XstalBio: New Tech Offers Speedier Biologic Reconstitution
For reconstituting biologic drugs such as monoclonal antibodies from a freeze-dried powder state, “manual swirling has been used as the method of choice for decades,” Dr. Barry Moore, Chief Scientific Officer at XstaBio, told Biopharma-Reporter.com.
This “would typically take at least 30-40 minutes of manual swirling to make a 200 mg/ml solution,”he continued, and“is likely to have some foam on top of it which may reduce the volume that can be injected.”
The company’s alternative technology, CentuRecon, works by firstly adding a diluent to the powdered biologic in a vial as per industry norm, Moore explained, and then applying a centrifugal force“to remove adsorbed air bubbles from the suspended powder allowing the diluent to wet the solid and resulting in much faster dissolution.”
“With CentuRecon less than 10 minutes in the centrifuge will typically produce a crystal clear solution with no foam,” he told us. “The absence of foam gives greater confidence that there is no aggregated protein present and that the solution will be safe to administer.”
According to Moore, market alternatives to manual mixing are limited, with the use of a mechanical swirling device neither substantially speeding up the reconstitution process nor producing less foam.
Furthermore, the company says CentuRecon can work for very high concentration and viscous solutions in normal vials, cartridges and dual-chamber syringes.
R&D and Licensing
The firm is looking to license the technology but Moore said for now XstalBio hopes “to get R&D scientists to test CentuRecon out in their labs.”
“It can be used to reproducibly reconstitute multiple samples at the same time and so will save a lot of valuable research time,” he said. “Once the R&D scientists are convinced we would expect to see clients approaching us to take out licences and to start to think about clinical applications.”
