Development of a Validated Molecular Analytical Method to Determine the Viral Safety of F(AB´)2 Products: A Novel Application for a Well-Known Technique

AbstractThe immunotherapy agents derived from horses are biological products that allow the neutralization of clinically relevant immunogens, such as the SARS-CoV-2 virus that causes COVID-19, or the neutralization of toxins present in the venoms of snakes, spiders, and other poisonous animals. Due to their importance, detecting the adventitious virus in equine hyperimmune plasma (raw material) is an indispensable step to ensure the safety of products; it is also a requirement for commercialization and distribution. Orthogonal approaches to reduce viral contamination risk include implementing a reliable and validated system for detecting viruses and ensuring a material free of adventitious viruses. Thus, it is necessary to establish trustworthy and sufficiently sensitive analytical methods to evidence the lack of viruses to assure the safety of the therapeutic product. Therefore, in this research, an analytical method based on end-point Reverse Transcription Polymerase Chain Reaction (RT-PCR) was developed, implemented, and validated in hyperimmune equine plasma samples to detect Venezuelan equine encephalitis virus, West Nile virus, and Rabies virus.