PLOBSHEIM, France—Aimed at developing innovative state-of-the art research and development tools, KaLy-Cell, which specializes in the evaluation of hepatic toxicity and in-vitro and ex-vivo metabolism, and CiToxLAB, a leading contract research laboratory (CRO) in non-clinical research, have joined forces to meet growing demands from pharmaceutical, biotech and chemical industries for predictive tests to evaluate hepatotoxicity and perform metabolism studies during product development. Both companies have grown their footprints by partnering with others.
The aim of joint projects is the research and development of innovative drug candidates in collaboration with academic and/or industrial partners, says Prof. Lysiane Richert, scientific director for KaLy-Cell. Thus, R&D is considered a basis of future innovation and will provide the company with sustainability.
“We are particularly proud of this exciting partnership with the CiToxLAB Group, which offers testing capabilities in many preclinical models and state-of-the-art platforms in bioanalysis and metabolites characterization, along with a transcriptomic approach,” Richert stated in a news release.
“This partnership will enable us to offer clients a full range of in-vitro and ex-vivo hepatotoxicity and metabolism tests in a comprehensive and integrated manner,” Richert adds.
Dr. Jean-François Le Bigot, chairman of CiToxLAB Group, comments that, “We identified KaLy-Cell as a strategic partner given that hepatotoxicity is still one of the most common causes for terminating a candidate drug’s development process, and a significant factor in the refusal of marketing authorization for a drug or restrictions on its use.”
Predicting “potential toxicity during drug development is therefore a major issue for our clients,” Le Bigot states. “Early knowledge of drug metabolism through cellular models of animal and human hepatocytes is essential and contributes to rational choices, particularly the choice of the non-rodent species used during preclinical development.”
Founded in 2003 by Richert, KaLy-Cell is a partner in a number of European projects (such as EuroTransBio and IMI), bringing together hospitals, pharmaceutical companies and university laboratories, as well as collaborating with EURL-ECVAM, the European reference laboratory for alternatives to animal testing. Since March 2017, KaLy-Cell has participated with Karolinska Institutet on the Eurostars’ Project E!
The partnership with CiToxLAB will allow companies to evaluate hepatotoxicity and the potential effects linked to hepatic metabolism disorders at early stages and preclinical and clinical phases of development.
A coup for KaLy-Cell’s portfolio came Nov. 21, 2013 when KaLy-Cell executed a technology transfer and supply agreement with Athens, Ohio-based Diagnostic HYBRIDS for the manufacturing and distribution of hepatocytes and sub-cellular fractions from humans and several animal species, thus allowing both companies to perform collaborative research and development activities to enhance their joint product offerings.
“The KaLy-Cell partnership is an entry point into new, life science-based markets for Diagnostic HYBRIDS and takes advantage of our current manufacturing infrastructure and technical expertise in cell-based technologies,” David Scholl, company president and CEO, stated at the time.
The partnership with Diagnostic HYBRIDS created new opportunities for KaLy-Cell to rapidly expand its in-vitro hepatocyte services offering to North American markets, as well as giving its European customers much easier access to a wider range of cell-based technologies, Richert stated.
CiToxLAB has also had its share of key partners. A partnership with Madison, Wis.-based Stemina opened the door to allowing CiToxLAB to offer screening services using human embryonic stem cell models. In November, 2016 CiToxLAB announced the acquisition of AccelLAB, a Canadian CRO specializing in the preclinical testing of new medical devices and the development of new cardiac stents, valves and pacemakers.
In September 2014, CiToxLAB added the next-generation sequencing (NGS) technology into its genomics platform. Recent developments in technology made the NGS a powerful tool to deeply investigate signaling pathways and identify therapeutic and diagnostic biomarkers in oncology and CNS disorders. The NGS service complemented CiToxLAB’s existing gene chips and q-PCR based platforms, thus making CiToxLAB a one-stop shop CRO.