Today’s blog is written by Chuck York, VP of Manufacturing Operations at Promega.
Coronavirus SARS-2-CoV continues to fuel unprecedented demand for COVID-19 related products. Once a term relegated to virology research labs, “coronavirus” is now a household term and a global crisis that has upended lives, disrupted entire economies and shaken our sense of normalcy.
Clinicians, researchers, government officials and the general public are understandably concerned about the availability of reagents for coronavirus testing. At Promega, we are hearing the needs and concerns of our scientific colleagues and partners, and we are doing all that we can to help alleviate them.
At Promega, we are hearing the needs and concerns of our scientific colleagues and partners, and we are doing all that we can to help alleviate them.
As a global company with thousands of products, we have been meeting customer demand in response to market dynamics for decades. Our long-term approach has served customers well. Our efforts to provide support for the COVID-19 response began in early January, with our work with our colleagues and customers in China. We are applying what we’ve learned to propel us forward in the most efficient way now.
We continue to increase production of all COVID-19 related reagents and instruments due to an unprecedented increase in global demand. Production lines that were running one shift 5 days a week are now operating 3 shifts seven days a week, and we continue to take measures to increase our manufacturing capacity.
This blog was written with much guidance from Jennifer Romanin, Senior Director IVD Operations and Global Service and Support, and Ron Wheeler, Senior Director, Quality Assurance and Regulatory Affairs at Promega.
A Trip Down Memory Lane
Back in the day when we all walked two miles uphill in the snow to get to our laboratories, RNA and DNA extraction was a home-brew experience. You made your own buffers, prepped your own columns and spent hours lysing cells, centrifuging samples, and collecting that fluorescing, ethidium bromide-stained band of RNA in the dark room from a tube suspended over a UV box. Just like master beer brewers tweak their protocols to produce better brews, you could tweak your methodology and become a “master isolater” of RNA. You might get mostly consistent results, but there was no guarantee that your protocol would work as well in the hands of a novice.
Enter the biotechnology companies with RNA and DNA isolation kits—kits and columns manufactured under highly controlled conditions delivering higher quality and reproducibility than your home-brew method. These systems have enabled us to design ever more sensitive downstream assays–assays that rely on high-quality input DNA and RNA, like RT-qPCR assays that can detect the presence of a specific RNA molecule on a swab containing only a few hundred cells. With these assays, contaminants from a home-brew isolation could result in false positives or false negatives or simply confused results. Reagents manufactured with pre-approved standard protocols in a highly controlled environment are critical for ultra sensitive tests and assays like the ones used to detect SARS-CoV-2 (the virus that causes COVID-19).
The Science of Manufacturing Tools for Scientists
There are several criteria that must be met if you are
producing systems that will be sent to different laboratories, used by
different people with variable skill sets, yet yield results that can be
compared from lab to lab.
Depending on your viewpoint, source of information and tolerance for risk, this can be a frightening time for persons all over the planet. The level of disruption to daily life that we’re all experiencing due to COVID-19 is unprecedented.
We are all either not working, working from home and away from our normal offices, or in some cases working many more hours to cover for sick coworkers and caring for SARS-CoV-2-infected persons.
But there is good news if you find that information is power. We hope that some information about the testing being used in the US for this novel coronavirus might be fuel for you, empowering in terms of information.
What is the Name of the Virus, and the Disease? Since this is a global pandemic, the World Health Organization was instrumental in naming the virus and disease. From this web page: the disease is called COVID-19.
The coronavirus responsible for this disease is SARS-CoV-2.