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Industry meetings continue to reinforce the changing landscape of the drug pipeline and the influence of biologic drug products in driving this change. At the recent DCAT Week, hosted by the Drug, Chemical and Associated Technologies Association, Josef Bossart, of PharmaCircle, provided an excellent overview of historic trends and current forecasts.
In 2016, FDA approvals for oral dosage forms only slightly exceeded those of injectable dosage forms (50 to 44). This trend for increased numbers of injectable products to receive approval is expected to continue; between 2017 and 2022, the largest number of products in development are anticipated to be injectable. This clearly substantiates the need for injection technologies that facilitate both patient ease of use and compliance.
The use of injection technologies is driven by the ability to deliver biologic drug products (e.g., monoclonal antibodies), and the ability to be coupled with delivery technologies such as auto-injectors that enhance both convenience and compliance. Consideration of delivery systems needs to be made early in the drug product development process, from the human factors, development and clinical perspectives. Such consideration will substantially improve the chances of successful delivery of challenging molecules – ultimately delivering fit-for-purpose combination products for patient use.
Please visit the West Knowledge Center to view the full presentation.
Microneedles have been around for the past two decades; however, recent advances in technology have enabled their manufacturing in a variety of different forms and at lower cost than previously possible. The technologies, ranging from hollow, solid, coated to dissolving, have captured the interest of many vaccine and drug manufacturers as an alternate form of delivery primarily due to the potential advantages associated with transdermal and intradermal delivery.<br />
We are living in very unpredictable times. The virus SARS-CoV-2 is keeping the global pharmaceutical industry, including regulatory agencies, very busy. The whole industry is working together in the development of treatments and vaccines. The process of getting these treatments approved and to patients as quickly as possible requires the undivided attention of regulatory agencies, such as the FDA and EMA. As a result, the following deadlines have been extended for certain other requirements.
A good elastomer stopper for a vial container system needs to have the right properties. These properties are largely determined by the elastomer formulation, which comprises the base elastomer, fillers, plasticizers, and curing agents. The interplay among these components is crucial, as they determine performance. For example, hardness is affected by filler type and level, as well as by curing agent and level. West understands these issues, and therefore is able to develop formulations to offer maximum performance. An example is the formulation 4040/40, which was designed according to quality-by-design (QbD) principles.
<p style="margin: 0in 0in 10pt;">The new regulation “Bundling Review and Approval of Packaging and Excipients with Drug Products” announced by the China Federal Drug Administration (CFDA) on August 10, 2016, has generated both interest and concern. While the CFDA has published several related guidelines in an effort to address questions, many still persist. </p>
Working at West means being part of a culture of giving and working by the side of the communities where we operate. Our team members are passionate about making a difference and donate considerable time and resources through our corporate giving and volunteer programs. West’s giving strategy focuses on three elements: corporate giving through direct charitable gifts made by West Pharmaceutical Services, Inc., scholarships and matching gifts awarded through the Herman O. West Foundation, an independently managed 501(c)(3) entity and our team member-led giving program, West without Borders*.
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