RoSS.FILL CGT is a fully automated aseptic cell and gene therapy filling system. A filling machine that allows multiple small single use bags to be filled simultaneously. This CGT bag filling system is special designed for use in cell & gene therapies with batch sizes at low volumes.
With its high filling accuracy, the platform provides filling for up to 36 bags with one rack - having the option to attach more racks.
Read more about the features and benefits of our cell and gene therapy bag filling system:
Modular filling enabling process flexibility for viral vector manufacturing for many bags of small volumes. Aliquoting up to 126 single-use bioprocess containers with 3mL to 100mL each, this revolutionary system sets a new standard for precision and reliability.
3 functions in 1 device: Fast filling with variable fluid control and simple aseptic decoupling
Good Manufacturing Practice (GMP) summarizes regulations for ensuring that products are consistently produced and controlled according to quality standards. Nevertheless, product quality and safety are to be granted all along the manufacturing process of biopharmaceuticals.
Frequently, one can also come across the abbreviation cGMP – the “c” refers to “current”, underlining that industry standards undergo constant improvements that manufacturers need to adapt to.
Since RoSS.FILL CGT is compliant to these standards, the aseptic filling system is ready to be integrated in your cGMP compliant cell and gene therapy manufacturing processes.
What is important in Cell and Gene Therapy filling? Bioinsights published an interview with Barbara Fischer, Process Consultant at Single Use Support. It is about challenges and solutions in the field of automated aseptic filling for lowest volumes in CGT. Read the full interview now.
A cell therapy filling system consists of highly specialized devices and containers that are designed to provide filling of cell therapy products into bioprocess containers. This filling process is to be carried out without contamination of the processed goods, which is why cell therapy filling systems create an aseptic environment in which the fluid transfer is performed.
Within gene therapy, three different types can be distinguished:
Before cell therapy products can be applied, they need to undergo a delicate manufacturing process, which also includes aseptic filling and draining. These processes have to ensure maximum product quality and safety and avoid the risk of contamination.
Gene therapy – genetic material is put into place to modify a person’s cells. This is the case, for instance, when viral vectors are used to insert DNA segments into cells.
Cell therapy – entire cells are inserted into a patient for therapeutic purposes. For instance, stem cell therapy can be applied when facing certain medical conditions.
One example of cell therapy is stem cell therapy: Harvested cells – either from the patient him-/herself or from a donor – can be given to a patient in the course of the treatment of medical conditions like various types of cancer.
Cell therapy products can be part of the treatment of a great variety of medical conditions and diseases. They can come either from the patient’s body – in the case of autologous cell therapy – or derive from a donor, in which case one would speak of allogeneic cell therapy.
In general, two different types of gene therapy can be distinguished:
In vivo gene therapy involves genetic material to be inserted into a patient’s cells while they are still in his or her body, usually by the means of a vector, for instance AAVs.
Ex vivo gene therapy, on the other hand, demands for certain cells to be extracted from a patient’s body to then genetically modify them before reinsertion.
Although the manufacturing of cell and gene therapies is highly individual, there are certain mutual steps along their supply chain.
Cell and gene products need to be kept viable ex vivo and simultaneously be prevented from quality and safety loss as well as contamination. This applies to the filling and draining process, but also to safely freezing and thawing of the biologics.
It is vital to avoid quality and safety loss as well as contamination, which is to be achieved by aseptic filling processes. Furthermore, storage temperatures must meet the products’ individual needs – be it cold, ultra-cold or cryogenic storage. To achieve the required temperature stability, high-performance freezers are required, and also the thawing process is to be carried out with enormous delicacy and accuracy to make sure that the cell or gene therapy product comes with the required quality and safety.
Single Use Support provides dedicated end-to-end solutions for a safe, efficient and scalable manufacturing process of cell and gene therapies, including fluid management systems, a freeze/thaw platform, a fill/drain platform and a variety of single-use bioprocess containers.
