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Re-imagining Medicinal Chemistry: Leveraging Novel R&D, Advanced Manufacturing to Foster Regional Cluster Growth and Economic Prosperity

~ Phlow Corp. President, CEO & Co-Founder Discusses Strategy Behind ‘Continuous Manufacturing’ ~ 

By: Logan Barry, Virginia’s Gateway Region

In May 2020, the United States government signed a $354 million four-year contract with Phlow Corp., a public benefit essential medicines solutions provider, to increase American production of vital, essential medicines currently at risk of shortage, including medicines for the COVID-19 pandemic response.

Moreover, Phlow is building the nation’s first strategic reserve for “Active Pharmaceutical Ingredients,” commonly referred to as “API.”

In layman’s terms, this describes a long-term, national stockpile to secure key ingredients used to manufacture essential medicines on U.S. soil. This is one of the largest contracts to be awarded by the U.S. Department of Health and Human Services, the Assistant Secretary of Preparedness and Response and the Biomedical Advanced Research and Development Authority.

There is potential to extend the contract to $812 million for the next 10 years.

‘Continuous manufacturing’ and ‘essential medicines’ — what are they and why are they important?

Phlow, along with Civica Rx, AMPAC Fine Chemicals and the Medicines for All Institute, or “M4All,” makeup Virginia’s Gateway Region’s strategic partners who are engaged with progressing this initiative to accelerate the City of Petersburg’sAdvanced Pharmaceutical Manufacturing” campus into a regional cluster.

M4All is based out of Virginia Commonwealth University in the state capital. It is an affiliated research institute of the VCU College of Engineering.

All of VGR’s strategic partners define “essential medicines” as those which satisfy the priority health care needs of the American population to sustain life and conquer disease. Phlow is currently focusing on vulnerable essential medicines in short supply. Together, Phlow and VGR’s other strategic partners involved with the advanced pharma cluster are working on the initiative to keep the ball rolling and are re-imagining the essential medicines supply chain using a method known as “continuous-flowmanufacturing, as well as other advanced manufacturing technologies.

[Click Here to Read the First Article in the VGR Advanced Pharma Campaign Blog Series, titled: “Bringing Pharma Home — How the Vision Started”]

In the pharmaceutical industry, companies have historically made medicine using a lengthy, multi-step process referred to as “batch” manufacturing; this requires sizeable facilities, large-scale equipment and a significant number of harmful solvents to allow the maximum volume of product to be created.

Over the years, this approach has led to the offshoring of pharmaceutical production to countries where labor costs are low, raw materials are inexpensive and there are fewer environmental protection regulations. As a result, the manufacturing of essential medicines has become dangerously vulnerable to disruptions in foreign supply chains.

In response, Phlow is leveraging state-of-the-art flow technology and other advanced manufacturing processes in the domestic production of APIs and finished pharmaceutical products critical to U.S. healthcare. Using continuous-flow technology and green chemistry, Phlow is able to reduce costs and waste, improve access and availability of critical medications and offer a more environmentally friendly alternative to batch manufacturing.

Win-Win: Having continuous manufacturing processes in place to make essential medicines readily available, positively impacts the region’s quality of life — the number of jobs and the amount of capital investment produced as a result of the infrastructure and labor needed to manufacture these pharmaceuticals, strengthens economic development.

“The impact of this strategic partnership and the advanced manufacturing cluster on the resilience, reliability and quality of America’s essential medicine supply chain is substantial,” says Phlow Corp. President, CEO & Co-Founder Eric Edwards. “At Phlow, we are dedicated to advancing essential medicine solutions by building an end-to-end, U.S.-based supply chain to ensure that no patient ever has to be told that a critical medicine is unavailable due to a drug shortage or other supply chain disruption.”

“Unfortunately, due to our overreliance on a broken foreign supply chain, these life-saving medications have been in shortage. These are medications used to treat critically ill adult and pediatric hospitalized patients, including those battling COVID-19. Shockingly, these are also the essential medicines our first responders use to treat a cardiac arrest,” he explains.

Through this partnership, Phlow, AMPAC Fine Chemicals, Civica Rx and M4All are investing close to $500 million in the Gateway Region. They’re working together to create over 350 high-paying jobs, and many technical jobs.

“The medicines that we are making here today will help ensure a healthy and bright future for Americans. We are excited about the economic development opportunities that are occurring. By working together, there are significant opportunities for growth,” Edwards says.

“And it’s all happening right here in Virginia’s Gateway Region.”

Why Petersburg?

Petersburg offers a unique and conducive environment for this campus. The locality comes with significant infrastructure that has been in place for decades.

Phlow selected Petersburg and the Gateway Region because of the supportive environment. We’re leveraging existing partnerships and infrastructure to develop and manufacture critical medicines that Americans need,” Edwards points out. “We are able to respond quickly and have an immediate impact because of the experience and skilled workforce already established in this region.”

“Our plan is to continue to strengthen the region and invest in our capabilities by expanding our team, establishing new strategic partnerships and building the infrastructure necessary to make Petersburg the epicenter for essential medicine advanced manufacturing,” he emphasizes.

Pharma Reconstruction in the U.S.A.

Over a period of decades, the U.S. has lost the manufacturing of some of its most critical industrial bases, including APIs for essential medicines and finished dosage forms for these medicine products.

“Phlow and the strategic partners involved in this cluster are bringing back this critical industrial base here to the U.S.; we’re bringing back domestic development and manufacturing of these essential medicines that have been lost and are primarily manufactured in foreign nations; and we’re bringing back an important manufacturing footprint,” Edwards says.

The industry, he explains, has reached a tipping point. In part, because of what this country experienced throughout the COVID-19 pandemic. America has seen many of its pharmaceutical supply chains that were disparate and involved complexity being offshored.

“We’re now seeing a renewed interest and commitment by private industry and the U.S. government to rebuild critical pharmaceutical industrial bases in the United States of America,” he highlights, explaining how “this includes the essential medicine manufacturing industrial base and what we hope will be a catalyst for widespread advanced manufacturing adoption by the pharmaceutical industry, domestically.”

Impacts of Drug Shortages

For too long, America has been suffering from a huge challenge — drug shortages. These challenges impact some of the nation’s most vulnerable populations, including children.

“When we got started on this project, we were in a situation where family members would call 911 and an ambulance would arrive, and they couldn’t even be guaranteed to have the critical essential medications on that ambulance in the drug box to treat their loved one … “

“ … That can’t happen in America. It’s been deeply personal to me. I put my white coat back on as we got this entire endeavor started, and I shadowed a leading pediatrician and neonatologist at one of the leading children’s hospitals, and I watched as a child died from not having access to an essential medicine that was available just three years ago. This is America. We can do better,” Edwards maintains.

Phlow’s role through this transformational partnership is to bring back these key, critical essential medicines, many of which have been lost to overseas manufacturing and have struggled with quality challenges. They are bringing back high quality, affordable and state-of-the-art advanced manufacturing by transforming the way these medicines are made using continuous manufacturing processes.

“This cluster will create high paying jobs and foster economic prosperity in a region known as a power player in the advanced manufacturing sector. We can make that happen once again, and we’re doing it right now,” Edwards said.

About VGR’s Advanced Pharma Campaign:

Virginia’s Gateway Region Economic Development Organization (VGR) is excited to report that the region is well on its way to becoming a transformational Advanced Pharmaceutical Manufacturing cluster. In a post-COVID-19 world, the importance of drugs being made here in the U.S. has never been more relevant. Thanks to a unique public–private partnership between industry, academia and government, advanced manufacturing of essential pharmaceutical ingredients in the region will help ensure reliable access to affordable and quality medicines that will benefit citizens for years to come. To Learn more, visit VGR’s Advanced Pharma Campaign landing page, at: www.GatewayRegion.com/Rx.