Pharmaceutical companies may have to cut R&D expenditure as a result of the economic downturn, but they still can’t afford to let preclinical drug development standards slip if they want to survive. IPO Branch Pszczyna explains how its expertise as a contract research organisation could provide a much-needed shot in the arm.

With the present worldwide economic crisis in mind, it is obvious that pharmaceutical companies are struggling, with many cutting costs, particularly those concerning R&D. One solution to this problem may be using small contract research organisations (CROs) that offer competitive prices and are flexible in terms of substantive requirements. One such CRO is the Institute of Industrial Organic Chemistry, Branch Pszczyna (IPO Branch Pszczyna).

Preclinical testing is an important phase in drug development, with the main goal being to establish a product’s ultimate safety profile. Mistakes made in the determination of the toxicological profiles of candidate compounds can pay off badly in clinical trials, increasing the total cost of introducing new drugs to market. Therefore, spending fewer resources on preclinical safety testing does not seem to be a good strategy; however, in times of economic downturn and turbulence, companies tend to cut their R&D spending, especially costs that are connected directly to preclinical safety testing.

The other important issue (particularly in economic terms) is an ecological risk assessment of active pharmaceutical ingredients (APIs). It should be remembered that the presence of APIs in the environment is being reported worldwide in peer-reviewed scientific literature. Low levels of APIs are being found in drinking water, surface water (rivers and lakes), ground water and sediment. It is generally recognised that the toxicological safety of the candidate compound and its ecological risk assessment are taken into account during drug development. Ecological risk assessments are performed in compliance with the European Medicines Agency’s guideline on environmental risk assessment of medicinal products for human use (EMEA/ CHMP/SWP/4447/00).

A question emerges: how can a firm comply with all the legal and economic requirements of developing a new drug while keeping costs in the lower range? The answer may be to use a small CRO that offers expertise, competitive prices, flexibility and a high quality of work, which is often confirmed by compliance with good laboratory practice (GLP).

The pull of Poland

IPO Branch Pszczyna is a Poland-based CRO that provides preclinical services in the fields of toxicology and ecotoxicology. Founded in 1947, it is a leading R&D centre that cooperates with domestic and foreign companies on toxicological and ecotoxicological studies.

During its 60-plus years of existence, IPO Branch Pszczyna has continuously changed and developed. Its assets are highly qualified scientific personnel and technicians, modern equipment and experience amassed through completed studies. The company holds GLP certificates that entitle it to perform complex toxicological and ecotoxicological studies of APIs, and is notified to the national registry of institutions entitled to perform experiments with animals. It offers the following toxicological services:

  • acute toxicity studies (rats)
  • acute eye or skin irritation studies (rabbits)
  • skin sensitisation tests (guinea pigs)
  • sub-chronic/chronic studies, repeated dose toxicity (rats, mice)
  • neurotoxicity studies (rats)
  • reproduction toxicity studies (rats, rabbits)
  • carcinogenicity studies (mice, rats)
  • toxicokinetics studies (rats)
  • local tolerance tests (rabbits). Its ecotoxicological services include:
  • aquatic toxicology (fish; crustaceans; sediment-dwelling dipterans; duckweed; algae)
  • soil toxicology (earthworms; springtails; soil microorganisms)
  • Avian toxicology (Japanese quail)
  • fate and behaviour in the environment
  • analytical chemistry (analysis of determining the residues of chemical substances in different matrices).

The scientific studies performed by IPO Branch Pszczyna’s specialised research teams are solely for domestic companies. Its research services are exported to firms in European nations, including Germany, Belgium, Holland, Denmark, UK, Ireland, France, Czech Republic, Slovakia, Switzerland, Italy and Austria. Increasingly, it is cooperating with businesses in Australia, Japan, US, South Africa and Israel.