Cell and Gene Therapies

Secure connection each step of way can be proven from patient in the apheresis (leukopheresis) center to the cell processing /manufacturing site and back to the patient.

Connection can be used throughout the production from vector amplification and seed train; to the vector expansion in Bioreactors; then to clarification and purification; to polishing and finally to fill and finish filtration to be transferred into the final product vessel. Through out your production CPC connectors can ease your operation.

To ensure sterility the AseptiQuik can be gamma irradiated, high temperature versions of the product can be auto clave and gamma irradiated to reduce validation step from small clinical trial to large scale manufacturing.

Cell and viral vectors that are frozen and shipped can be stored in the freezer with the AseptiQuik already placed on the assembly. The AseptiQuik can withstand temperatures down to -80° Celsius. More details on freeze-thaw validations of the AseptiQuik.

While the CGT industry is still evolving and developing their own methods, bioprocessing guidelines can be transferred to CGT. CPC connectors are a respected solution provider in bioprocessing can transfer its proven product in the processing of cell and viruses for advanced therapies. Because of that, industry experts expect the single-use technologies (SUTs) with connectors used in biopharmaceutical clinical trials and commercial production to play a large role in the future development and production of CGTs.

SUTs are already used in the development of CGTs today. However, many of those SUTs cannot be transferred from laboratory scale into commercial manufacturing for a variety of reasons, including extractables, leachables, supply chain security, reproducibility, and scalability. These issues will need to be overcome, and solutions developed soon, to meet the pace of CGT development. As CGT manufacturing processes evolve to meet regulatory, economic, and patient safety, some learning will come from bioprocessing, while other learning will have to emerge that is specific to CGTs.

Get a high-level overview about how the use of SUTs in biopharmaceutical manufacturing that can be applied to CGTs, with a special focus on connection technologies.

CELL & GENE THERAPIES: A GUIDE TO SINGLE-USE CONNECTIONS -10 Transferable Lessons From The Bioprocessing Industry

Closed single-use systems like Aseptic Connectors with proven and validated technology can reduce the risk of biological contamination and cross-contamination which can be costly and affect patient and operator safety. Raw material in cell and gene therapy are the patient cells in most cases. A controlled closed system should always be maintained.

Effectively Securing Cell and Gene Therapies with closed systems

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Reduce the footprint of your lab and GMP process area by eliminating the hood. AseptiQuik can provide a sterile connection even in non-sterile environments, without the use of a Laminar hoods. Using SUT with aseptic connectors would drastically reduce the footprint of your production facility.

Using tube welding is very timely and the threat of extractables and leachables could impact their cells and effectiveness of the therapy. Particulates produced during tube welding may produce extrinsic particles that could possible produce risk to the product and process and ultimately patient. This is especially significant for low volume, where particle size and no filtration step can affect the process.

Download our white paper around the benefits of using single-use connectors over tube welding

Listen as our industry panel discusses challenges facing the development of cell and gene therapy technologies and shares their ideas for the future. Learn how to maintain the integrity of a drug substance and safeguard your downstream processes.

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