~ Executive Director of AMPAC Fine Chemicals’ Petersburg, Va. facility discusses the company’s core competency, strength in the ‘Advanced Pharmaceutical Manufacturing’ process ~
By: Logan Barry
Both, the research & development and continuous processing technology for scale-up, “Advanced Pharmaceutical Manufacturing,” are already in place for the pharma cluster in Petersburg, Virginia. This is thanks to the Virginia Commonwealth University College of Engineering’s Medicines for All Institute, or “M4All” for short, and Phlow Corporation, respectively. An additional core strength that ensures that this pharma cluster ecosystem flourishes is the on-site development of “Active Pharmaceutical Ingredients,” known as APIs at AMPAC Fine Chemicals.
AMPAC Fine Chemicals — abbreviated AFC — is an industry leader and will lead the cluster’s API manufacturing arm before sending it literally around the block for the final, “Fill-and-Finish” stage. Fill-and-Finish will be handled by Civica Rx. The VCU College of Engineering and M4All, Phlow Corp., AFC and Civica make up the strategic partnership working with Virginia’s Gateway Region Economic Development Organization to advance this revolutionary pharmaceutical initiative to, once again, have medicines that are “Made in the U.S.A.,” in addition to fostering economic prosperity for the region.
AFC has a beautiful, 144-acre campus, which up until a few years ago, was not fully operational. In 2016, AFC began ramping up production from new contracts AFC secured which ultimately led to the current collaboration with Phlow and Civica. The AFC campus resides in the Gateway Region which is strategically located on the East Coast near multiple pharmaceutical companies in the Northeast U.S., Mid-Atlantic as well as North Carolina’s Research Triangle Park.
Workforce readiness, recruitment — are key in obtaining AFC’s goal for establishing AFC Virginia as the company’s East Coast production
Elso DiFranco, Executive Director and General Manager of AFC in Petersburg, says the goal is for AFC Virginia to be the production hub for APIs on the East Coast, not only to service its customers, but to help with the growth of the company.
DiFranco talks about what the company has done and is continuing to do to accelerate that growth.
“The Petersburg area is known for transportation, so it’s easy for us to get supplies and raw materials on site … And the Gateway Region is in close proximity to enough major cities where we can draw from the talent pool for whatever is needed,” DiFranco says, explaining that in order to run a pharmaceutical facility, process technicians are needed. “We call them ‘chemical operators’ — we’ve been able to bring a lot of people on board who previously worked at our plant as well as folks from other industries.”
He says that the workforce recruitment and development for these positions is the grassroots part of the job.
“To have the processes lined out where you’re ready for commercial manufacturing, you need a chemistry team to onboard the programs,” DiFranco explains. “They’re sort of the tip of the spear, so we’ve hired in that area as well.”
“The pivot point in all of this is our engineering staff — they take the program from the chemists and translate it into the batch record, which is used to run production. Everything else follows from this, including quality control and quality assurance. The quality control team supports a 24/7 operation — there’s shift work needed there too — and so we’ve beefed up that area,” he points out.
The people working in positions that make up the quality control, quality assurance, engineering and chemistry teams are highly skilled professionals with chemical production experience, chemistry training and advanced degrees; while the maintenance and operations teams are people with high school diplomas, associates degrees and skilled labor — the diversity in job opportunity is an advantage for workers in the Gateway Region.
“From December 2020 to February 2021, we went from a headcount in the low 60’s to around 110 — that’s unprecedented growth in that amount of time,” DiFranco emphasizes, saying that the majority of new hires were in production and maintenance. As AFC continues to bring more of the facility’s equipment online, he says they’ll require additional production, maintenance, chemistry, quality and engineering staff to support logistics, warehousing and purchasing.
About VGR’s Advanced Pharma Campaign:
Virginia’s Gateway Region is well on its way to becoming a transformational Advanced Pharmaceutical Manufacturing cluster. Living in a post-COVID-19 world has shown 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 for years to come. To learn more, visit VGR’s campaign landing page, at: www.GatewayRegion.com/Rx.
About AFC
AMPAC Fine Chemicals — an SK pharmteco company — is a U.S.-based, custom manufacturer of active pharmaceutical ingredients, known as APIs, and registered intermediates. AFC solves problems through technology and innovation to reliably deliver quality products that save and improve lives.
About Elso DiFranco
Mr. DiFranco has a PhD in Chemistry and over 25 years of experience in the pharma industry. He is an Executive Director and General Manager at AMPAC Fine Chemicals Virginia, with responsibility for operations at the site.
