Phlow co-founder and CEO Eric Edwards (Photo courtesy Phlow)
An advanced manufacturing hub is in the works in the south metro Richmond area, built around a multimillion-dollar project to build a national stockpile of essential medicines and to ramp up production of crucial pharmaceuticals and the ingredients from which the finished products are made. Richmond-based corporation Phlow is a focal point of the effort, receiving $354 million in federal money in May 2020.
Phlow is working with partners including the Medicines for All Institute at Virginia Commonwealth University, Civica Inc. and AMPAC Fine Chemicals. In January, Virginia Gov. Ralph Northam’s office announced a $124.5 million project by Civica that will lead to 186 jobs in Petersburg.
Richmond magazine talked earlier in the week with Eric Edwards, the co-founder and CEO of Phlow, about its role in responding to the COVID-19 pandemic, the interrelations and interplay of the various entities in these projects, the work to change how essential medicines are created and stored, and the importance of the project to the nation and to the metro Richmond region in particular. Responses have been edited for length and clarity.
Richmond magazine: You’re almost a year into the $354 million federal contract. Also, Phlow ramped up and has played a part in creating 2 million doses of generic meds for COVID-19 patients. Where are you now in terms of COVID-related work, what’s the impact of the pandemic on production, and what you do for the rest of the year?
Eric Edwards: Phlow received a large federal government contract to really focus on two areas. First, to help secure the country’s essential medicine, and secondly, to rebuild this critical industrial base that’s been lost over decades, to be able to manufacture these essential medicines end to end, from chemistry all the way to the finished dosage form so that we can get it to the patients at the bedside.
So right now, Phlow is making medicines of urgent need due to the current COVID-19 pandemic. Many of these medicines are necessary for getting patients off ventilators, or critical care medications, key antibiotics or other drugs. While we can’t go into the specific drugs, because literally it is being treated as a matter of national public health security, as the U.S. continues to confront the COVID-19 pandemic and any future public health threat, Phlow is working to assure an uninterrupted supply of wholly domestic-made, life-saving medicines.
RM: Phlow’s name is derived from flow chemistry. How does flow chemistry compare with traditional batch manufacturing, how does it work? How can Phlow compete with overseas manufacturers and make the medications here?
Edwards: We really are pioneering the use of continuous manufacturing processes; continuous processing is an alternative manufacturing method that involves the use of flow reactors. What these flow reactors do is they allow chemical reactions to run on a much smaller scale, over and over again, until an entire volume of an active pharmaceutical ingredient is produced. That increases product quality and reproducibility and importantly has significantly lower labor requirements [as it’s highly automated].
Batch manufacturing has been used for these various essential medicines for decades. That involves one chemical reaction at a time, stopping and starting, and then having to assess the quality at the end versus being able to see that quality throughout the manufacturing process and adjust parameters [as needed on the fly] so you don’t have to throw out as many batches. You can assure that quality is being maintained.
RM: It looks like an intricate interlay of connections between Phlow, Civica, the Medicines for All Institute and AMPAC Fine Chemicals. How does that work, and what will that mean for the future?
Edwards: Phlow is a trail-blazing essential medicine impact company that is reimagining the essential medicines from start, utilizing flow chemistry, to finish, by reimagining the way we get these medicines into the hands of our customers. Medicines for All Institute, they’re really acting as the R&D partner for us, leveraging their innovative flow chemistry experience and their proprietary process manufacturing technology, to transfer that method over to Phlow, where we are bridging the gap until we have our own infrastructure with partners like AMPAC Fine Chemicals.
AMPAC Fine Chemicals is a domestic manufacturer of active pharmaceuticals and precursor chemical ingredients. They have a large facility in Petersburg. Phlow will work with them, as well as other approved manufacturers, to secure capacity for immediate production while we build our own manufacturing capabilities adjacent to AMPAC.
Then you have to get it into that finished dosage form, and we’re starting by focusing on sterile injectable drugs. The reason we’re focusing on sterile injectable drugs initially is because the majority of drug shortages in America are sterile injectables.
Our partners in Civica will then be building their North American manufacturing headquarters adjacent to our facility, really creating this unique industrial campus dedicated to manufacture essential medicines.
A rendering of the future Civica manufacturing facility (Image courtesy Civica)
RM: Why Petersburg? Was it just serendipitous?
Edwards: It’s all about relationships, right? [Phlow co-founder and CEO of the Medicines for All Institute] Dr. Frank Gupton ran process development at Boehringer Ingelheim [the German pharmaceutical company that operated at the site until 2014], before AMPAC took it over. This is a guy who comes up to the security gate and gives a big hug to the security guard who has been working there for years. He knows a lot of the people, knew a lot of the relationships.
RM: How should we envision the national stockpile of essential medicines?
Edwards: Right now, there is a strategic national stockpile of medical supplies and finished drugs managed by the Department of Health and Human Services. We have through this contract developed a unique public-private partnership with the federal government to stand up a new type of stockpile, and that is called the Strategic Active Pharmaceutical Ingredient Reserve. This reserve is a first of its kind reserve of the most critical active pharmaceutical ingredients and critical chemical input that are needed for these essential medicines.
[The reserve can be drawn from] when we see times of increased demand. That can be due to a trade dispute; it could be due to a natural disaster that takes out a plant [necessary to synthesize] a specific drug; it could be due to the next public health threat such as another pandemic. Phlow believes in a global supply chain; however, we also think that the United States should have access to the most important and critical ingredients for the medicines that are needed to sustain lives.
It’s safer, much like the strategic petroleum reserve in this country. It will house the precursor form of drugs that then can be converted to final drug form. It saves cost, the shelf life of the active ingredients is much longer than the finished dosage form, and it really ensures that we have domestic supplies in place.
RM: Any other plants in the works?
Edwards: We are in discussions with several partners and world-class organizations who see the great work that Phlow has begun, and understand that we are a public benefit corporation, pursuing that triple bottom line of financial, social and environmental return. Because our focus has been on significant impact, and it’s part of our governance and part of our culture, we have a lot of organizations who want to be part of this movement. Our plan is to be engaging with key and critical partnerships that allow us to leverage this federal contract and allow us to reach its fullest potential based on the infrastructure that we are building, and we’re working with the commonwealth of Virginia as well as the federal government on expanding our capacity and capabilities as we enter into these partnership agreements. There is much more to come based on what we’ve got started just in the last 12 months.
RM: There’s a new administration in place in Washington. Is there any change anticipated in what you all do, or in the funding for your work?
Edwards: One of the very few bipartisan areas on Capitol Hill right now is the desire for domestic infrastructure and bringing back American jobs and supply chain resilience. Phlow has garnered significant bipartisan support since we initially launched this contract. We had support from the entire Virginia delegation. We are working very closely with the new administration.
RM: How will Phlow’s work affect the average consumer? What does what you do mean for someone living in metro Richmond?
Edwards: For the native Richmonder, there’s nothing more meaningful than to know that we’re building up an infrastructure that’s going to have an impact on the lives of millions for decades to come, and we’re doing it all right here.
Also, it’s allowing us to become an advanced manufacturing hub, it allows us to attract highly technical jobs and is really [beneficial] to the workforce, for bringing over 350 jobs here to the central Virginia region, and Petersburg, which is in an economic opportunity zone. It means not only high-paying jobs and highly technical jobs, but also a workforce development program where we will be partnering with leading universities to ensure that we have that workforce for the future and advanced manufacturing.
And it means pride, that we have the country’s first public benefit pharmaceutical manufacturing organization that is dedicated to impact and making sure that when anyone in Richmond calls 911 to have an ambulance come for a family emergency, you don’t have to worry about whether a critical drug is going to be available.
