Singota Solutions recognized a gap in the market for contract aseptic filling services. They realized that companies developing new drug products and needing to fill batches of 20,000 units or less were underserved by contract manufacturing organizations (CMOs). CMOs wanted large ongoing projects, and clients lost control of their schedules when the CMOs couldn’t accommodate small runs.
With formulation development, labelling, and other adjacent services already being offered, Singota decided to add aseptic filling. As a result, whether their clients are Big Pharma or a small virtual company, Singota could offer filling at the development and clinical stages, as well as small-volume commercial products.
They sought out an aseptic filling technology that would enable them to provide an agile, high quality service. After a thorough vetting process, Singota decided on Vanrx’s SA25 Aseptic Filling Workcell.
“By choosing Vanrx, with one machine we could provide vial, syringe and cartridge filling services with the short lead times our clients wanted. On our operational side, we could switch quickly between different formats and make them all at equally high quality levels,” explains Brent Lieffers, Senior Director of Operations at Singota.
“Our filling team had experience with traditional filling lines, restricted access barrier systems and gloved isolators. We feel that Vanrx’s technology solves the challenges associated with these systems, since the SA25 has fast VPHP decontamination cycles and effectively removes operators from both the environment and the process. That’s the type of aseptic assurance our clients want. Also, it has a much smaller footprint than other flexible filling systems,” Lieffers says.
Singota’s goal has always been to get products to patients faster. The SA25’s design and technology combined with Singota’s agile, full-service offering make that possible. Singota now has an increasingly busy schedule of filling projects, including contracts with large multinational biopharma companies. Their first completed filling runs are scheduled for upcoming clinical trials. Coupled with their complementary services of formulation development and supply chain, the SA25 has proven to be a perfect fit for the niche, smaller batch aseptic filling business that is Singota’s specialty.