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Performing Viricidal Efficacy Studies under GLP
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Performing Viricidal Efficacy Studies under GLP
The onset of COVID-19 pandemic has seen a surge of products claiming viricidal / antiviral properties for reducing the prevailing infection burden. Any antivirals intended to protect public health must be registered with the national regulatory agency. As a part of the process, efficacy data under Good Laboratory Practices must be generated.

The manufacturing companies must submit chemical characterization, safety, and efficacy data generated in compliance with GLP regulations for registration purpose. Testing the products under the principles of GLP not only promotes to study their properties and/ or their safety regarding human health and / or the environment, but it also aids the development of quality test data.

Regulatory agencies have been supportive to (A) conduct more in-vitro studies to discourage the use of animals as alternatives (B) using high throughput screening techniques to generate data for safety testing purpose, thus underpinning the requirement of GLP to ensure quality and integrity to test data for product application submission.

These studies can provide vital information that can affect the success of the product. Complete virology study reports can be extensive and should include the primary data and derived data, the procedures used to get the data and information necessary to test the data.

This webinar will provide insight into testing of products for virucidal properties with appropriate application of the principles of GLP for assuring quality during the evaluation studies.

Nov 27, 2020 04:00 PM in India

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Speakers

Dr. Rahul S Fadnis
Head, Viral Testing Facility @Syngene International Ltd
Dr Rahul Fadnis pioneered setting up of First GLP certified Virus Clearance and Testing Service Laboratory in India and has several publications in peer-reviewed journals and patent to his name. Rahul is an experienced biotech professional in Viral Safety, Clearance and Vaccine Development. Rahul’s work focusses on conducting antiviral efficacy studies, viral clearance studies on the downstream manufacturing process for recombinant proteins, novel and biosimilars. In his previous roles, Rahul holds experience of conducting the cell bank characterization studies on the mammalian cell banks expressing therapeutic recombinant proteins. Actively involved in development of viral assays for in-vitro and molecular based platforms for detection of retro and adventitious viruses from recombinant protein products expressed in mammalian systems. Rahul has been instrumental in development of sensitive assays for detection of residual DNA from protein product intermediates.