Peru's biotechnological company BTS Consultores will produce low-cost COVID-19 molecular test kits after receiving the Certification of Good Manufacturing Practices (BPM) granted by the
General Directorate for Medicines, Supplies, and Drugs (Digemid).
In May this year,
San Marcos University's biologist Luis Saravia and his team of scientists took on the challenge of producing the COVID-19 molecular test kits.
However, there was no place to scale and produce them in Peru, that is, the country lacked a manufacturing plant —governed by good manufacturing practices— for this type of technology.
At the same time, the BTS Consultores team managed to implement the first manufacturing plant for in vitro diagnostic medical devices with its own funds.
Peru's first manufacturing plant for in vitro diagnostic medical devices is located in Downtown Lima and has been operational —with the authorization of Digemid— since December 11.
"Now that the plant is operational and the kit is ready to be produced, we hope to get the emergency health registration as soon as possible and be able to market it," said Luis Saravia, leader of the CavBio project.
Good manufacturing practices are guidelines required by the regulatory agency (Digemid) to market pharmaceutical and medical device products or, in this case, in vitro diagnostic medical devices.
(END) MFA/SPV/RMB/MVB
Published: 12/23/2020