Objectives

Preclinical testing as well as potency evaluation of biological products is dependent on the establishment of the accepted international in vitro and in vivo models. The platform aims to:

Function as a national preclinical testing platform for qualitative and quantitative preclinical studies for research institutions and companies.

  • Perform safety pharmacology, pharmacokinetic and selected toxicology studies for new compounds and/or formulations.
  • Perform potency & safety batch release assays of biologically-based products.
  • Develop, establish and maintain models as it relates to infectious diseases, chronic conditions, neurobiology and treatment of a variety of disorders.
  • Establish the infrastructure and skills set required for performing the various in vitro and in vivo studies during the preclinical phase of drug development.
  • Create an enabling environment to attract both local and international customers to use of the facility.
  • Introduce GLP status and cGMP status respectively to the sections where such level is required, including staff training in GLP and cGMP guidelines.
  • Create an infrastructure that could enable South Africa to play a significant role in the production of drugs and phyto-medicines.

Vision and Mission

Preclinical drug development is a scarce and critical knowledge field in South Africa. The development and manufacturing of relevant medicines for infectious and chronic diseases relevant to our society within the financial constraints are challenging.  It requires that novel pharmaceutical products and biologicals such as vaccines are developed and produced locally. The Platform aims to meet the stringent regulatory requirements to comply with international pharmaceutical best practices and to deliver a world class service in preclinical drug evaluation.

Outcomes

  • A complete value chain in the drugs/phytomedicines industry.  The NWU forms a starting point.
  • South Africa will be in a position to respond timeously and more comprehensively to the need to produce therapies for African or “Third-World” diseases.
  • An institution that is accessible to all scientists who may require such research services at reasonable cost.
  • Protection of South African intellectual property (IP).
  • The enhancement of the capability of South Africa to participate in cutting-edge research