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Single-Use Technology for Cell Therapy

A New Standard of Medicine

Cell therapies have defined a new standard of medicine and are enhancing the treatment and prevention of diseases. Cell therapy (sometimes called cellular therapy or cytotherapy) uses intact cells, from either a patient (analogous) or an outside source (allogeneic), to fight disease and relieve medical conditions, such as nervous system, blood cancers, heart failure, diabetes, ailments of bones and joints, genetic disorders, injuries of the skin and soft tissues, plus many more. With the potential to cure chronic and rare diseases, the cell therapy industry is rapidly expanding.

Exciting Times for the Cell Therapy Industry

There are close to 900 companies worldwide and over 8,000 active clinical trials, or trials in the recruiting phase, working on all types of cures in cell and gene therapies, gene modified therapies and tissue engineering. Recent cell-based therapy approvals from the FDA and EMA are giving more and more patients long awaited treatment. With faster, more streamlined approvals and quicker development to market, the production of these therapies requires the design and implementation of efficient, cost-effective and sterility-assured processes to meet the growing demand.

Single-Use Technologies (SUTs) Benefit Cell Therapy Production

Historically, cell therapies are produced for small patient populations in clinical trials using laboratory scale equipment and using manual, open processes completed under a laminar hood. This method often is time consuming, expensive and prone to contamination. As more cell therapy products enter clinical trials and commercial production, developers and manufacturers are adopting and implementing single-use, closed system design for manufacturing efficiency and process flexibility to help lower costs, reduce time to market and maintain sterility.

Cross Contamination Risk Mitigation with SUT

Reducing the risk of contamination is crucial in manufacturing where the patient’s own cells are used for the treatment of a disease. Losing a dose to contamination or mishandling could mean the loss of the therapy itself. For the patients using these innovative treatments as a last resort losing or mishandling a dose could also mean the loss of a life. Using a SUT closed system offers the risk mitigation essential in manufacturing these complex and sensitive personalized therapies.

Make the Right Connection with CPC Aseptic Connectors

Standardizing on easy-to-use CPC aseptic connectors helps reduce system complexity and production costs by offering greater process flexibility and reliability. By easing the integration of SUT plug-and play assemblies, CPC aseptic connectors eliminate the convoluted process for connecting tubes via tube welding, where a cart and all the necessary components must be brought into the production suite and moved to the biosafety cabinet to be put together. With CPC single-use sterile connectors, cell therapy manufacturers no longer experience the costs and delays associated with the extra time needed for open manual processes. 

Secure and Sterile CPC Aseptic Connectors for Cell Therapy

The labor-intensive and open nature of cell therapy manufacturing make it highly susceptible to operator error and contamination risks. CPC aseptic connectors attached to the SUT ensure robust terminally sterilized closed system process continuously and each drop is secure and sterile from the patient to the patient. 

CPC Bringing It All Together for Cell Therapy Companies and Suppliers

Working with cell therapy manufacturers and partnering with equipment suppliers, CPC helps provide these lifesaving therapies by ensuring efficacious, repeatable and standardized processes are maintained. These companies recognize that one of the critical components in a single-use process for cell therapy manufacturing is the right connection technology. CPC's connection technology allows the aseptic connection of single-use to non-single-use steps in the process while maintaining a fully closed system. Matter of fact, cell therapy developers and process engineers find that collaborating with the experts at CPC helps with scalability, reproducibility and security necessary for their upstream and downstream production processes.

Meeting Cell Therapy Expectations with CPC Aseptic Connectors

  • Broad chemical compatibility
  • Performance integrity down to -80°C
  • Sterilization by gamma or autoclaving methods
  • Reliable, repeatable performance
  • Validation reports available
  • Minimal operator training to use connector
  • Wide portfolio of products from benchtop to cGMP production

CPC Aseptic Connectors: Decades of Experience, Forefront of Innovation

CPC has been delivering aseptic connectors to the biopharmaceutical market for decades. With this extensive biopharma experience, CPC engineers have applied their single-use technology for cell therapy to aseptic connector innovation. Laser sharp focus directly led to CPC’s development of AseptiQuik®, Steam-Thru® and MicroCNX® Aseptic Connectors, exclusively designed and built for the complexities of sterile upstream and downstream applications used in cell therapy manufacturing. CPC offers an advantage by providing guidance in critical areas, such as best practices in closed system design, that can be the key to cell therapy production success.

CPC Aseptic Connectors Benefits

  • Remove cumbersome steps in production
  • Minimize costs by closing operations that normally are performed under the hood
  • Save time and labor during set up, in production and in between batches
  • Eliminate cross contamination in between batches
  • Reduce the footprint of your processing area

Read More About the Latest Innovations and Technologies from CPC's Experts

Effectively Securing Cell and Gene Therapies with Closed Systems

The implementation of closed systems using single-use technology has helped to deliver life-saving therapies efficiently and economically.

Benefit of Using Single-Use Connectors Over Tube Welding

A survey of bioprocessing industry professionals asked which method they prefer for their connection needs: sealable and weldable tubing or aseptic connectors.

Cell and Gene Therapies: A Guide to Single-Use Connections - 10 Transferable Lessons from the Bioprocessing Industry

Industry experts expect SUTs used in biopharma clinical trials and commercial production to play a role in the development and production of cell and gene therapies.

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