By Eric Hennessy, Director of Product Development, Charter Medical
Cryopreservation is an indispensable part of bioprocessing and the manufacture of advanced cell and gene therapies. However, the success of cryopreservation heavily depends on the construction of single-use bags and components used to bring these life-saving therapies to patients. Biopharma manufacturers need these single-use solutions built to applicable specifications so they can withstand the harsh conditions of low- and ultra-low temperatures.
To better understand the freeze/thaw process when producing a clinical or commercialized therapy, biopharma manufacturers can engage in freezing studies. These studies can evaluate the critical aspects of cryopreservation, including the impact of temperature fluctuations on a therapy, how specific freezing times and conditions can impact single-use durability, and various handling and transportation scenarios. Therapy manufacturers can ensure that biopharmaceutical products maintain their integrity, functionality, and therapeutic potential by partnering with a trusted single-use supplier with design and testing capabilities.
Let’s examine why cryopreservation studies are so critical and how biopharma manufacturers can find a single-use supplier to help navigate the complexities of this critical process.
4 Common Types of Cryogenic Studies
There are four common types of cryogenic studies that can help biopharma companies better understand how their therapies will perform at ultra-low-temperatures:
1. Controlled-rate
Controlled-rate freezing studies focus on stressing single-use materials used in cryopreservation. The goal is to ensure single-use cryopreservation bags maintain functionality throughout the required freezing profile, ensuring they maintain integrity across various freezing points and brittleness temperatures. Reducing the ambient conditions in these studies from room temperature down to extreme temperatures ranging from -80°C to -196°C will assist biopharma manufacturers with understanding how the cell-based contents of the bags, as well as the materials used to construct the bags, react to the freezing and thawing process.
2. Long-Term
Long-term freezing studies are essential for assessing the viability and stability of biopharmaceutical products over extended periods of time in cryogenic storage. These studies help understand how different biological samples respond to prolonged freezing conditions, ensuring that their integrity, functionality, and therapeutic efficacy remain unaffected upon thawing. Conducting these studies allows manufacturers to confidently predict product shelf life and optimize storage protocols.
3. Therapy Containment/Protection
Bag protection studies assess how single-use cryopreservation bags interact with different types of containers and storage cassettes to keep therapies safe when handled before, during, and after cryopreservation steps. Validating these protective packages enables manufacturers to safeguard the quality of their products during the freeze/thaw steps.
4. Transportation
Transportation studies are designed to evaluate the resilience of single-use assemblies during different shipping variables, especially when using dewars with liquid nitrogen. Studies can include simulations of various transportation scenarios and testing that follow ASTM standards to precisely gauge the effects of different shipping variables. Transportation studies ensure therapies can remain stable and viable upon arrival to their final destination.
What To Look for in a Single-Use Supplier
Fortunately, biopharmaceutical companies don’t have to conduct these tests themselves — at least, not when they have a trusted single-use supplier they can partner with to perform them. Here’s what to consider when choosing a partner who can perform freezing studies for single-use cryopreservation solutions:
Single-use Design Optimization and Validation
Your single-use solutions provider should make sure that every component — from bags to tubing — is specifically engineered to withstand the rigors of cryogenic temperatures and maintain the biological integrity of the cell-based materials stored within. It’s about customizing solutions to fit the unique requirements of each biopharmaceutical application, ensuring that products not only meet current industry standards but also anticipate future needs, thereby streamlining the path from development to delivery.
Component Selection and Validation
Each single-use component, whether a tube, component, or container, must be thoroughly tested to ensure that it can withstand cryogenic conditions and is also compatible with the biological materials that it will come into contact with. A careful material selection and validation process fosters the safety, efficacy, and regulatory compliance of cryopreserved therapy products, enabling them to perform as intended throughout their lifecycle, from storage and transportation to administration to patients.
Material Development, Performance, and Analysis
The ideal single-use supplier should be innovating in the field of material science or enhancing existing materials to better perform under extreme cryogenic conditions. This involves analyzing the performance of materials in terms of durability and biocompatibility, and their ability to maintain integrity at ultra-low temperatures. It also requires extensive industry knowledge about which materials are safe and ideal for each application. Through extensive testing and analysis, single-use suppliers can assist biopharmaceutical manufacturers with optimizing single-use materials for cryopreservation applications based on their unique requirements.
Fostering Innovation and Collaboration in Biopharma Manufacturing
Charter Medical offers tailored single-use solutions for cryopreservation applications for bioprocessing, blood management, and cell and gene therapy to help biopharmaceutical manufacturers meet their unique needs for developing advanced, life-saving therapies for patients.
With a deep commitment to quality, Charter Medical leverages materials selection and design and development capabilities to create studies that help you navigate the complexities of cryopreservation. Our proactive approach to identifying and addressing potential risks early means you can build your biopharma manufacturing processes with confidence.
To learn more about Charter Medical’s freezing studies, visit https://chartermedical.com/cryopreservation/single-use-freezing-studies/. To learn more about our cryopreservation single-use solutions and services, visit https://chartermedical.com/cryopreservation.
About the Author
Eric Hennessy is the Director of Product Development at Charter Medical in Winston-Salem, North Carolina. He manages Charter’s Research and Development work as well as freezing studies and other activities at Charter’s Innovation Hub, also located in Winston-Salem. Eric has more than 20 years of experience in the medical device and biopharma spaces from working in R&D, manufacturing engineering, logistics, business operations, contract development, and manufacturing. Eric has a B.E. from Vanderbilt University and an M.S. from Clemson University.
About Charter Medical, LLC
Charter Medical, LLC has more than 30 years’ experience developing and providing specialty single-use products for bioprocessing, advanced therapies, and blood management applications, delivering solutions to the biotechnology and pharmaceutical markets.
Our 16,000 square feet of cleanroom space located in Winston-Salem, NC, is ISO 13485:2016 certified and FDA registered, with a focus on designing and supplying single-use solutions for cell growth, frozen storage, and biological fluid handling. Custom product design services are available for clients who need specialized single-use products for biomanufacturing. Our team of engineers will work with you to develop the best solution for your specific requirements.
Charter Medical is committed to providing quality products and services with an experienced staff dedicated to exceeding customer expectations, from product development to delivery and implementation.
At Charter Medical, we work closely with our sister companies, Polyzen, SanaVita Medical, and Secant Group, to provide essential products and services to life science companies. Through integrated research and development activities, we are helping to bring new technologies and therapies to market.