Particle Sciences Inc. and CHEMO recently announced they have formed a partnership to offer complete contract product development and commercial manufacturing of hormone-eluting devices. Particle Sciences is a world leader in the formulation, testing, and scale-up drug/device combinations and has been working with CHEMO for several years on a number of hormone-based polymeric combination products.

“In our work with CHEMO and others, it became clear there was no complete solution for companies wishing to develop and commercialize hormone-based combination products,” said Mark Mitchnick, CEO of Particle Sciences. “CHEMO is basic in many hormones, a well-respected global supplier, and has strong global marketing capabilities in WHC. Particle Sciences has the intellectual property, infrastructure, and development capabilities to rapidly get such products into the clinic. By combining our efforts, CHEMO and Particle Sciences now offer the only complete solution for combination product development. CHEMO has proven to be an excellent partner, and this is consistent with our business model of making sure our clients are positioned in the best possible competitive situation, in this case, by providing a rapid, cost-efficient path to commercialization.”

Under the agreement, the two companies will leverage each other’s strengths to provide a start-to-finish contract solution for those looking to develop and market hormone-eluting devices. Particle Sciences will execute the development work, establishing design, performance, scale-up parameters, analytic and QC methods, and producing clinical trial materials in their cGMP facility. CHEMO will assume production and fulfillment roles in mid-to-late clinical testing and through to commercialization. The companies are already successfully working on several products under this model with the first ones having already entered the clinic last year.

“Particle Sciences has a top-tier technical team and an excellent facility,” said Lucas Sigman, CEO of Chemo’s US subsidiary. “This relationship is yet another step in CHEMO’s global technology-based expansion. As an API supplier and FDF manufacturer, bringing in hormone-based combination product capabilities is a natural step and one that we are very enthusiastic about.”

Particle Sciences is an integrated provider of drug development services, focusing on emulsions, gels, micro- and nano-particulates, drug/device combination products- and highly potent compounds across all dosage forms. Through a full range of formulation, analytic, and manufacturing services, Particle Sciences provides pharmaceutical companies with a complete and seamless development solution that minimizes the time and risk between discovery and the clinic.