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Translational research services

De-risk and accelerate cell and gene therapy development from discovery to clinical manufacturing

Translational research for advanced therapies involves the application of cell- and gene-based scientific discoveries and knowledge generated in the laboratory to the development and large-scale production of innovative therapeutics to be used in clinical settings.

The intricacies of manufacturing and characterizing advanced therapies present inherent challenges in maintaining product consistency throughout the research and development, preclinical, clinical, and commercialization phases. The use of suboptimal materials and processes in the discovery stage can significantly disrupt progression to later clinical stages, leading to timeline delays and increased costs.

At Thermo Fisher Scientific, our translational research services help produce small-scale molecular biology, viral vector, and cell therapy materials utilizing scaled-down processes that mirror cGMP workflows. This helps to proactively mitigate risk and enhance the transition from discovery to clinical research and ultimately commercialization, enabling an accelerated timeline from bench to bedside.

A “start-with-end-in-mind” approach helps de-risk advanced therapy development

When embarking on a new cell- and gene-based therapy development project, it’s crucial to keep the end goal in mind: producing larger-scale, GMP-level batches that satisfy regulatory requirements to accelerate patient access to life-saving therapies. Translational services help achieve this goal through the early establishment of standardized processes and qualifiable assays that avoid delays during the transition to larger-scale, GMP-level production.

Translational services offer:

  • Access to emerging technologies through R&D, operational, and regulatory support
  • Use of research use only (RUO) materials with cGMP-equivalent counterparts
  • Qualified equipment, robust training, starting and raw materials vendor management, and processes to monitor performance drift
  • Scaled-down processing models using qualified reagents and analytics
  • Robust in-process testing and monitoring
  • Methods based on the latest regulatory guidance, continuous understanding, and incorporation of regulatory requirements

Our translational research services generate material for research use only (RUO), not for IND-enabling studies or diagnostics purposes.

Our molecular biology services support viral vector and cell therapy translational services to ensure high-quality/quantity materials generation and compliance with regulatory requirements. Specifically, our services include:

 

  • Plasmid modification or cloning (antibiotic resistance swapping, deletion/mutation of undesired sequence(s), etc.)

  • Plasmid production (up to 20 mg)

  • Plasmid purification (silica column, liquid chromatography)

  • Plasmid concentration and formulation (UF, TFF)

  • Standard analytics (quantity, integrity, purity)

  • Additional analytics (identity, purity, safety, etc.)
Molecular biology services

Large-scale plasmid DNA manufacturing services

We produce plasmid DNA for a wide variety of R&D, clinical, and commercial bioprocessing applications. Plasmids can be manufactured by leveraging our proven platform process or via a customized production process. We can tailor our services for your unique molecule to improve its performance efficiency and scale up as needed.

Learn more about our plasmid DNA manufacturing services here.

Our viral vector translational services use standardized methods and scaled-down, cGMP-compatible processes for adeno-associated virus (AAV) and lentiviral (LV) production. Plasmids that are designed and engineered for purpose through molecular biology services are transfected in clonal, documented, and qualified HEK293 cell lines. The cells are grown in suspension and serum-free cell culture (up to 10L). Throughout the process, qualifiable analytics with controls and standards are utilized to characterize the viral vectors.

Our viral vector translational services include:

  • Cell expansion

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  • Plasmid transfection (transient transfection)

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  • Virus production (AAV, LV)

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  • Scale-specific virus purification (PEG concentration, affinity and ion-exchange chromatography, tangential flow filtration [TFF] concentration)

  • Characterization of viral vectors
Viral vector translational services

End-to-end viral vector development and manufacturing services

In addition to viral vector translational services, we provide support for all other aspects of the viral vector-based therapy development and manufacturing journey. That includes process development, clinical and commercial manufacturing, fill/finish services, regulatory service, and cold chain logistics. Learn more about our end-to-end viral vector development and manufacturing solutions and 20+ years of industry experience here.

Our services enable the accelerated and effective translation of cell therapy research through the early establishment of standardized processes and qualifiable analytics. Our flexible, à la carte platform for immune and stem cells supports the optimization and establishment of your cell therapy manufacturing process with continual R&D, operational, and regulatory support.

  • Process optimization and establishment
  • Proof-of-concept studies
  • Raw material assessment
  • Qualifiable analytics used in cGMP manufacturing
  • Assay development and establishment
  • Quality management system
Plasmid cGMP manufacturing

Our extensive experience working with stem cells and immune cell therapies allows for comprehensive workflow support (components, processing systems, in-process testing, analytics) to maximize the quality and efficiency of your translational therapy. 

  • Autologous and allogenic platforms
  • Reprogramming/iPSC generation and expansion
  • Stem/immune cell isolation and expansion
  • Stem/immune cell modification (viral or non-viral)
  • Wash/concentration and formulation
  • Research cell banking
Plasmid cGMP manufacturing

End-to-end cell therapy development and manufacturing services

In addition to cell therapy translational services, we provide support for all other aspects of the cell therapy development and manufacturing journey. Learn more about our end-to-end cell therapy development and manufacturing solutions here. 

Elevate your translational research with the industry’s leading research and development team

Our dedicated advanced therapy research and development team of 60+ members — including more than 20 PhD scientists spanning diverse disciplines such as virology, biochemistry, molecular biology, cell biology, and microbiology — is committed to advancing the cell and gene therapy development and manufacturing landscape.

Our mission involves the meticulous engineering of next-generation viral and non-viral vector, cell therapy, and plasmid DNA platforms, as well as developing more precise and qualifiable analytical assays. We are also establishing new benchmarks for quality standards and extending regulatory support for cGMP manufacturing.

Our industry-leading knowledge and expertise is also utilized to consult and support early-stage developers through our translational research services.

Gain insight into our team's recent scientific publications:

Pharmaceutical services science and technology facility in San Diego, California, USA

 

Our 32,000-square-foot facility is located at the heart of San Diego’s buzzing biotechnology hub. The state-of-the-art site supports molecular biology, viral vector, and cell therapy translational services, and also performs CDMO R&D studies.

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