End-To-End Solutions for Cell & Gene Therapies

Small Volumes

Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells. More and more cell and gene therapies have been approved and are available globally. 

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Cell Therapy

Based on using human cells this type of regenerative medicine targets cancer cells and genetic diseases. Stem cells that are taken either by the patient or from a suitable donor are modified and (re-) injected intravenously into the patient. 

  • CAR-T cell therapy is one of the most prominent autologous patient-centric treatment for patients suffering from certain types of leukemia/lymphoma. Cold chain logistics including timely and secure transport of low volumes of treatment are key.  
  • With allogeneic treatments multiple patients receive the modified, grown, and harvested cell from a single donor for treatment, reaching higher volumes ultimately. Allogeneic cell therapy is therefore generally manufactured in batches and requires storage before delivery.

Gene Therapy

Under gene therapies fall in-vivo viral vector production, such as AAV or lentivirus, plasmid DNA production and ex-vivo gene modified cell therapy. The latter is in turn distinguished from autologous and allogeneic therapies. 

Blood cells are taken from a donor to be modified, grown, and harvested for the same donor (autologous) or multiple recipients (allogeneic). DNA is extracted to be genetically modified ex vivo. It is then re-infused in the patient’s system to target cancer cells.

Innovative CGT process solution

With the use of Single Use Support’s technology, biopharmaceutical companies in the area of Cell and Gene Therapy (CGT) and Regenerative Medicine can minimize the risk of bio contamination, manipulation or product loss towards 0%. Mostly small batches of either t-cells, buffer, primary cells or media are supplied and delivered between biopharmaceutical companies, biotech companies, CMOs, CDMOs, hospitals and other suppliers. 

Single-use technologies that perform fast operations accelerate time-critical process for cell & gene therapies. Integrated and scalable process solutions around single-use bioprocess containers that include automated aseptic filling and controlled freezing and thawing optimize and standardize logistic process steps for ATMPs.

Products

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ROSS.KSET | Protecting small single-use bags

RoSS.KSET offers the protection for drug substances with volumes less than 250 mL. The shell is robust, closed, safe and sterile – most suitable for cell and gene therapies or clinical studies.

For larger volumes, RoSS can protect one or multiple single-use bags in one shell.

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RoSS.FILL CGT | Automated filling platform for CGT

Fully automated platform system for aseptic filling of multiple small single use bags. 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.

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RoSS.pFTU Lab-Scale | Freeze-Thaw Platform

Compatible with single use bags of all sizes and manufacturers. Our lab scale freezer is the perfect solution for studies conducted in labs and, above all, if you want to start a controlled and scalable freezing process.

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RoSS.LN2F | Cryogenic Freezer

RoSS.LN2F is a powerful cryogenic controlled rate freezer for temperatures down to -180°C/ -292°F. An enclosed LN2 system and our innovative direct injection system ensure no direct exposure and no mechanical compressors are needed. This ensures a safe, low-maintenance and energy-saving handling.

Features and Benefits

  • Adaptability of single-use systems
  • Closed system through single-use bags reduces risk of contamination
  • Protection of bioprocess containers reduces product loss through breakages
  • Accelerated operations thanks to automation
  • Independent from size and manufacturer of primary packaging
  • All-in service
  • Scale-up thanks to modular technologies
  • Optional upgrade to Pharma 4.0 cloud-based data analysis

More information

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Cell and gene therapy: In vivo and Ex vivo in comparison

Gene therapy is a technique that modifies a person’s genes to treat or cure disease. Ex Vivo and In Vivo are two different approaches you will learn about in this article!

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Single-use end-to-end solutions - flexible, scalable and reliable

In an extremely complex, competitive and constantly evolving sector such as the biopharmaceutical industry, flexibility is key, not least since it is an immensely varied and compliance-driven field. Learn more in this article!

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Single Use Support investing 20 Mio EUR in end-to-end solutions for cell & gene therapies

Single Use Support invests 20 Mio. EUR in development and research of Biopharma novel process solutions in cell & gene therapies. The Austrian company’s next upcoming innovation will be the launch of its own single-use bags.

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End-to-end solutions for optimized drug substance logistics

You know about the risk of contamination due to human error with drug substances in the biopharma industry? In this article you will find out why Single Use Support is with its end-to-end solution your partner in the biopharmaceutical market.

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