Manufacturing Diagnostics 101

Dr. Aimorn Homchan, School of Biomolecular Science and Engineering, Vidyasirimedhi Institute of Science and Technology (VISTEC), Rayong, Thailand, Department of Biochemistry, Faculty of Science, Mahidol University, Bangkok, Thailand

The collateral cleavage activity of CRISPR-associated nucleases, particularly Cas12 and Cas13, has been used as a basis for nucleic acid detection, including that of SARS-CoV-2. Common designs of CRISPR diagnostic methods combine an isothermal amplification step with a Cas-based detection step for maximal sensitivity and specificity. While CRISPR-based detection holds promise for use in low-resourced settings due to its accuracy, ease of use and minimal equipment requirement, the technology uses many biomolecular components, several of which are costly and proprietary. Here, I will describe our team’s efforts to locally produce and formulate recombinase-polymerase isothermal amplification (RPA), while concurrently improving several characteristics of RPA and CRISPR-based detection, particularly for the detection of SARS-CoV-2.

Bruno Di Mauro, President, and Luciano Brum, Biotechnologist, of Farmacoop

Farmacoop is a recovered company formed from Roux Ocefa Laboratory who went bankrupt after more than 80 years of work. The employees demanded to continue working and were able to create the cooperative. Through rebuilding the production and manufacturing plants, Farmacoop were able to receive certification to manufacture medical devices. Now, Farmacoop is developing a SARS-CoV-2 diagnostic test, named FarmaCov, using IgG antibodies to track positive cases as a complimentary assay to PCR that does not require highly skilled technicians.