Category: Automation and High-Throughput Technologies

1068-D - Less than 1% Variation for Semi-Automated Filling into Cryogenic Storage Vials

Tuesday, February 6, 2018
5:00 PM - 6:00 PM

With the revolution of new biologic medicines, the need for a scalable, aseptic, and precise method to dispense into cryogenic vials when moving into commercialization is of vital importance. Cook Regentec developed a closed semi-automated system to address this need. Additionally, the system was designed: to provide high throughput with filling rates of up to 600 tubes per hour; for ease of use with simple exchange for sets of cryogenic storage vials; and for elimination of cross-contamination concerns with disposable transfer tubing. The semi-automated system is widely adjustable, allowing users to tune the setting specific for their media. A variety of tests have been performed to benchmark the capabilities of this semi-automated cryogenic storage vial filling system. One specific test involved the accuracy assessment of this system. This was performed using two representative fluids (normal saline and Cryostor® CS-10) to demonstrate consistent performance at difference viscosities. The test was also conducted targeting a 0.8 mL fill in a 2 mL vial and a 5 mL fill in a 5 mL vial. Testing was performed on a statistically valid sample size from a representative batch size. Filling accuracy was determined by measuring weights of vials before and after fluid dispensing. Results indicate a high level of accuracy within sample groups. The coefficient of variation was less than 1% (saline 0.8 mL CV=0.87%; Cryostor 0.8 mL CV=0.13%; saline 5.0 mL CV=0.11%; and Cryostor 5.0 mL CV=0.02%). In conclusion, we have developed a high throughput semi-automated cryogenic storage vial filling system that achieved a high level of accuracy within a closed-system across multiple vial sizes, filling volumes, and fill fluids.

Chad Johnson

Senior Research Scientist
Cook Regentec
Indianapolis, IN

Chad joined Cook Biotech Incorporated as a research engineer in December 2003. As a member of the Research Department, he was in charge of biomaterial assessment and improvement efforts. In 2007, Chad was promoted to research manager and led a team in the discovery, identification and feasibility testing of new biomaterials along with responsibilities for biocompatibility testing, scientific presentations to doctors, and authoring information for regulatory submissions. In September 2015, Chad transitioned to Cook Regentec as a senior research
scientist where, as part of a larger team of engineers and scientists, he is focused on development and commercialization of device-based regenerative medicine therapies.