develop the physical and emotional well-being of all people, regardless of their individual challenges. As volunteers, the interns participated in various maintenance activities around the farm to help preserve and support the valuable experience that Thorncroft continually provides to our community.
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