Related Experiment Video
Updated: Aug 24, 2026

A Validatable Droplet Digital Polymerase Chain Reaction Assay for the Detection of Adeno-Associated Viral Vectors in Bioshedding Studies of Tears
Published on: July 14, 2023
Preclinical safety testing of biotechnology-derived pharmaceuticals: understanding the issues and addressing the
Frank R Brennan1, Leigh Shaw, Mark G Wing
1Huntingdon Life Sciences, Woolley Rd, Alconbury, Huntingdon, Cambridgeshire PE28 4HS, UK. BrennanF@UKOrg.Huntingdon.com
Abstract:
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.
Related Concept Videos
Preclinical Development: Overview
Drug Products: Biologics, Biosimilars and Interchangeables
Clinical Trials: Overview
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Upstream Processing
Drug Discovery: Overview

