To offer contract product development and manufacturing of hormone-eluting devices
Particle Sciences Inc (PSI), a US contract research organisation, is to collaborate with Chemo, a multinational manufacturer of APIs and Finished-Dosage-Forms (FDF), to offer complete contract product development and commercial manufacturing of hormone-eluting devices.
Bethlehem, PA-based Particle Sciences has been working with Spain-headquartered Chemo for several years on a number of hormone-based polymeric combination products.
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 do the development work, establishing design, performance, scale up parameters, analytic and QC methods and producing clinical trial materials in its cGMP facility.
Chemo will assume production and fulfilment roles in mid to late clinical testing and through to commercialisation.
The companies are already successfully working on several products under this model with the first ones having entered the clinic last year.
Lucas Sigman, chief executive of Chemo’s US subsidiary, said: ‘Particle Sciences has a top tier technical team and an excellent facility. 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.’