Catalent Pharma Solutions has announced it has broadened the scope of its multi-award winning OptiForm® Solution Suite platform to provide an efficient and seamless path from late-stage discovery to Phase I clinical trials.
Designed to make it easier and faster for small and mid-sized innovators to develop better treatments, the new OptiForm Solution Suite service will now include more comprehensive candidate screening tools; absorption, distribution, metabolism and excretion (ADME) considerations and in silico drug metabolism and pharmacokinetic (DMPK) modelling; additional bioavailability enhancing tools; materials for current good laboratory practice (cGLP); intravenous and oral toxicological studies; and current good manufacturing practice (cGMP) materials for first-in-human studies.
Built on Catalent’s experience in early phase development, which has seen the company support more than 500 investigational new drugs (IND), the new OptiForm Solution Suite integrates tools and services sequentially to deliver relevant data and an optimised development programme to support a molecule’s progress towards the clinic.
Catalent’s vice-president of science and technology Julien Meissonnier said: "To ensure a programme’s success, formulation selection needs to be guided by a phase-appropriate model that measures and evaluates the right data at the right time.
"The service provides innovators with a progressive, data-driven approach to maximise options that demonstrate in vivo efficacy and activity, acceptable safety margins in preclinical models, better downstream processing attributes, and optimal dose design for the intended patient group; supporting the selection of a development candidate with the best chances of success in the clinic and beyond."