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Microdermics will focus on product development and clinical activities of new drug delivery methods, while Vetter’s primary role will be in the fill and finish aspect.
Contract development and manufacturing organization (CDMO) Vetter and medical-device company Microdermics have entered into a strategic cooperation agreement to develop innovative microneedle drug-delivery systems. Microneedles provide an alternative to the classical needle injection. One of the challenges in commercializing this novel drug-delivery approach, however, is the limited investment in scalable aseptic manufacture at later phases of development. For this reason, Vetter and Microdermics have joined forces to enable the progress of the microneelde technology to late-stage process development and device manufacture on a commercial scale.
Microdermics has developed a novel commercially scalable, low-cost, customizable, metal, hollow microneedle platform for delivering vaccines and biologics into the intradermal space. The company says its microneedle system provides improved comfort and pain-free treatment to patients. Microdermics has successfully demonstrated the initial safety of its microneedle system. There are currently plans for Phase 1 human clinical trials for vaccine and therapeutic delivery to be initiated in 2017.
Under the agreement, Microdermics will focus on product development and clinical activities of new delivery methods for existing commercial products. The aim is to provide innovative methods for product differentiation via a novel intradermal delivery system, as well as pursue product lifecycle extensions.
Vetter’s primary role will be in the fill and finish aspect, but the CDMO will also jointly conduct proof-of-concept studies on selected drugs and drug classes. Vetter will jointly design devices for testing, including how to integrate the microneedle technology into injection devices. Vetter’s offerings include a combination of device development and associated drug product manufacturing and packaging services.