Fully gowned quality professional inspects a BPC chamber in a clean room

Cell and gene therapy (CGT) programs are rapidly advancing from research and development to clinical trials and commercial approval. Establishing a robust, repeatable, and sustainable process early on can help accelerate development and avoid manufacturing transfer-related delays.

Thermo Fisher Scientific has a long history of partnering with cell and gene therapy developers to help advance their therapies by providing innovative technologies, technical consultation, and services. We offer closed systems and single-use technologies (SUT) developed for cell and gene therapies and biologic development that offer the flexibility required to establish new processes while enabling standardization of processes at multiple scales. In addition to instrumentation and reagents, we offer expertise, services, and custom solutions to help you translate your cell therapy from discovery to clinical research and commercial manufacturing.

The value of single-use technology for cell and gene therapy

SUT provides robust solutions that reduce the risk of contamination. It is well understood that SUT shortens turnover time for equipment, which can help accelerate development. By establishing control platforms and replicable processes, cell and gene therapy developers can more efficiently scale up their solutions through clinical trials and commercial manufacturing.

Single-use consumables

Our BioProcess Containers (BPC) are flexible containment systems made from a catalog of proprietary polymer films. These films have been specifically designed to meet the needs of bioprocessing customers and are widely used in the bioprocessing industry. In addition, we offer a wide range of rigid, single-use consumables such as cell factory systems (for adherent cell culture), bottles, and fluid transfer assemblies.

Bioprocessing equipment

As you scale your processes, we offer single-use equipment for adherent and suspension cell lines, including bioreactors and mixers from bench scale to production. These products meet specific cell and gene therapy needs, such as low shear cell processing.

The value of closed manufacturing solutions

In cell therapy, closed manufacturing systems are designed to minimize contamination risks and reduce ISO cleanroom requirements. In combination with digital connectivity, these systems enable repeatable, trackable, and GMP-compliant manufacturing processes.

For cell therapy manufacturing, we currently provide multiple closed systems with SUT consumables, including the Gibco CTS Rotea Counterflow Centrifugation System and the Thermo Scientific HyPerforma Rocker Bioreactor. The Rotea System is a closed and automated cell-processing system that provides process flexibility and enables cell separation, wash, concentration, and buffer exchange.

Discover closed, scalable cell processing and electroporation systems for your GMP iPSC research and manufacturing

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Gibco CTS Rotea Counterflow Centrifugation System

세포 치료제 개발을 위한 유연성 있는 compact한 closed cell processing system

  • Process flexibility – 세포 분리, 세척 및 농축을 위해 사용자가 직접 프로토콜을 제작 및 최적화할 수 있는 소프트웨어가 내장되어 있습니다.
  • High cell recovery and viability – 세포 회수율을 95% 이상 유지하면서 세포 생존율을 유지합니다.
  • Low output volumes – 독점 기술을 사용하여 5 mL 이하로 농축이 가능합니다.
  • Research through commercial manufacturing – 멸균 처리된 closed single-use kit를 이용하며, OPC-UA 인터페이스를 통해 21 CFR 제 11 규정을 준수하는 시스템과 연결할 수 있습니다.

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Gibco CTS Xenon Electroporation System

GMP 가이드에 준수한 세포 치료제 개발을 위한 스케일 확장이 가능한 closed electroporation system

  • High speed and large volume – 25분 내 2.5 x 109 T cells/25 mL의 transfection이 가능합니다.
  • Scalable, proven performance and viabilityCTS TrueCut Cas9 Protein을 이용해 최대 90%까지의 gene knockout과 80% cell viability를 확인하였습니다.
  • Process flexibility – 다양한 세포 유형 및 payload에 대한 electroporation 프로토콜을 사용자가 직접 제작 및 최적화할 수 있는 소프트웨어가 내장되어 있으며, 공정 개발부터 상업 생산까지 가능합니다.
  • Efficient nonviral transfection – Xenon MultiShot Electroporation Cartridge는 PVC 또는 C-Flex™ 튜브에 sterile welding을 가능하게 합니다.

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Closed system-compatible media and reagents

Many of our CTS media and reagents designed for cell and gene therapy applications are available in a format designed to be used in your closed system workflow. Closed system-compatible media is provided in a BioProcess Container (BPC) designed with a variety of options suitable for aseptic integration into your workflow including sterile welding, MPC, Luer lock, and a septum port.

Control and data management

To control your process and manage your data, we offer the HyPerforma G3Lab Controller and the TruBio control system, based on the robust DeltaV platform, helping you to develop GMP-compliant processes as you eliminate costly and time-consuming tech transfers later in your process.

Whether you are establishing a new process or need to improve your existing one, contact us to discuss how we might be able to help.

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