At 50, Microbiologics is Still Setting the Standard and Inspiring Confidence in Science

Microbiologics Egg_Microbiologics

A Microbiologics scientist candles an egg to observe the location of veins and air pockets to determine an injection site of influenza virus inoculum. Microbiologics is one of a very few organizations highly skilled at growing high-titer viruses in eggs.

Microbiologics, Inc. commemorated its 50th anniversary in 2021 by playing a key role in helping the world manage the COVID-19 pandemic. With its virology assay development, testing services and molecular IVD controls, Microbiologics is helping to test the products and compile the data that should eventually lead the planet out of the greatest crisis in a generation.

After starting out as a water testing company in 1971, St. Cloud, Minnesota-based Microbiologics transitioned into prepared media (the media in which microorganisms are cultured) and then developed a process for freeze-drying microorganisms to use as quality controls, for which it became best-known. Today, Microbiologics has evolved into a cutting-edge biomaterials company with a portfolio comprising the original culture media-based microbial controls along with molecular infectious disease controls, virology and antibiotic testing services.

While many aspects of the business have changed over the past fifty years, Microbiologics CEO Brad Goskowicz told BioSpace that some things remain the same.

“The entrepreneurial spirit that was there back in the 70s and 80s is still here today as we enter into new marketplaces with new products and new technologies,” he shared.

One of the company’s hottest segments is infectious disease molecular standards used for research and quality control (QC) of in vitro diagnostics (IVD). These molecular standards contain the target organism(s) in an inactivated, non-infectious state which eliminates the need to grow and maintain live cultures. This is particularly helpful for infectious diseases that are especially difficult or dangerous to grow, such as SARS-CoV-2. With the increased demand for rapid and sensitive tests for SARS-CoV-2, Microbiologics moved quickly to add SARS-CoV-2 and its variants to their line of molecular standards. Nucleic acid-based tests using PCR (Polymerase Chain Reaction) tests or other methods of amplification are currently the most trusted assessment tool for COVID-19 infection confirmation.

“Nucleic acid-based amplification methods are specific and very rapid. Traditional microbiology takes three days to a week to get an answer. Now test results are available in minutes,” Goskowicz said.

The company also provides antibody assay development services for the Biomedical Advanced Research and Development Authority (BARDA).

Microbiologics lab“Once we had shots available a year ago, the next question we really wanted to know was, how long will they last? How strong will they be? How well do they work in different populations? What data do we need on safety and efficacy to eventually go from emergency use authorization to full approval?”  Microbiologics’ viral neutralization assay services help vaccine developers know how effective their vaccines are and how long their efficacy will last.

Microbiologics’ key partners are Fortune 500 pharmaceutical companies. For a company developing a flu vaccine, antiviral or antibiotic, Microbiologics provides testing of these compounds to determine their potential efficacy and inform the optimal dosing regimen.

As society cautiously begins to open back up, the ability to develop better vaccines against influenza and other viruses will be critical.

“We're seeing a lot of outbreaks of influenza A, as well as some of B, and RSV (respiratory syncytial virus) has been around pretty much the whole year,” Goskowicz noted. “Because we've been sheltered, and we were so good at protecting ourselves in 2020, our immune systems probably aren’t tuned up as much to the normal cold and flu strains.”

When it comes to patient safety, Microbiologics understands there is no room for error. To this end, the company offers testing for an extensive range of clinical products and medical devices. A key aspect of Microbiologics’ mission is to “create the highest quality biomaterials for a safer world,” Goskowicz said. “The controls that we make are really the foundation on which all the other testing is done.”

He gave the example of a patient in the hospital being tested for pneumonia or another type of chest infection. In this case, it is essential to quickly find out whether the infection is viral or bacterial, because then the patient can be treated expediently. The tests need to be accurate because they determine the entire course of this patient’s treatment. This is where Microbiologics’ controls come in.

“That’s why a hospital will buy a specific control from us, to make sure that they can find it (the antigen), identify it, and then hopefully get rid of it,” Goskowicz said.

Creating confidence in science could not be more important today, and this is one of Microbiologics’ key mandates.

“Our products are pretty much all about creating that confidence in the science, in the testing and in the results that you’re getting,” Goskowicz said. “We are those quality control manufacturers, those standard makers. By using those, you know that your reagents are working, that your instruments or your operator are doing things correctly.”

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In order to support the growing demand for its services, particularly in the molecular controls and virology spaces, Microbiologics has been steadily expanding over the past twelve years. This began with a key site addition in Lexington, Kentucky, which handles a lot of the custom work for the company’s retail products. Next, in 2017, came a new virology center in San Diego. This was in response to a growing demand for virology testing and high-quality, high titer viral stocks. Finally, in 2019, Microbiologics added a center in Kalamazoo, Michigan, which came equipped with deep expertise in testing antibacterial and antifungal drugs and therapies.

Notably, several Microbiologics facilities possess both Biosafety level 2  (BSL2) and Biosafety level 3 (BSL3) clearance. The first entitles the facility to work with agents associated with human diseases, such as pathogenic or infectious organisms that pose a moderate health hazard, including RSV and Staphylococcus aureus (staph infections). Under a level 3 ranking, the lab is able to handle microbes that can lead to serious or lethal disease through inhalation.

The company did not try to reinvent the wheel with these new facilities, instead leveraging the knowledge already in place at these sites. “You can move a lot faster if you can find an existing business with that experience and expertise and then grow from there,” Goskowicz said.

While culture-based controls remain the largest piece of the business today, Goskowicz said, “when we look ahead five years, virology and molecular controls will be significant, maybe even more significant than the core business.”

To keep up with this growth, while maintaining the quality that is at the heart of its ethos, Microbiologics is continually looking for highly qualified team members. Goskowicz said the company is particularly seeking virologists and technologists as those divisions rapidly expand. He added that there are also opportunities in marketing, IT, regulatory and quality systems and operations. “When a company is growing as fast as we are, there is a wide variety of positions that are pretty much open all the time. As we grow, of course, there is also lots of opportunity for advancement to senior or executive positions.”

Throughout its history, Microbiologics has been adept at anticipating where science is heading and growing along with it. Along these lines, Goskowicz shared that precision medicine is the next big focus area for molecular controls, particularly in oncology.

“The types of diagnostics that are being developed there, to determine different types of tumor markers, is really the same technology as we use in infectious disease,” he explained. “So, I think the next piece for us will be to start moving into that area of precision medicine and developing the third-party controls for those new diagnostics that are helping move prevention cancer treatments ahead.” 

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