Aseptic cell filling system | RoSS.FILL CGT

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:

• gene augmentation therapy – when a new DNA segment is inserted into a cell, e.g. to substitute one that is not functioning.
• gene inhibition therapy – the genome is modified in order for a gene to be inhibited from being expressed.
• targeted cell killing – specific cells are genetically modified with the aim for them to be killed.

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.

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.

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.