Molecular Biotechnology

, Volume 27, Issue 1, pp 59-74

First online:

Preclinical safety testing of biotechnology-derived pharmaceuticals

Understanding the issues and addressing the challenges
  • Frank R. BrennanAffiliated withHuntingdon Life Sciences, Woolley Rd, Alconbury Email author 
  • , Leigh Shaw
  • , Mark G. Wing
  • , Christine Robinson

Rent the article at a discount

Rent now

* Final gross prices may vary according to local VAT.

Get Access


The unique and complex nature of biotechnology-derived pharmaceuticals has meant that it is often not possible to follow the conventional safety testing programs used for chemicals, and hence they are evaluated on a case-by-case basis. Nonclinical safety testing programs must be rationally designed with a strong scientific understanding of the product, including its method of manufacture, purity, sequence, structure, species specificity, pharmacological and immunological effects, and intended clinical use. This knowledge, coupled with a firm understanding of the regulatory requirements for particular product types, will ensure that the most sensitive and regulatory-compliant test systems are used to optimize the chances of gaining regulatory approval for clinical testing or marketing authorization in the shortest possible time frame.

Index Entries

Biotechnology safety testing monoclonal antibody recombinant protein vaccine gene therapy somatic cell therapy