Toxi-Coop
Continuous Learning to Gather More from Less

Pharma Organizations’ increase in R&D activity has resulted in outsourcing studies to CROs because of cost-effectiveness. CROs must provide technical and scientific support to every aspect of the drug discovery and development process. One of the main ways in which CROs can support their sponsors is by focusing their studies on the regulatory requirements and following technological and scientific advances in the entire process. This has been the cornerstone of Toxi-Coop Plc, a Budapest-based Hungarian non-clinical CRO.

For over 35 years, Toxi-Coop Toxicological Research Centre Plc. has been providing an extensive list of services for the registration of regulated substances to pharmaceutical, agrochemical, and chemical markets. The company is a GLP (good laboratory practice) offering GLP, OECD, and FDA compliant preclinical in vivo and in vitro toxicology testing for pharmaceuticals, cosmetics, biocides, medical devices, food and dietary supplement ingredients, chemicals (REACH) and agrochemicals. “We focus our studies on the regulatory requirements not only for pharmaceuticals but for other chemicals or protein,” says Dr István Sebestyén, toxicologist, CSO, Toxi-Coop and Scientific Secretary of the Society of Hungarian Toxicologists. “We try to improve the field of in vitro studies, to save the use of experimental animals using reduced numbers of animals for more information.”

The company caters to the non-clinical needs of pharmaceutical, biotechnology and medical devices companies. Toxi-Coop helps its clients adapt to the continuous changes in the regulatory environment and follow the fast technical developments, which are reflected in data requirements for product registrations.

We try to improve the field of in vitro studies to save experimental animals using reduced numbers of animals for more information

Toxi-Coop Plc engages its clients with high standards on scientific excellence, the well-trained staff with knowledge and practice accumulated over many years, and flexibility in planning and performing the studies on time.

Based on the GLP requirements, Toxi-Coop has continued educational courses for their scientists and continuously participates in SOT meetings in the US and Eurotox meetings in Europe. This has enabled the company to develop new and more convenient treatment methods for specific drugs. Take the case of sublingual dosing. The company has developed the study protocol, treatment methods and bioanalytical analysis for rodents like mice, rats and rabbits to provide toxicology and toxicokinetic data for preclinical development of these types of drugs.

In addition, Toxi-Coop was able to extend support to the manufacturers of smoke flavouring in Europe when in February 2021, EFSA (European Food Safety Authority) published updated guidance on the scientific data that applicants need to include in their dossiers for the authorisation of a new smoke flavouring as well as for the renewal or modification of existing authorisations. As per the guidance, organisations must submit additional study data for registration and should follow a new approach for evaluating the genotoxicity potential of a complex mixture than it was required earlier. Toxi-Coop helped the manufacturers interpret the new regulatory requirements and offer solutions for tiered genotoxicity investigations including QSAR evaluations, in vitro or in vivo tests. The company supports the manufacturers with the newly required combined repeated dose/reprotoxicity studies and the extended one-generation study or the combined chronic/carcinogenicity studies.

This expertise has enabled Toxi-Coop to focus on developing new equipment and methodologies on analytical chemistry. The company is focused on gathering new information and implementing and improving the combination methods in the in vivo studies to reduce the number of experimental animals and gather more information through single animal experiments.