Validation of a biological manufacturing process requires that adventitious viral contaminants be destroyed or purified from the final product. Of concern are a variety of viruses which may originate from non-human animal ingredients such as serum. Of course human viruses such as HBV and HIV are also of concern. In other words manufacturers of products derived from animal or human tissues, blood products and some medical devices are required to assess the ability of their purification and manufacturing processes to produce a product that is safe for use in humans. Gibraltar Laboratories performs the studies which are intended to provide empirical evidence of the effectiveness of the critical steps of the manufacturing process to inactivate or remove viruses. Such validation requires highly specialized facilities and staff to carefully perform. Without a successful validation regulatory authorities such as the FDA do not feel there is enough safety data to allow approval of an investigational new drug (IND) submission for human use. Gibraltar Laboratories has a secure collection of many important challenge viruses that demonstrate effectiveness when the mechanism of action is heat or chemical For example. Bovine Diarrheal Virus, Polio Viruses, Adeno Virus, Parvo viruses, DHBV, Herpes simplex virus type 1 or 2, Human Immunodeficiency virus 1, Human rhinovirus, Equine Influenza, Porcine parvovirus, Pseudorabies, Reovirus type 3 Simian virus 40, Sindbis virus, Transmissible gastroenteritis virus , Vaccina virus and Vesicular stomatitis virus.
In each critical step Gibraltar Laboratories determines the log reduction value. We hope that our sponsor’s process will be highly effective having an overall log reduction value of 4-6 logs or more! The removal of prion like agents is an additional consideration that is sometimes needed and can be discussed separately, i.e., transmissible spongiform encephalopathy (TSE) agents.
Gibraltar also performs viral experiments to demonstrate the in vitro effectiveness of anti-viral drugs and disinfectants intended as research or support regulatory submissions to US FDA and EPA.