ABOUT THERMO FISHER SCIENTIFIC

Thermo Fisher Scientific is a leading global provider of cell and gene therapy development solutions. We accelerate your novel therapeutics from clinical development to commercialization. With our comprehensive portfolio of products and services we will be your dedicated partner throughout the development journey.

Key Capabilities:

  • Plasmid construction, vector production, and purification
  • Cell isolation, engineering, expansion
  • Lot release, characterization, and preservation
  • Formulation, fill, and finish
  • Expert professional support to meet process, scale, quality, and regulatory requirement

WEBINARS AND VIDEOS

  • Achieve exceptional product recovery and sterility. Learn about high-integrity surge bags, advanced leak detection, and flexible design options for your fill-finish applications.

  • Discover an animal-origin-free and chemically defined medium and feed system solution designed to revolutionize your workflow.

  • Discover how a new, chemically defined cell culture medium and feed system can maximize recombinant protein production in Chinese hamster ovary (CHO) cells, enhancing productivity and streamlining manufacturing.

  • Learn how DNA sequencing-based microbial identification supports regulatory compliance and enhances contamination control in critical environments.

  • Jean Luo, VP of Purification and Pharma Analytics, discusses innovations in bioprocessing, including the development of dPCR assays, lentiviral titer systems, chromatography resins, and supply chain.

  • Streamline and customize your cell processing workflow with automated, precise control over fluid movement and transfer parameters.

  • Discover new strategies to overcome lentiviral purification challenges with a scalable approach that maintains viral infectivity through gentle processing conditions.

  • In this roundtable discussion, a trio of distinguished experts in AAV purification and process development share their expertise and best practices in tackling and solving downstream challenges.

  • In this session of our ongoing education series on lentiviral vectors, we delve further into principles of lentiviral transduction and challenges in suspension-based lentivirus production.

  • Here, we share the development and validation of a new, highly sensitive and accurate integrated solution for detection and quantitation of host cell DNA to help meet regulatory requirements.

  • A detailed walkthrough on how to uninstall the Gibco CTS DynaCellect Bead Removal Kit when the bead removal protocol or the Gibco CTS DynaCellect magnetic separation system is completed.

  • Presented by three experts, this session examines real-world examples of how different approaches to media formulation and process conditions can influence outcomes.

  • Learn how automated closed systems and larger bioprocess containers contribute to maintaining product integrity and how rapid analytical assays can offer reliable and accurate contamination detection.

  • In this workshop, you’ll learn about various solutions, from cell isolation to cell expansion, that can support autologous and allogeneic cell therapy process needs, digital automation, and mycoplasma testing.

  • Enhance your vaccine manufacturing with peptones. Explore their benefits, analyze data-driven productivity gains, and learn integration strategies in this informative, on-demand session.

  • Explore techniques for optimizing purification toolkits for various monoclonal antibody formats. This session covers resin and buffer selection for efficient downstream process development.

  • Witness a seamless cell therapy bioprocessing workflow that reduces manufacturing time and preserves the crucial cell phenotype for scalable, effective autologous and allogeneic therapies.

  • In this presentation, one of our industry-leading customers discusses how they've successfully implemented the Applied Biosystems MicroSEQ Microbial Identification System in their laboratory testing.

  • Overview of the resDNASEQ workflow solution.

  • In this webinar, our expert speakers will discuss the types of analytical testing that can be effectively employed in the early stages of therapeutic development and subsequently scaled to meet production challenges.

  • Explore an all-in-one solution for residual DNA quantitation with a 3D lab tour with virtual demos, videos, and interactive instrument guides to experience the full workflow.

  • Optimize biopharma media strategies for consistent protein quality. Experts discuss formats, variability, and actionable analytics in this on-demand virtual roundtable.

  • Explore a future-ready solution that features advanced automation, intuitive design, and scalable solutions to streamline your bioprocessing workflows and prepare your operations for future growth.

  • Gain expert insight into the complexities of AAV purification to learn how industry leaders tackle downstream challenges, optimize workflows, and drive innovation in scalable, efficient gene therapy manufacturing solutions.

  • Discover how sustainability is transforming bioprocessing through innovative single-use technologies that help reduce environmental impact and support responsible, forward-thinking biomanufacturing.

  • Discover how digital PCR improves the accuracy of residual host cell DNA and viral titre quantification in biotherapeutic manufacturing to enhance product quality, safety, and regulatory compliance.

  • Discover key strategies for scaling biologics from bench to pilot scale and learn how to overcome challenges in process development, including control of agitation, oxygen, COâ‚‚, and nutrient supplementation.

  • Explore ZHAW’s pioneering work and collaboration in cell cultivation and bioprocessing to deliver scalable, high-performance solutions that address key challenges in biomanufacturing scale-up.

  • Explore how biosimilar development is advancing through collaboration, innovative cell culture strategies, and the use of advanced media to meet biomanufacturing goals.

  • Discover how to address evolving biotherapeutic purification challenges with a diverse resin portfolio and an intuitive Resin Selection Tool designed to streamline workflows and enhance production efficiency.

  • Confidently manage your bioprocessing systems with precision and ease by learning how to calibrate a single pump using innovative software, which ensures accurate fluid delivery.

  • Ensure accurate sensor readings with an innovative software by mastering the 2-point calibration process. Learn more about how and why regular calibration supports data integrity and compliance.

  • Explore cutting-edge single-use technologies with hands-on training at the Customer Experience Center, which is an immersive hub for innovation, learning, and bioprocessing expertise.

  • Accelerate biotherapeutic development with innovative bioprocessing equipment and automation solutions that feature single-use mixers, bioreactors, and more to streamline workflows and speed products to market.

  • Learn how to streamline bioprocess control with an innovative software's Unit Save and Load feature. Save configurations, reduce setup time, and ensure consistency across batches with this powerful tool.

  • In this webinar, results are shared from the evaluation and preliminary optimization of a mixed-mode chromatography unit operation designed for aggregate removal in flow-through mode using a high-throughput POROS resin with immobilized caprylic acid.

  • This bioprocessing online webinar series talks about analytical solutions to help accelerate bioprocessing success. There are a variety of analytical options available to help you gain deeper insights on your cell culture process.

  • This interview with a pharmaceutical analytics expert discusses key insights into advances in cell and gene therapy and the strategies used to support customers in improving their therapeutic development.

  • In this webinar, hear how Applied Biosystems AccuSEQ software serves as an advanced digital tool that can help streamline bioanalytical processes and accelerate the delivery of life-changing therapies.

  • Delve into the critical environmental and economic aspects of bioprocessing. Explore the urgent need to manage the industry’s growing plastic waste issue and a three-pronged approach to address this challenge.

  • Simplify complex biopharma downstream processing tasks using a suite of powerful, web-based calculators designed to streamline workflows and automate intricate mathematical modeling.

  • Achieving sustainability in bioprocessing labs presents distinct challenges. Learn how to reduce your environmental footprint while maintaining efficiency and avoiding extensive re-validation efforts.

  • Minimize regulatory risks and ensure compliance in the evolving biopharma sector. Watch this on-demand discussion for insights on change management, supplier collaboration, and future market trends.

  • Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Medicine, and Chief Regulatory Officer of International Society for Cell & Gene Therapy (ISCT) answer questions from the audience. They covered key regulatory topics, including the FDA’s process for finalizing draft guidances, the status of INTERACT meetings, and the use of the term “critical component” in manufacturing regulations.

  • Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Medicine, and Chief Regulatory Officer of International Society for Cell & Gene Therapy (ISCT) continue the discussion to explore the complexities of expanded access programs (EAPs) in CGT, highlighting global regulatory differences, ethical concerns, and accessibility challenges.

  • Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Medicine, and Chief Regulatory Officer of International Society for Cell & Gene Therapy (ISCT) share why the FDA’s 2024 draft guidance documents are expected to shape regulatory standards for cell and gene therapy in 2025, with topics ranging from safety testing of allogeneic cells to manufacturing practices and the use of human and animal-derived materials.

  • Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Medicine, and Chief Regulatory Officer of International Society for Cell & Gene Therapy (ISCT) share why the new administration may influence the regulatory landscape for cell and gene therapy, particularly regarding enforcement actions against unproven stem cell products and challenges to FDA authority at the state level.

  • Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Medicine, and Chief Regulatory Officer of International Society for Cell & Gene Therapy (ISCT) explain why the FDA is signaling a stronger commitment to dialogue with sponsors and advancing cell and gene therapies, particularly through early-stage engagement and regulatory guidance. Key initiatives include enhanced pre-IND meetings, increased guidance document cross-referencing, and a focus on addressing potency challenges.

  • Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Medicine, and Chief Regulatory Officer of International Society for Cell & Gene Therapy (ISCT) detail how the regulatory landscape for cell and gene therapy in 2025 will continue to be shaped by advancements in science and manufacturing and evolving regulatory guidance.

  • Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Medicine, and Chief Regulatory Officer of International Society for Cell & Gene Therapy (ISCT) explain how regulatory standards for cell and gene therapy approvals are largely consistent across regions, with North America typically leading in approvals, followed by Europe and then Asia.

CONTACT INFORMATION

Thermo Fisher Scientific Bioproduction

7305 Executive Way

Frederick, MD 21704

UNITED STATES

Contact: Hunter Tuck

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