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Prefilled syringes, and prefilled syringes with auto-injectors, continue to dominate the landscape. However, there has been an uptick in the evaluation and use of cartridges in on-body injector systems. The growth of these kinds of products reinforces the need for solutions to deliver larger volumes of biologic products to patients in a simplified manner. The trend from intravenous administration to subcutaneous administration helps to facilitate this patient-friendly option.
At the February 2022 West webinar,Demystifying Essential Performance Requirements (EPRs),several survey questions were posed to attendees to understand boththe industry’s knowledge of EPRs, and how prepared they are tomeet them. A question regarding what injectable combination products(CPs) are being developed revealed the following trends (Figure1):
Now that these innovative CPs are available, the challenge is tomeet the needs of the regulators in order to facilitate approval foruse in the market. This challenge was the focus of the secondquestion (Figure 2). Key industry concerns include development of anappropriate testing strategy, building the correct data sets, andpreparing documentation to support the regulatory filing.
The webinar specifically focused on how to identify EPRs and relatedcontrol strategies. Having a comprehensive testing plan is criticalto regulatory submission. The underpinning of all these activitiesis a risk-based approach to understand the constituent device andfinal combination product EPRs. EPRs are defined as: a subset ofdesign controls that relate to assuring that clinical performance ofthe device itself is adequate to meet the combination productperformance intended at the point of dosing.1
The third question revealed that approximately half the attendeesdid not utilize a risk-based process for identifying EPRs (Figure3). Not using a risk-based approach increases the potential forfailure. Challenges will arise in addressing regulatory questions onsubsequent performance testing issues if up-front work is notcompleted effectively.
EPRs and their associated control strategies are an extremelyimportant piece of the data/documentation that is assembled as partof the CP submission process. The control strategy should provide acomplete overview of all points of control relating to the CP andits constituent parts.
More details associated with EPRs and control strategies can befound by viewing this webinar atUnlocking the Mystery of Combination Product Essential PerformanceRequirements.
Reference
1. Diane Harper,Applying ICH Q12 to Combination Products. American DrugDelivery & Formulation Summit. 2019
West is now celebrating the one-year anniversary of its Integrated Solutions initiative, known as Simplify the Journey™. Throughout 2019, we socialized the program through marketing materials and face-to-face conversations with customers. Now it’s time to reflect on the lessons we’ve learned — and to look forward to the opportunities on the horizon.
Part 1 of this two part blog series, gave a high-level overview of the new ICH guideline <em>Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management</em>. In part 2 of this blog series, some of the key takeaways will be discussed in more detail. <em>Q12</em> is intended to help companies demonstrate increased product and process knowledge, and understand which post-approval changes will require a regulatory submission, as well as the level of reporting for each category.
The first thought that you may have when you hear the word “rubber” is natural rubber – a poly-isoprene-based polymer, which has as its origination the latex fluid drawn from rubber trees (most prominently in Indonesia and Malaysia). Although natural rubber has been used in the past for pharmaceutical applications, potential issues with latex allergies resultant from proteins from the original latex, have led to the almost complete adoption of synthetic rubber.<br />
Employees from The Tech Group’s Phoenix, Rockford, Scottsdale and Tempe West facilities raised more than $72,000 for Upward Children and Families as part of the 2013 West without Borders fundraising campaign.
<a href="/blog/2017/october/west-on-the-road-eschweiler-germany-part-1">In Part 1 of our West on the Road – Eschweiler series</a>, we learned about the high-value products produced in our Eschweiler, Germany facility and how this dedicated team of manufacturing experts supports customers in their mission to bring critical medicines to patients. In Part 2, we learn from Lukas Buglowski, Team Lead of Engineering, Envision, about how a focus on quality is both a shared mindset and built into every step of the manufacturing process in Eschweiler. Buglowski shares the pride his team feels knowing that they are producing high-quality products that will not only meet customers’ expectations, but more importantly, ensure patient safety, and how this builds trust and makes for a great team dynamic.
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