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Scientific Insight Enables Risk Mitigation: Why West is By our Customers’ Side
As regulations increase across the pharmaceutical industry, reliable scientific evidence is needed to support the decisions being made during the drug development process in order to achieve the safe delivery of medicines to patients.
Recent regulations around issues such as particulate and heavy metals, require a strong understanding of the testing and analysis to move drug products to the market.
Collaboration with strategic suppliers is critical to managing issues associated with bringing a sensitive drug molecule to market. By supporting our customers from molecule to market, West works to build a close partnership that can provide the scientific analysis, data and regulatory support needed to mitigate risk, speed drug development, and get drug products to market to support patient health.
No matter what challenges our customers face during the drug product life-cycle, chances are West has faced them before. With nearly a century of industry leading experience, West may already have the answers you need, and if not, we can develop a scientific approach to find what you’re looking for. Working together, we can address issues quickly and effectively, helping to mitigate risks as early as possible in the development process by helping customers navigate regulatory and technical challenges.
To learn more about how West can help, check out our video here on our Integrated Solutions Program page.#WestByYourSide
Diane Paskiet, Ph.D., Director of Scientific Affairs, will present “Biopharmaceutical Quality: Factoring Extractables into the Risk Equation” at Cambridge Health Insitute’s 14<sup>th</sup> Annual PepTalk 2015 conference on January 22-23, in San Diego, CA. The program, which was co-developed by Thomas Egert, Research Scientist, Boehringer Ingelheim GmbH & Co. KG, will focus on risks to quality posed by materials that contact biologics during manufacturing, storage and those associated with the final packaging configurations can pose risks to quality.
I’m coming towards the end of my 19th year at West in May this year. Today, I am the Global Facility Energy Manager, working as part of the Global Facility Engineering team. Previously, I joined the West Dublin site as a Maintenance Technician and after two years I was promoted to Facilities and Maintenance Manager.
Why is meeting customer needs no longer enough? In an expanding global economy with international competition, meeting customer needs is simply not enough. Meeting customer needs leads to customer satisfaction but does not lead to customer loyalty, which is what keeps companies in business.
<p style="text-align: justify;">Most cancer drugs are hazardous. OSHA, NIOSH and USP regulations, enacted to protect healthcare workers from exposure, stipulate the need for safe delivery. Needle-free devices, such as spikes, can help to meet this need. However, traditional spikes used in infusion systems have posed a concern with small drug vials — stopper push-in by spike incidents can occur.</p>