UMass Lowell has opened a lyophilization testing facility where researchers and biopharma can develop freeze-drying processes in a non GMP environment.
The facility – dubbed LyoBay – is located in the Mark and Elisia Saab Emerging Technologies and Innovation Center at UMass Lowell, which is located northwest of Boston.
It is intended as a development space for scientists and biopharmaceutical companies according to executive director, Karen Hamlin.
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“The LyoBay offers users the opportunity to take their product technology from the laboratory scale to a highly optimized, non-GMP pilot scale utilizing state-of-the-art lyophilization equipment and technology.â€
The facility houses a pilot scale freeze dryer (FD) possessing a 1.9 m2 shelf area and a clean-in-place (CIP) system, housed within an ISO 5, low-particle count class 100 clean room Hamlin told us.
“The lyophilizer and CIP system were manufactured by SP Scientific. The freeze dryer is outfitted with a full complement of leading-edge process control systems and process analytical technology (PAT) tools to support process and analytical monitoring, preclinical process development and scale-up as well as training.â€
Non-GMP capacity
The idea is that biopharmaceutical companies pay to use the facility according to Hamlin, who told Bioprocess Insider there is lack of capacity in the US for early phase freeze-drying research.
“Nationwide, there are very limited resources that can serve as a testbed for pilot-scale, lyophilization process development and training under non-GMP conditions†she said, adding: “Most contract research organizations or contract manufacturing organizations are GMP certified and require work be done under GMP conditions.â€
While the facility will be available to large biopharmaceutical companies – many of which have operations in the Boston area – Hamlin expects LyoBay will be of particular interest to small and mid-sized biopharma.
“Although some of the large pharmaceutical companies have in-house capabilities, many are interested in UMass Lowell’s LyoBay for validation and training opportunities.
“For small to mid-sized biopharma companies, access to a non-GMP, pilot-scale facility allows further testing and product development prior to incurring the higher costs associated with the GMP-level requirements at a contract development organization†she said.