Cell Storage Solutions for Cellular Manufacturing of Clinical Products
Cell and gene therapies have become increasingly popular in the last few decades, especially with the recent FDA approval of CAR T-cell therapies such as Kymriah and Yescarta. These life-changing therapies are the latest in scientific and technological advancements in the field of regenerative medicine and it is exciting to see the progress that has been made in just the last few years.
The success of cell and gene therapies doesn’t just rely on the effectiveness of the final products themselves, it also relies heavily on the ability of manufacturers to overcome the logistical challenges associated with the manufacturing, processing and administration of these complex products.
The increase in demand for these therapeutic products has been accompanied by an increase in demand for processing solutions that will increase the efficiency of the manufacturing process in order to make these products available at a larger scale and at an affordable price.
Cellular Manufacturing for Cell and Gene Therapy
The manufacturing process in a conventional operation takes place in one manufacturing facility. Cellular manufacturing, however, extends beyond one location, creating unique logistical challenges. Cell manufacturing begins with the collection of cells from the patient, which takes place in a clinical facility, and ends with the administration of the drug into the patient (either the donor themselves or a recipient). In between collection and administration, there is a complex supply chain process, throughout which the integrity of the cell sample must be maintained.
Contract development and manufacturing organizations (CDMOs) can help alleviate these challenges, particularly if drugs are to be manufactured at a large scale. These are companies that provide drug development and drug manufacturing services in the pharmaceutical industry on a contract basis.
Cell and Gene Therapy Supply Chain Process
The cell and gene therapy process has many steps from process development to fill and finish. Cells are collected from the patient, then transferred to the manufacturing site for genetic modification and production. The therapy is then shipped back for administration. When the material is being shipped, it must be done under very specific conditions – freezing cells under liquid nitrogen – in a very short period of time. This transfer of therapy requires a strict temperature chain and monitoring to ensure its safety and effectiveness for patient administration.
How Automated Cell Processing Can Improve the Manufacturing Process
Manual cell processing is the more common approach for many cell banks, due to its cost effectiveness. However, automated cell processing with highly sophisticated technologies such as the X-SERIES Systems has benefits such as a lower risk of contamination, greater consistency in the process, and the peace of mind of being Good Manufacturing Practice (GMP) compliant.
Cell Storage Solutions
There are several options for cell storage during the cell manufacturing process. In order to be in compliance with Good Manufacturing Practices (GMP) Cell Manufacturing, cells must be cryopreserved (frozen) at a specific temperature. One of the original methods was with the use of cryogenic storage bags, which are compatible with liquid nitrogen for maximum cell viability. While this is a reliable method, it is also completed manually and is thus more time consuming and also more prone to risks associated with human error. The challenges presented by the supply chain process of cell manufacturing is creating a greater demand for technological solutions. It is imperative to reduce the risks and costs associated with cellular processing and cell storage.
The best way to reduce risks, maximize efficiency and reduce costs is to utilize automated cell banking options, such as the BioArchive® System.
How the BioArchive System Offers an Automated Solution for Cell Storage
Automated cell processing and storage offers many benefits, including greater accuracy and faster process optimization. Through the use of sensors that provide continuous online measurements, automated systems like the BioArchive® offer greater control over the supply chain process.
The BioArchive® System offers a solution for cell storage, tracking and retrieval with automation and certainty. Samples are stored at a consistent -196°C temperature which is controlled through a closed system with robotic storage and retrieval, minimizing sample exposure to transient warming events (TWE). This ensures the greatest integrity of cells and offers a 94 percent post-thaw cell viability.
This fully automated system offers a solution for every step of the cell storage process, providing scientists and medical professionals with the utmost confidence in the final products which are administered to patients.
ThermoGenesis and Automated Solutions for Cellular Manufacturing and Processing
The BioArchive® System is an innovative technological breakthrough which has been developed with the needs of laboratories and physicians in mind, providing the resources they need to ensure the highest-quality final products for their patients.
ThermoGenesis Holdings, Inc. is a pioneer and market leader in the development and commercialization of automated cell processing technologies for the cell and gene therapy fields. We market a full suite of solutions for automated clinical biobanking, point-of-care applications and large-scale cell processing and manufacturing with a special emphasis on the emerging CAR T immunotherapy market. We are committed to making the world a healthier place by creating innovative solutions for those in need.
For more information on our entire suite of automated solutions, please contact us.
