Chinese CRO Partnerships Focus on Bioavailability, PK/PD Analysis

04-Mar-2013 - Last updated on 04-Mar-2013 at 10:57 GMT

Related tags Crystal

Contract drug developer Particle Sciences has recently chosen China-based CRO Crystal Pharmatech to analyse the bioavailability and material properties of its developing compounds, and the collaboration may turn into a joint venture.

“Particle is as nimble as we are as a company, about the same size, and just as dedicated to cutting-edge science,” Robert Wenslow, vice president of business development at Crystal Pharmatech, told Outsourcing-Pharma.com. He said he’s meeting with Particle every month in Pennsylvania and the partnership “may blossom into a joint venture,” though there’s no timetable for that to occur.

Crystal, which is comprised of ex-Merck employees, will help Particle analyze its low-solubility compounds earlier so they “don’t get burned” in their first-in-human studies, Wenslow said. He noted the gap in the market of companies helping smaller biotech companies and small-molecule developers analyse bioavailability when bringing new compounds into humans in clinical trials.

“If a company gets an early read on a low-solubility compound, there are between 15 to 20 types of options to increase solubility,” such as salt formation and nano-milling, but often times smaller companies don’t know what types of questions to ask, Wenslow said.

Over the past five years, approximately 65% of pharmaceutical compounds under development have been sparingly soluble to almost entirely insoluble in water, according to Crystal.

And Particle will leverage its own expertise in formulating APIs and its partnership with Crystal to push further into the Chinese market, Wenslow said. But he noted that Crystal is running more of a Western company in China than a Chinese company.

For instance, Crystal pays its employees more than local companies and its outsourcing prices are “not really better than the other competitors” in Western countries, though the focus is on quality, Wenslow said. And the start-up costs in China are considerably cheaper than elsewhere.

He added that Crystal is the only China-based CRO that can deal with solubility issues for developing compounds.

PK/PD Collaboration

In addition to the partnership with Particle, Crystal is also on the verge of publically announcing a partnership with China-based CRO 3D BioOptima for pharmacokinetic and pharmacodynamics modelling.

Alex Chen, CEO of Crystal, explained that in the past, companies outsourced to separate PK/PD and pre-formulation CROs, which lead to delays, inconsistent results and significant cost increases.

But Crystal will be able to leverage its partnership with BioOptima to consolidate how much larger companies have to outsource during preclinical phases.