With the use of the license for the models, QPS expects to begin offering metabolite identification, profiling, and clearance studies to North American customers before July, and to European customers in the third calendar quarter of this year.
“The demand for ‘long term liver cell culture models’ (like [Hepragen’s] HepatoPac) has been in great demand by the pharmaceutical market for several years,” Shiloh Barfield, VP of technical sales at QPS, told Outsourcing-Pharma.com. Specifically, QPS is looking to use “these models for studying the rates of metabolism in vitro versus in animal models (where data rarely correlates between species) and trying also to more accurately predict potential clinical toxicity.”
Heparagen’s product was chosen over about a half a dozen similar models, but the others aren’t “necessarily as practical or “bench-friendly,’” Barfield said. This was the one product that helps to solve a common problem of clearance values for low turnover compounds, he added.
“One of the big upsides of this model is that you’re not just using the cells for a couple of hours, it’s more elaborate and maintains the enzyme functions and can study a potential drug in vitro for weeks on end,” he noted.
“Knowing all the major drug developers worldwide, this is a very common problem and a question every company is trying to answer in their own way.”
Despite the downturn in preclinical outsourcing, there may be a space for smaller, more niche companies with unique solutions.
“In general preclinical outsourcing is lower than it was 5 or 10 years ago, but a lot of that has to do with models traditionally used,” Barfield told us. But for more difficult and specific projects, large pharmaceutical companies are increasingly turning to specialized companies such as QPS for their niche, in vitro projects.
“A lot of times those bigger CROs don’t have anything novel to offer pharma companies in the pre-clinical space,” he added.
In the preclinical drug metabolism field, this is a growing and evolving niche because of the demand for more physiologically “relevant cellular models and their subsequent study designs,” Barfield said.
The agreement provides for offerings in both North America and Europe, and it creates a marketing and sales partnership between the companies, providing for co-promotion of the HepatoPac-associated DMPK services. This agreement is the first such partnership in the field for both companies.
Dr. Zamas Lam, QPS SVP of preclinical development, said, “Our ability to offer services utilizing Hepregen’s next-generation product portfolio is another demonstration of the QPS commitment to enhancing its leadership position in the ADME [absorption, distribution, metabolism and excretion] field, providing cutting-edge, liver-based in vitro services to the pharmaceutical and agrochemical industry.”
QPS’ North American services will be offered from its DMPK department in Newark, Delaware, and its newly established DMPK Hepatic Biosciences division based at the Hamner Institutes in Research Triangle Park, North Carolina, using rat, dog, monkey and human HepatoPac products.