Cell and gene therapies filling system - RoSS.FILL CGT

Automated aseptic filling for CGT | 10mL-1000mL

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.

Cell and gene therapy filling machine with RoSS.FILL CGT system
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Fujifilm Diosynth

Moderna

AGC Biologics

Features and Benefits of our CGT bag filling machine

Read more about the features and benefits of our cell and gene therapy bag filling system:

  • Used for dispensing biologics, such as viral vectors, cell cultures, cell therapies and gene therapies, into single-use bags. These can be protected by RoSS.KSET protective shells.
  • Contains 1 control unit and 1 rack with 3 weights standardized – extendable upon request – at small footprint
  • Filling of up to 36 single use bags ranging from 10mL to 1000mL
  • Usage for studies in labs, cell & gene therapies or seed train intensification.
  • Highest possible bag filling accuracy
  • Airless filling
  • Label printer included
  • GMP-compliant

Advanced Sealer & Stepper Pinch Valve

2 functions in 1 device: Variable fluid control for fast filling + simple aseptic decoupling

Automated Sealing Function:

  • Dropless disconnection by sealing
  • No need for cumbersome post processing of metal seals and giving the benefit of removing sharp edges
  • Fully aseptically closed – no risk of leakage
  • Simple Aseptic Decoupling: safer, automated disconnection
  • The fully tested sealed tubings withstand a temperature of up to -190°C


Automated Stepper Function:

  • Closed or open or anywhere in between
  • Run your pump at 100% speed - allow the stepper to control the fill rate
  • Unprecedented levels of control in your fill recipe
  • Fastest filling rate
  • Fill several bags in parallel*
RoSS.FILL_Sealer-Stepper Valve Rack_2
Sealer Valve_3

GMP compliant to fulfill high standards

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.

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FAQ about cell therapy filling system

What is a cell therapy filling system?

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.

What are the 3 types of gene therapy?

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.

What are the filling and draining processes involved in cell therapy?

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.

What is the difference between gene therapy and cell therapy?

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.

What is an example of cell therapy?

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.

What are cell therapy products?

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.

How does gene therapy work?

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.

What are the production process steps in cell and gene therapies?

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.