Gibco CTS DynaCellect Magnetic Separation System Features

An important advantage of the CTS DynaCellect system over current isolation and bead removal equipment is its processing speed. The cell isolation protocol can process up to a 1 L volume (10 billion target cells) in approximately 70–100 minutes, depending on the pump speed. The automated bead removal process uses a continuous flow to ensure rapid and efficient processing. Whether working with an autologous or allogeneic workflow, bead removal can be carried out at a processing speed of 50 mL/min with >91% target cell recovery rate when using Gibco CTS Dynabeads CD3/CD28. There is the potential to run up to 150 mL/min with the peristaltic pump.

Bead removal process time is significantly reduced with the CTS DynaCellect Magnetic Separation System

View more sample data ›

Translating cell therapy manufacturing from research to clinical and commercial scale can be challenging. The emergence of allogeneic cell therapies has meant longer workflows and larger outputs to create several doses. This trend will become more pronounced as the industry transitions from T-cell to NK-cell therapies and towards IPSC-derived cell therapies. From small autologous batches to larger allogeneic ones, the highly scalable CTS DynaCellect system helps ease this transition and avoid late-stage process modifications.

This highly scalable system is capable of processing reaction volumes from 10 mL to 1 L (with an optimal density of 100 million to 10 billion target cells) for cell isolation, accommodating scales for autologous and allogeneic therapies. Similarly, bead removal is highly scalable. Since a continuous flow process is used, the volume for bead removal is potentially unlimited. To date, we have tested up to 10 L. Whether working at small scale or large scale, the DynaCellect system consistently results in high cell viability, recovery, and a minimal number of residual beads.

Whether it’s used for isolation, bead removal, or both, this highly adaptable system and sterile, single-use kits offer flexibility from process development to clinical and commercial manufacturing. The CTS DynaCellect Magnetic Separation System comes with two protocols: cell isolation and bead removal. Choose either of these from the menu or create and optimize your own protocol. Whether you need to modify the magnet engagement, pinch valves, pump speed, rocker angles, or customize the software for optimal protocol design for different cell types, the CTS DynaCellect system can be adapted to meet your needs.

When you scale up to commercial manufacturing, we recommend switching into clinical manufacturing mode. This mode locks down your optimized protocols so that manufacturing settings cannot be altered.

Clinical manufacturing mode also includes an optional software module that supports electronic record-keeping in a way that is compliant with the US Food and Drug Administration’s Electronic Records and Signatures Rule, Part 11 of Title 21 of the Code of Federal Regulations (21 CFR Part 11). This rule defines the requirements for use of electronic documents in place of paper ones.

Capabilities of the software include restriction of unauthorized users, password policies and expiration dates, defined user permissions and roles, tracking of all data changes through an audit log, audit reports, and on-board e-Signature workflows. These are sometimes abbreviated as Security, Audit, and Electronic-signature capabilities, or SAE, and you can control them through the SAE Administrator Console.

To run your DynaCellect system in clinical manufacturing mode, you need a DynaCellect 21 CFR Software License. The license can be purchased, and a field service engineer will complete the installation at your site. Per 21 CFR Part 11, your institution will also need to establish and document standard operating procedures in a compliant way.

For Research Use or Manufacturing of Cell, Gene, or Tissue-Based Products.
CAUTION: Not intended for direct administration into humans or animals.