Multiparametric selection enables GMP-ready cell production

The landscape of cell and gene therapies has witnessed remarkable advancements, with significant strides made in the development and application of these innovative treatments. A crucial aspect of this progress is the ability to sort and isolate cells with high precision and purity. Traditional flow cytometers, though effective in research settings, often fall short when it comes to GMP-compliant cell production environments. Addressing this gap, Sony Biotechnology introduces the CGX10 Cell Isolation System, a state-of-the-art, GMP-ready cell sorter designed specifically for clinical-grade cell and gene therapy manufacturing.

User pain points in cell and gene therapy manufacturing

Limitations of traditional technologies

Traditional cell sorting technologies have several limitations that impede their effectiveness in a GMP-compliant environment. "One particular technology that was used in the past was magnetic bead (based) isolation of populations,” notes Jerry Barnhart, Manager of Field Applications at Sony Biotechnology. “This was great if you had one single marker or you didn’t need super high purity, but a lot of times you have to really use multiple markers and get very high purity.” This restriction hampers the ability to achieve high-purity cell isolation, which is critical for effective therapies.

The complexity of traditional flow cytometers also poses significant challenges. These systems often require extensive training and expertise in flow cytometry, making them less accessible to GMP operators who may not have specialized training. This issue is compounded by high turnover rates in GMP environments, necessitating frequent and time-consuming training sessions.

The need for high-speed, high-purity cell sorting

In cell and gene therapy manufacturing, isolating rare cell populations is particularly challenging due to the inherent rarity of these cells. "Some of the main challenges in the field of therapy product manufacturing are identifying and isolating rare populations,” Barnhart explains. “So, if you need to get a certain number of cells, but you have a rare starting population, that is going to require a very large amount of starting sample."

Traditional technologies often offer either the ability to process large sample sizes at the expense of purity or require multiple sorting steps to achieve high purity, which can be time-consuming and inefficient. The need for a solution that combines high-speed processing with high-purity cell isolation is evident.

The CGX10 Cell Isolation System

Multiparametric selection for superior purity and flexibility

The CGX10 Cell Isolation System addresses these pain points by enabling multiparametric selection, which allows for the identification and isolation of cells based on multiple biomarkers. This capability is a significant advancement over traditional technologies that typically limit users to one or two markers. Barnhart highlights this advantage, stating, "Not only can you use multiple parameters to identify the cells of interest, you can also sort at high speeds and get really high purity.”

By utilizing multiple biomarkers, the CGX10 ensures higher purity of isolated cells and facilitates the elimination of non-target or therapeutically ineffective cells, such as over-differentiated T cells. This capability is crucial for the development of effective cell-based therapies, where the quality and purity of isolated cells directly impact therapeutic outcomes.

High-speed processing without compromising purity

One of the standout features of the CGX10 is its ability to process large sample sizes quickly while maintaining high purity levels. "The CGX10 offers the best of both worlds,” Barnhart emphasizes. “You can run multiple units in parallel and process large amounts of samples quickly and still obtain a pure rare population." This dual capability is particularly beneficial for isolating rare cell populations, where the volume of starting material can be substantial.

The system's high-speed processing capabilities do not come at the expense of cell viability. The CGX10 is designed to minimize shear stress and electrically-induced damage, which are common issues with conventional flow cytometers. This design consideration ensures that the isolated cells remain viable and functional for therapeutic applications.

Designed for GMP compliant labs and for ease of use

Simplifying operations for GMP environments

Recognizing the challenges associated with training GMP operators, the CGX10 is designed to be user-friendly and intuitive. "The design aspects allow flow sorting to be used in GMP environments by GMP operators, where we know that training is complicated and a time-consuming,” shares Marc-Aurele Brun, Senior Project Manager for Cell Therapy at Sony Biotechnology. “We designed the CGX10 from scratch so anyone in GMP (laboratories) can use it.”

As a result, the CGX10 is designed to be fully automated and include on-screen guidance and prompts instructing the operator step by step. These automated features and on-screen prompts simplify the cell isolation process, reducing the need for extensive training and allowing GMP operators to perform tasks efficiently. This ease of use is further enhanced by the touch screen operation, which eliminates the need for a keyboard and mouse, thereby saving space and simplifying the workflow.

Ensuring sterility and compliance

The CGX10 is a fully closed system, which is a critical feature for maintaining sterility in GMP-compliant environments. The tubing kits used in the system are sterilized using the Ethylene Oxide Gas (EOG) sterilization process, ensuring that they are free from contaminants. The closed mode operation protects cells from the external environment, significantly lowering the risk of contamination.

Furthermore, all consumables that come into contact with cells are manufactured and tested in ISO 13485 standard-compliant facilities. Certification is available for each lot of consumables, supporting work in compliant facilities and providing assurance of quality and safety.

Transitioning from process development to cell production

The CGX10 Cell Isolation System offers unparalleled flexibility, enabling a smooth transition from process development to cell production. Its innovative design and superior cell isolation capabilities make it an ideal choice for clinical-grade cell and gene therapy manufacturing.

Scalability and efficiency

The system's ability to run multiple units in parallel allows for scalable operations, accommodating the needs of both small-scale research and large-scale manufacturing. This scalability ensures that as cell therapy programs progress from research to clinical and commercial stages, the CGX10 can meet the increasing demands efficiently.

Supporting regulatory compliance

Compliance with regulatory requirements is a fundamental aspect of GMP environments. The CGX10 is designed with compliance in mind, featuring tools that support 21 CFR Part 11 compliance. This includes electronic records and signatures, ensuring that all operations are documented and traceable, which is essential for meeting regulatory standards.

In summary, the CGX10 Cell Isolation System from Sony Biotechnology is a revolutionary tool that is designed to address the critical needs of cell and gene therapy manufacturing. By offering multiparametric selection, high-speed processing, and GMP-compliant features, the CGX10 overcomes the limitations of traditional cell sorting technologies. It provides laboratory managers, research scientists, and pharmaceutical manufacturers with a reliable, efficient, and user-friendly solution for isolating high-purity cells, ultimately enhancing the development and production of effective cell-based therapies.

Watch the full video of the interview with Jerry Barnhart and Marc-Aurele Brun: