Freezing Studies: Data-Backed Decisions For Cryopreservation Solutions
Optimize single-use solutions for cryopreservation by engaging in studies that focus on specific timepoints and conditions pertaining to therapy storage, containment/protection, and transportation.
Confidently build your biopharma process with us
Designing freezing studies with a single-use supplier that engineers standard and custom cryopreservation solutions enables you to choose the appropriate single-use materials and minimize risk to ensure your biopharma manufacturing process meets your cold chain needs and the needs of patients.
Charter Medical offers the following studies with single-use solutions to assist you with material selection, performance, and analysis:
1. Controlled-rate freezing
Controlled-rate freezing studies evaluate the resilience of single-use assemblies. Our engineering team examines single-use material behaviors during temperature fluctuations in the freeze/thaw process, from room temperature down to -80°C or -196°C across various manufacturing conditions. Through precise freezing profiles and tailored test reports, we help you determine the integrity and viability of your therapy from start to finish.
2. Long-term freezing
Long-term freezing studies – from multi-month to multi-year investigations – focus on the importance of specific freezing times and conditions based on your cryopreservation processes requirements. Our studies can be designed to demonstrate the durability and effectiveness of our single-use solutions when it comes to maintaining the quality and viability of your therapy for extended durations.
3. Therapy containment/protection
Therapy containment/protection studies are designed to understand how our single-use cryopreservation solutions interact with different types of containers and storage cassettes. We perform drop-testing and engage in other approaches to identify ideal methods for safeguarding single-use bags and components to help you ensure therapies remain safe during transit.
4. Transportation
Transportation studies are designed to evaluate single-use assemblies during shipping, especially when using dewars with liquid nitrogen. Our studies include simulations of various transportation scenarios and ASTM vibration tests with adjustable settings to precisely gauge the effects of various shipping variables. We provide detailed test reports tailored to your process needs, empowering you with actionable data to optimize therapy protection during transit.