AT-Closed Vial® and Container Closure Integrity during Cryogenic Storage
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Together on a journey of making cell and gene therapy a commodity
Challenges
Cell and gene therapies are transforming the modern healthcare paradigm, giving hope to patients suffering from a variety of diseases from ophthalmology to oncology.
The manufacturing of these products, personalized (autologous) or off-the-shelf (allogeneic), is currently associated with high cost of goods. The fill & finish, as one of the last steps in the manufacturing process, is identified as critical and strategic in order to timely deliver the treatment to the patients. Moreover, to preserve their quality attributes, the cell therapy, gene therapy and elements of their production, are most often cryopreserved. This fact imposes particular requirements on the logistics, the primary container and the overall fill and finish process.
To avoid important bottlenecks at later phases, the appropriate choice of GMP-compliant technology shall be done as early as possible.
Widely Used for
Autologous therapies
“One patient - one batch” logic requires a robust small scale filling process, reproducible for hundreds and thousands individualized productions.
Small scale fill & finish is manual and operator dependent, that is usually associated with complex SOPs, higher contamination risks and human errors due to the rapidity of operation in a short window from the moment of the product mixing with the cryoprotective agent to the finished product freezing.
Discover our manual filling solutions based on the closed vial filling process, securing the success rate of manufacturing process and product delivery to the patient, waiting for his personalized treatment.
Allogeneic therapies
Allogeneic platform significantly accelerates the patient access to the therapy, since it can be standardized and manufactured for off-the-shelf availability. Such manufacturing logic brings these therapies close to the more common biotech field, allowing efficient scalability, with introduction of automation. The logistics and infrastructure burden of cryopreservation still remain, since the products are stored in vapor phase of liquid nitrogen.
Discover how our manual, robotized and high-speed fill & finish machines provide the gradual scaling-up, supporting cell and gene therapy companies and their CDMOs globally.
In-vivo gene therapies and vectors
One of the important challenges of the cell and gene therapy field today is the viral vector capacity and yield. That makes the product loss for such complex ingredients unacceptable.
The manufacturing capacities of the Plasmid DNA are still limited too, motivating numerous companies to bring the production in-house, in order to secure the timelines of their transition to GMP and further development. In-vivo gene therapies and vectors are typically stored at -60°C-80°C in single doses as low as 100 microliters.
Discover how our filling process can be brought in-house in just 4 weeks, providing accurate filling of small volumes and ensuring safe storage of deeply frozen products.
GMP cell banks
The GMP cell bank is the fundamental element for consistent biopharmaceutical production.
The master and working cell banks usually consist of several hundreds of vials that are stored in vapor phase of liquid nitrogen until use, to avoid genetic variation and potential contamination.
The choice of a safe container system ensuring long-term cryopreservation, avoiding risks of contamination and cross-contamination (e.g. with mycoplasma) is essential.
Learn how the AT-Closed Vial® and the associated filling process provides container closure integrity at ultra-low temperatures, ensuring safety of the GMP-compliant cell banks and contributing to the batch-to-batch consistency.
Inspiring cases studies
Our technologies bring consistency and robustness to the fill and finish processes of cell and gene therapy players globally
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