Achieve optimal bioprocessing outcomes

With a proven portfolio of solutions that span discovery through large-scale commercial production, we bring process intensification across your upstream and downstream workflows, without compromising on quality. And to stay ahead of future bioprocessing needs, we are focused on working with customers and utilizing our unique capabilities, like open architecture engineering and customization, to provide the right solutions to achieve optimal bioprocessing outcomes. That’s our commitment to you and it’s what we call Bioprocessing by Design.

Featured products and services:

  • Thermo Scientific Single-Use Technologies
  • Thermo Scientific Automation and Control Solutions
  • Gibco Cell Culture Products and Services
  • Thermo Scientific Chromatography and Protein Purification Solutions
  • Applied Biosystems Contaminant and Impurity QC Testing
  • Thermo Scientific Production Chemicals, Sourcing, and Custom Packaging Services
  • Thermo Scientific Direct Materials Supply Chain Services

Gene therapy: It’s in our DNA.

With Thermo Fisher Scientific, you have the support you need to push your therapeutic development strategies a step further. We offer a suite of scalable and robust solutions for all stages of the gene therapy workflow, from development through commercialization, to help you accelerate your development and meet regulatory standards with confidence. With our help, you can bring your discovery to life and accelerate delivery of live-saving, breakthrough therapies.

ABOUT THERMO FISHER SCIENTIFIC

Thermo Fisher Scientific

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue exceeding $25 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, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues 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 and Patheon. For more information, please visit www.thermofisher.com.

BioProduction Division

With a proven portfolio of solutions that span discovery through large-scale commercial production, we bring process intensification across your upstream and downstream workflows, without compromising on quality. And to stay ahead of future bioprocessing needs, we are focused on working with customers and utilizing our unique capabilities, like open architecture engineering and customization, to provide the right solutions to achieve optimal bioprocessing outcomes. That’s our commitment to you and it’s what we call Bioprocessing by Design.

WEBINARS AND VIDEOS

  • Expert panelists provide detailed answers to questions submitted in real time by our registrants providing insightful responses regarding analytical challenges to automation, test automation, and more.

  • Expert CTO's detail how automation improves safety and efficiency when collecting source material.

  • CTO experts debate autologous and allogeneic, and how automation improves the CAR-T cell process every step from collection to infusion. They also discuss the major ways AI optimizes automation.

  • Experts working on robust pipelines that focus on various therapeutic areas explain how process automation looks different per therapeutic focus area.

  • Two Chief Technical Officer's for therapeutic organizations cover the various ways in which automation helps to reduce risk and why closing systems and reducing the number of manual manipulations is so critical.

  • Investigate the importance of technology as it relates to automation and standardization within cell therapy manufacturing. The panelists in this discussion cover solutions and services needed for process automation in CGT.

  • Experts explain the general benefits of automated manufacturing as well as the key areas that need improvement to scale up quality and to help reduce the costs of therapeutics.

  • During each Cell & Gene Live, our audience has the opportunity to submit real-time questions for our expert panelists. Watch and listen as Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO and Adora Ndu, PharmD, JD, Chief Regulatory Affairs Officer at BridgeBio provide detailed, insightful responses to our audience questions on everything from regulatory timelines to successful and unsuccessful strategies needed to convince the regulators that current regulation requirements are either inappropriate or alternatively excessively burdensome for cell and gene-based therapies.

  • There are more than 7,000 unique, rare diseases recognized in the United States, and 300 million people worldwide living with a rare disease; patients often experience a long journey to receive their diagnosis. Our expert panelists, Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO and Adora Ndu, PharmD, JD, Chief Regulatory Affairs Officer at BridgeBio, examine the regulatory requirements for safety and efficacy demonstration and identify the gaps in regulatory oversight that require clearer guidance.

  • By 2030, 60 CGTs are expected to reach regulatory approval. One of the biopharmaceutical industry's most closely watched regulatory developments is the FDA’s reauthorization of the Prescription Drug User Fee Act (PDUFA) or PDUFA VII, as it provides resources for the FDA and CBER to have the capacity to provide feedback on development and review submitted applications, among other critical activities. During our Cell & Gene Live, Tackling Cell and Gene Therapies’ Top 3 Regulatory Impediments, Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO and Adora Ndu, PharmD, JD, Chief Regulatory Affairs Officer at BridgeBio break down how PDUFA VII, Fiscal Year 2023 Omnibus Appropriations Bill, and more will impact the cell and gene therapy field in the next few years.

  • Host and Moderator, Erin Harris, Chief Editor of Cell & Gene, began this Cell & Gene Live, Tackling Cell and Gene Therapies’ Top 3 Regulatory Impediments, featuring Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO and Adora Ndu, PharmD, JD, Chief Regulatory Affairs Officer at BridgeBio, by asking the experts to highlight the main opportunities where the cell and gene therapy industry is working to meet regulatory requirements. They cover accelerated and expedited designation of regenerative medicines, navigating the regulatory requirements around the root causes of genetic disease by repairing or replacing a patient’s genes, and much more.

  • During this segment of Cell & Gene Live, Tackling Cell and Gene Therapies’ Top 3 Regulatory Impediments, Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO and Adora Ndu, PharmD, JD, Chief Regulatory Affairs Officer at BridgeBio detail their own experiences with roadblocks with regulators and how they and their teams worked to overcome them.

  • Many cell and gene therapies are intended for diseases and conditions that primarily impact pediatric patients, requiring the prospect of direct benefit to individual subjects enrolled in the trial.  In the absence of good animal models, there may be challenges demonstrating the prospect of direct benefit.  During this segment of Cell & Gene Live, Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO discusses novel approaches to consider going forward.

  • To accelerate the delivery of life-saving therapeutics, it is essential to evaluate ways to maximize efficiencies, while minimizing risk, to stay up to speed with the growing demand.

  • As more products are moved into single use fermenters, there is greater need to improved oxygen delivery closer to or beyond the abilities of stainless-steel vessels.

  • Learn how leading biopharma companies such as Sanofi and single-use solutions provider Thermo Fisher Scientific are addressing supply challenges and developing collaborative processes. 

  • Cell and gene therapy developers have felt the pressure to optimize processes and streamline activities in order to ensure clinical and commercial success of these critical therapies.

  • Due to the urgent demand for vaccines and treatments, the biopharmaceutical industry is experiencing disruptive changes and increased demand on resources that are requiring a significant operational transformation. To accelerate the delivery of life-saving therapeutics, it is essential to evaluate effective ways to maximize efficiencies and increase capacity while minimizing risk. Flexibility is critical in bioprocessing today to stay up to speed with the quickly shifting needs of the industry.

  • The Single-Use Technologies (SUT) business at Thermo Fisher Scientific is helping our customers in their fight against SARS-CoV-2 by providing assurance of supply. This video discusses our escalation routes through the Coronavirus Command Centre, our SUT capacity expansions and contains a customer testimonial from AGC Biologics.

CONTACT INFORMATION

Thermo Fisher Scientific Bioproduction

7305 Executive Way

Frederick, MD 21704

UNITED STATES

Contact: Deirdre Reardon

FEATURED ARTICLES