Thermo Fisher Scientific Launches New Solution to Help Cell Therapy Manufacturing

Thermo Fisher Scientific Inc., the world leader in serving science, unveiled October 17th the Gibco™ CTS™ DynaCellect™ Magnetic Separation System (DynaCellect) to help cell therapy developers easily move from process and clinical development to commercial manufacturing. 

This next-generation cell isolation, cell activation, cell depletion and Dynabeads™ magnetic beads removal instrument provides a scalable, flexible, automated and closed system to help optimize the cell therapy manufacturing process. As a result, DynaCellect helps ensure the right cells are isolated and failures in manufacturing are minimized. With the cell therapy market poised for rapid growth, this evolution in cell therapy manufacturing can support the commercialization of high performing therapies as well as the development of the next class of cell therapy breakthroughs.

Cell and Gene Therapy, the New, Better Ways of Treating Life Threatening Diseases

Cellular therapy (CT) is the transplantation of human cells to replace or repair damaged tissue and/or cells. With new technologies, innovative products, and limitless imagination, many different types of cells may be used as part of a therapy or treatment for a variety of diseases and conditions. Some of the cells that may be used include hematopoietic (blood-forming) stem cells (HSC), skeletal muscle stem cells, mesenchymal stem cells, lymphocytes, dendritic cells, and pancreatic islet cells. Potential applications of cell therapies include treating cancers, autoimmune disease, urinary problems, and infectious disease, rebuilding damaged cartilage in joints, repairing spinal cord injuries, improving a weakened immune system, and helping patients with neurological disorders.

Cell and gene therapy represent overlapping fields of biomedical research with similar therapeutic goals, which target DNA or RNA inside or outside the body. Both approaches seek to modify genetic material to improve functioning or fight disease. Specifically, gene therapy uses genetic material, or DNA, to manipulate a patient’s cells for the treatment of an inherited or acquired disease. While cell therapy is the infusion or transplantation of whole cells into a patient for the treatment of an inherited or acquired disease. 

Companies Are Interested in Developing New Advanced Therapies

Since applicability is wide, the interest of various companies to develop such therapies is also elevated.

Back in 2018, a Series C funding round by SQZ Biotech – a cell therapy firm developing new treatments for multi-therapeutic areas – was oversubscribed. The company raised $72 million, three times more than the sum raised in its Series B round funding in 2016. 

The funding round could be an indicator of investor confidence in the growth of cell therapy, even though SQZ Biotech’s drug program was still in its infancy. The funds were to be used for the first step towards taking cell therapy for clinical trials for oncology and autoimmune indications. 

In February of 2022, Code Biotherapeutics, Inc. (Code Bio), a biotechnology company pioneering targeted non-viral delivery of genetic medicines, announced a collaboration and option agreement with Takeda to leverage Code Bio’s proprietary targeted 3DNA® non-viral genetic medicine delivery platform to design and develop gene therapies for rare disease indications. ​

Through the agreement, Takeda and Code Bio agreed to design and develop a targeted gene therapy leveraging Code Bio’s 3DNA platform for a liver-directed rare disease program, plus conduct additional studies for central nervous system-directed rare disease programs. Takeda has the right to exercise options for an exclusive license for four programs.

Under the terms of the agreement, Code Bio was to receive double-digit million dollars in upfront, near-term milestone and research funding payments.

Dynacellect System Delivers Exceptional Performance, High-Throughput Capacity and Process Flexibility

Designed to be used with Dynabeads, the DynaCellect system delivers exceptional performance, high-throughput capacity and process flexibility while enabling an end-to-end closed process. Cell therapy manufacturers utilizing the DynaCellect system can leverage a highly efficient workflow that reliably delivers high-performing target cells. With processing speed and scalability, this technology helps manufacturers quickly optimize their protocol design and move into commercial production. For patients, this means more options for effective new therapies they can trust.

“The future of cell therapy is bright, and our team is focused on innovations that expedite breakthroughs and, ultimately, help patients,” said Tiffani Manolis, vice president and general manager, cell culture and cell therapy, Thermo Fisher Scientific. “DynaCellect helps minimize the potential for errors while accelerating the manufacturing process. This allows our customers to commercialize therapies faster and potentially save more lives. It is a perfect example of how our innovations deliver on our commitment to helping our customers make the world healthier.”

Cell Therapy Manufacturers Can Achieve Greater Than 86% Isolation Efficiency

DynaCellect’s automated system delivers robust yet precise cell isolation, cell activation, cell depletion and Dynabeads removal. Using the Gibco CTS DynaCellect Cell Isolation Kit with Gibco CTS Dynabeads CD3/CD28 magnetic beads, cell therapy manufacturers can achieve greater than 86% isolation efficiency of activated target T cells with more than 96% purity while having no effect on cell viability*.

Automated Dynabeads removal using the Gibco CTS DynaCellect Bead Removal Kit results in over 91% target cell recovery*. Magnetic bead removal is also accomplished faster, with bead removal time being reduced by up to 80%*.

DynaCellect can be utilized as a stand-alone device or integrated with the Gibco CTS ROTEA™ Counterflow Centrifugation System and the Gibco CTS XENON™ Electroporation System as part of a modular, closed and automated cell therapy manufacturing workflow, depending on the optimal protocol design for the therapy. The system also offers flexible process scalability, supporting both autologous and allogeneic workflows.

This is not the first big announcement for Thermo Fisher Scientific in 2022. In March, the company launched the CE-IVD marked Ion Torrent Genexus Dx Integrated Sequencer, an automated, next-generation sequencing (NGS) platform that delivers results in as little as a single day. Designed for use in clinical laboratories, the fully validated system enables users to perform both diagnostic testing and clinical research on a single instrument.

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.