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It is essential to consider lifecycle management during the development of new drugs – especially in the evolving area of biologic drugs. The market demand for both ease of use, and patient-centric at-home administration, is driving the need for innovative container systems and delivery devices. Typically, drugs are launched in vials; continuous development often then enables launch in other formats, such as pre-filled syringes and cartridges. West is committed to easing this movement from container systems to delivery devices through its NovaPure® component portfolio of elastomer closures. NovaPure stoppers and plungers offer best performance and highest quality. Developed with Quality-by-Design principles, they use FluroTec® barrier film and B2 coating technologies.
The NovaPure component portfolio covers multiple aspects of lifecycle management. This includes stoppers for vial systems (standard 13mm and 20mm sizes, for serum and lyophilization applications), plungers for pre-filled syringes (1mL long and 1-3ml standard sizes), and cartridges (3mL size). By selecting components with the same material composition, risk in adopting new formats is reduced, as understanding of drug compatibility and interactions has been evaluated already. The NovaPure component portfolio is offered as both ready-to-sterilize and ready-to-use, and in various packaging (STERILIZEABLEBAG™ and rapid transfer ported bags). Highest quality and easy lifecycle management promote the best patient experience; for these reasons, NovaPure products are the right solution. For more on how West can provide support, please contact an Account Manager or Technical Account Specialist.
NovaPure®, FluorTec®, Westar®, Envision™ and STERILIZABLEBAG™ are trademarks and registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
FluroTec® and B2 coating technologies are licensed from Daikyo Seiko, Ltd.
“There is no disease so rare that it does not deserve attention.” This statement from Orphanet, a portal for rare diseases and orphan drugs, makes that point very clearly. For patients suffering from a rare disease, orphan drugs and the special attention that they receive during the drug review and approval process can be both life changing and saving.
West’s SmartDose® platform has been selected as a finalist in the 19th Annual <a href="http://mdeawards.mddionline.com/">Medical Design Excellence Awards</a> (MDEA) competition. Considered the medtech industry’s premier design competition, MDEA recognizes significant achievements in medical product design and engineering and the many people behind the scenes—engineers, scientists, designers and clinicians—who are responsible for the cutting-edge products that are improving patient healthcare.
The complexity of bringing a combination product, such as an on-body delivery system (OBDS), to market cannot be overstated. Changing or unclear regulations are often cited by the industry as a major source of confusion which contributes to that complexity. However, continuous incorporation of updated standards and newly issued guidance documents during the development process can reduce risk, improve patient safety, save time and headaches when the submission date ultimately approaches.
Unanticipated incompatibilities between the drug product and a closed system transfer device (CSTD) delay therapeutic delivery to the patient. Considering the CSTD with the drug product and even co-packaging the drug product with an optimal FDA-approved CSTD will positively impact drug product therapeutic performance and ultimately patient care.
When converting a drug product from its initial container closure system to a prefillable syringe system or device, component elastomer formulations and sterilization mode equivalency can help ease the transition, minimize regulatory filing times and mitigate risk for pharmaceutical manufacturers.
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