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A team of three Cornell University Biomedical Engineering graduate students recently completed a collaborative project with West focused on the development of a proof-of-concept delivery system for a veterinary application.
From Left to Right: Jim Thompson (West); Gustavo Anaya, Diego Cordero, Geoff Rouin (Cornell); Dr. Alex Lyness (West)
The project is part of a long-term relationship that West has maintained with Meinig School of Biomedical Engineering at Cornell University since 2007.
The Cornell-West program provides a unique opportunity for a group of students to gain experience through the completion of a summer internship at West prior to their graduate program. During the summer of 2018, the students researched the current enabling technologies that can be utilized in the development of advanced drug delivery devices.
This year’s team of Gustavo Anaya, Diego Cordero and Geoff Rouin, then completed a 10-month design project as part of their graduate program at Cornell. They strategically utilized the laboratory capabilities at the Cornell University Department of Biomedical Engineering to determine feasibility of fabrication and testing of a novel delivery system. A prototype and proposed functionality of the device was presented to subject matter experts at West HQ in Exton at the end of the 2019 spring semester.
“The internship with West was a great opportunity to learn how emerging technologies can be integrated into more advanced drug delivery systems,” said team member Geoff Rouin, who has since taken on a role as an Associate Biomedical Engineer at West. “Completing the project at Cornell provided me with practical experience in the medical device design process while also continuing my learning through technical engineering and professional coursework. I look forward to stepping into my new role with the company.”
Dr. Alex Lyness, Manager, Academic & Technology Research, noted: “The collaboration between West and the Biomedical Engineering School at Cornell has been very successful over the past decade. Having students work on a real world-project through their studies is a great learning experience in both directions and has led to many being recruited to the company. We now welcome Geoff, as the newest recruit from the program, and look forward to what he delivers to West in his new role.”
The Cornell Graduate Internship is one of many strategic academic partnerships that West Innovation & Technology has established to explore areas of interest and develop innovative drug delivery solutions. For more information on innovation at West, visit our website or contact us.
The regulatory environment is moving to a more science-based approach to Container Closure Integrity (CCI). This is driven by the recent publication of United States Pharmacopeia Chapter <1207> Package Integrity Evaluation – Sterile Products. Recently, West gave a webinar (377 registrants) titled <a href="https://www.youtube.com/watch?v=5K8R1jumXyU&feature=youtu.be">Container Closure Integrity: Six Keys to Simplify Your Strategy and Execution</a>, that addressed Chapter <1207> and other topics. The survey questions (over 100 responses) from this webinar are instructive.
West’s <strong>Fran DeGrazio</strong>, Vice President, Global Research and Development, will present, “QbD for Elastomeric Components – A Case Study” with Mihaela Simianu, Research Advisor, Manufacturing Science, Eli Lilly and Company, on Tuesday, May 14 at 10:30 a.m. at the 2013 PDA/FDA Container Closure Components and Systems Workshop.
In 2017 there were many changes in the Chinese pharmaceutical industry. China Food and Drug Administration (CFDA) has published several new regulations and guidelines – for example, <em>Technical Requirements for Consistency Evaluation on Marketed Chemical Generic Drugs (Injection) (Exposure Draft)</em> by Center for Drug Evaluation, CFDA. This addresses the point that consistency evaluations of drugs have been extended from oral medicines to injectable medicines. This will further help to improve pharmaceuticals quality in China, and of course, be of great interest to generics suppliers.<br />
With the growing importance of <strong>gene and cell therapies</strong>, storage of <strong>vial containment systems</strong> at ultra-low temperature (-80°C) and cryogenic temperature (vapor of liquid nitrogen, i.e., -130<sup>o</sup>C to -180°C) is more common. The primary consideration for storage at such temperatures is that the <strong>vial system</strong> can maintain <strong>container closure integrity </strong>(CCI) necessary for the <strong>drug product</strong>. There are two other considerations for the vial system, considerations more critical at such temperatures than at room temperature – proper filling and proper assembly. These have been discussed in two recent publications by West scientists:<br /><br />- <em>Volumetric Capacity of Daikyo Crystal Zenith® Vials Stored in Freezing Conditons </em>(Technical Report CZ TR 2022-039)<br />- <em>Potential Over-Pressurization Issues with Ultra-Low Temperature or Cryogenic Storage of Improperly Sealed Vial/Stopper Primary Package Systems </em>(Technical Service Bulletin TSB 2020-072)<br />
At West, our goal is to partner with customers to mitigate risks of drug/packaging incompatibility, container/device and functional challenges. Although we consider critical quality attributes during development of drug packaging and delivery systems, there can be knowledge gaps of various interfaces based on the specific application of use, such as component-to-container, container-to-device, and container-to-drug.
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