Question

Using the SARS-CoV-2 tests, explain the processes required for scaling up production of the newer diagnostic testing in a global pandemic and regulatory processes required for use of new diagnostic tests for COVID-19 within Australia, Europe and the United States of America. This section is to describe the some of the manufacturing challenges associated with meeting the rapid demand for tests during emergency or disaster management. Diagnostic tests require regulatory approval by FDA (US), TGA (Australia) and CE (European Union). How do companies ensure product can be continued to be manufactured and distributed to meet global need during a pandemic and what short cuts exist to certify products safe for use in humans during emergency situations such as a pandemic?

Answer 1

All over the world now suffering for covid 19 virus.under pressure ,the global scientific community has developed promising tests and treatment for covid 19 in the span of just a few months.But moving medical technologies from conception to development at such an unprecedented rate comes with a multitude of hurdles.

To detect the presence of corona virus( SARS-Cover-2) from nasal and throat swabs,most of these kites have to be analyzed in centralized laboratories,with trained personnel.

Cobra biologics Inks agreement with AstraZeneca for manufacture of covid -19 vaccine candidate cobra biologics signed a supply agreement with AstraZeneca to provide GMP manufacture of the adenovirus vector- based Covid19 vaccine candidate AZD1222,previously know as ChAdox1n-cover-19. The production agreement is part of AstraZeneca's recently announced.

Vaccine should be first manufacturing U.K September 2020.