Germfree Laboratories, On Demand Pharmaceuticals (ODP), and North Mississippi Medical Center-Tupelo (NMMC) have teamed up to address the global drug shortage crisis with a point-of-care medicine production solution.
The partners are now working to expand a pilot programme after a successful six months at North Mississippi Medical Center.
The collaboration combines Germfree’s mobile cleanroom technology with ODP’s Pharmacy on Demand platform, allowing healthcare providers to produce medications on site in appropriate environment conditions.
This local production reduces reliance on fragile global supply chains.
More than 75% of US hospitals face medication shortages
The expanding partnership aims to bring agile production of essential medicines closer to the point of care across the country and globally, ensuring a reliable supply of life-saving drugs.
With more than 75% of US hospitals facing medication shortages and millions of people in low- and middle-income countries lacking access to critical medicines, the need for localised, flexible production is urgent.
The journey of the collaboration
The partnership builds on a six-month pilot study that leveraged ODP’s platform technology and Germfree’s mobile cleanroom capability to produce syringes of common shortage medicines at NMMC, including lidocaine, rocuronium, and potassium chloride.
This real-world pilot met all regulatory requirements, leveraged a state-of-the art quality management approach, and demonstrated a novel, agile compounding capability for drugs on shortage.
“We’re not just filling gaps in the supply chain, we’re redefining it,” said Kevin Kyle, CEO of Germfree. “With On Demand Pharma, we are enabling healthcare providers to meet patient needs faster and more reliably, whether in urban centres or rural areas.
Kyle spoke to Cleanroom Technology back in September about this concept of decentralised manufacturing, and the role productised cleanrooms have to play in this future model.
We’re not just filling gaps in the supply chain, we’re redefining it
Matt Pietras, CEO of On Demand Pharmaceuticals, added: “This collaboration with Germfree provides us with the high-quality modular infrastructure needed to provide our Medication-as-a-Service (MaaS) where patients and healthcare providers need it most.”
Wes Pitts, System Director of Pharmacy at North Mississippi Health Services, was enthusiastic about the collaboration. He explained that the pilot programme compounded approximately 12,000 doses of shortage medications starting in December 2023 following regulations from the Board of Pharmacy.
Germfree acquisition of Arcoplast
Germfree has also recently acquired cleanroom wall expert Arcoplast.
Arcoplast is a manufacturer of leading seamless primary barrier cleanroom wall and ceiling systems for life science applications and more.
The acquisition will allow Germfree to offer comprehensive facility solutions from the ground up and follows 17 years of collaboration between the companies, during which Arcoplast has supplied architectural systems for Germfree installations at over 200 facilities globally.
Arcoplast primary barrier systems form the basis of design for BSL-3, ABSL-3, BSL-4, high-tech laboratories, and cleanrooms from NIH to CDC to NASA, throughout academia and in industries ranging from cell and gene therapy to food and beverage.
The Arcoplast system is differentiated from others through its numerous certifications around environmental sustainability while also being by far the most durable architectural finish available to life science clients, eliminating the need for maintenance. As well, the non-porous, ultra-smooth surface finishes, seamless panels, and high-performance Bio-Seal systems combine to enable best-in-class cleaning, disinfecting, and bio-decontamination that is backed up by science and testing.