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
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![23_01_BPL_RegWebinar_1920x1080_Seg09]( "IND Submission Advice From The Front Lines")
NDA Partners Regulatory Affairs Expert Consultant Daniela Drago, Ph.D. and Umoja Biopharma VP of Regulatory Affairs Helen Kim share parting shots and nuggets of IND submission wisdom, and respond to a few final audience questions, in this final segment of the Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray.
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![23_01_BPL_RegWebinar_1920x1080_Seg08]( "Resources For Successful IND Submissions")
In this segment of the Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray, NDA Partners Regulatory Affairs Expert Consultant Daniela Drago, Ph.D. and Umoja Biopharma VP of Regulatory Affairs Helen Kim offer several of their go-to resources for guidance when preparing an IND submission.
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![23_01_BPL_RegWebinar_1920x1080_Seg07]( "So, You’ve Been Put On Clinical Hold…")
As the frequency of clinical holds increases, so do the chances it’ll happen to you. What’s a biopharma leader to do if it happens? Umoja Biopharma VP of Regulatory Affairs Helen Kim and NDA Partners Regulatory Affairs Expert Consultant Daniela Drago, Ph.D. offer advice on direct engagement with the FDA to expedite the release of a clinical hold.
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![23_01_BPL_RegWebinar_1920x1080_Seg06]( "How To Avoid A Clinical Hold")
Having covered what a clinical hold is and the disruption they cause, Umoja Biopharma VP of Regulatory Affairs Helen Kim and NDA Partners Regulatory Affairs Expert Consultant Daniela Drago, Ph.D. dig into how biopharmas can avoid them from the outset in this segment of the Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray.
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![23_01_BPL_RegWebinar_1920x1080_Seg05]( "IND Submissions Are On The Rise")
During this segment of the Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray, we asked our live audience about their near-term IND submission plans. Our panelists, NDA Partners Regulatory Affairs Expert Consultant Daniela Drago, Ph.D. and Umoja Biopharma VP of Regulatory Affairs Helen Kim, reflected on the uptick in submissions to the FDA in recent years and prognosticated on the trend.
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![23_01_BPL_RegWebinar_1920x1080_Seg04]( "The Impact Of The Clinical Hold")
In this segment of the Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray, Umoja Biopharma VP of Regulatory Affairs Helen Kim and NDA Partners Regulatory Affairs Expert Consultant Daniela Drago, Ph.D. discuss the ramifications of a clinical hold on your study progress, investor perception, and timelines.
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![23_01_BPL_RegWebinar_1920x1080_Seg03]( "Why Clinical Holds Happen")
The volume of clinical holds doled out by the FDA has skyrocketed in recent years. In this segment of the Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray, NDA Partners Expert Consultant Daniela Drago, Ph.D. and Umoja Biopharma VP of Regulatory Affairs Helen Kim explain clinical holds and discuss why they happen.
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![23_01_BPL_RegWebinar_1920x1080_Seg02]( "Animal Testing & Tox: What’s Required Today?")
In this segment of the Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray, Umoja Biopharma VP of Regulatory Affairs Heln Kim entertains audience questions on FDA toxicology and animal study requirements in light of the Reducing Animal Testing Act passed in December, 2022.
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![23_01_BPL_RegWebinar_1920x1080_Seg01]( "Pre-IND Prep: A Primer")
Meet Daniela Drago, Ph.D. and Helen Kim, regulatory affairs experts at NDA Partners and Umoja Biopharma, respectively, in the opening segment of our recent Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray. Here, Drago and Kim address the value of a pre-IND meeting and the resources required of successful submissions.
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![1_97D9286E493718B77D4B7019D4D8C9E6]( "Accelerating mAb Development To Meet Increase In mAb Approvals")
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.
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![1_20C2B556099B9850F3EE2B6F19A64365]( "Enabling GMP Production with Enhanced Single-Use Fermentors")
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.
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![1_E4230FE18AC53E3EB10BF0F75476EA06]( "A Collaborative Path To Single-Use Supply Assurance")
Learn how leading biopharma companies such as Sanofi and single-use solutions provider Thermo Fisher Scientific are addressing supply challenges and developing collaborative processes.
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![1_EB03658D8EFAA5237EAC7AAF8B06D5A8]( "Optimizing Cell & Gene Therapy Manufacturing Post-COVID")
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.
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![1_797E2FE2ECF9A8CD8C8F91ECC0319FFB]( "Accelerating Progress: Key Considerations For CDMOs To Maximize Productivity And Scalability")
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.
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![Thermo]( "Single-Use Technologies In The Battle Against SARS-CoV-2")
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
BROCHURES
FEATURED ARTICLES
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![GettyImages-1331571740-supply-chain-sourcing-logistics-tracking]( "Reduce Supply Chain Disruptions With Second Sourcing")
Follow one CDMO's collaboration with Thermo Fisher Scientific to combat supply chain risks after one of the high-volume raw materials critical to their manufacturing process experienced a global shortage.
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![GettyImages-1275317360-lab-cell-gene-research-scientist-development-discovery]( "Tailoring The Expansion Process And Process For Longer Workflows")
This article addresses the focus on the variability and importance of having robust young (TCM) populations for efficacious therapies.
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![Cell expansion iStock-1090837544]( "Improving Workflow Automation And Process Control")
Learn about optimizing your T cell manufacturing process and reducing operating costs with rocking bioreactors using CTS OpTmizer T Cell Expansion SFM.
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![T cells cancer cells]( "The Impact Of Media And Stirred-Tank Bioreactors On Cell Therapy Manufacturing")
Rocking motion bioreactors have long been the mainstay in T cell therapy, but stirred-tank bioreactors have garnered a lot of excitement because of several potential advantages.
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![Cell culture pipette GettyImages-1173385629]( "Deliver Product Quality, Enhance Productivity In CHO-K1, CHO-S Cells")
Early identification of a robust, commercially available, optimized platform medium and cell line–specific feed could be the keys to achieving strong productivity and delivering product to market more rapidly.
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![GettyImages-673805662-cell-processing-lab-development]( "Improve Productivity In CHO-K1, CHO-S, And DG44 Cells")
This commercially available platform can enhance process productivity and reduce development time, thereby enabling potential reductions in manufacturing costs and accelerating time-to-market.
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![Thermo Modularized image]( "Single-Use Solutions For Research And Process Development")
Can supply chain assurance be maintained while offering an array of possibilities to achieve complex process designs? Learn if you could benefit from a modularized, standardized single-use manifold design.
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![Scientist laboratory ipad iStock-1207515232]( "Reducing Risk During CAR T Cell Therapy Development And Manufacture")
It is essential to identify potential areas for optimization early in CAR T cell therapy development—particularly with respect to equipment, reagents, and analytics.
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![iStock-1296757866-research-lab-flask-microscope]( "Diploid Serum-Reduced Medium System Supports Viral Production")
Results demonstrate that the system can enable vaccine manufacturers to reduce the use of FBS while achieving potential increases in viral specific productivity with diploid cells.
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![Cells iStock-999018482]( "Reduce Or Eliminate Serum Use In Vaccine Production")
The use of this Diploid Growth Serum-Reduced Medium (SRM) helps vaccine manufacturers using diploid cells meet their production forecasts while reducing production costs and serum use.
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![iStock-1067806062-vial-development-manufacturing]( "Optimize Allogeneic Workflow, Cell Proliferation")
This application note outlines the capabilities of CTS OpTmizer Pro SFM compared with a control medium in both diseased patients’ and healthy donors’ cells.
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![T-cell iStock-1159808506]( "Human Regulatory T Cell Expansion And Measurement Of Function")
Regulatory T cells (Tregs) are a subpopulation of T cells with the unique ability to suppress the activation of effector T cells and thereby prevent T cell function. This application note describes an optimized protocol for activation and expansion of flow-sorted Tregs with Gibco™ CTS™ Dynabeads™ Treg Xpander.
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![Pipette With Cell Culture Plate iStock-520238063]( "Bacto CD Supreme FPM Consistently Supports Higher Growth And Plasmid Production In E. coli")
Traditional microbial media for E. coli often contain animal-origin components and are complex. Stemmed from an overall industry drive to develop animal origin–free (AOF) and chemically defined (CD) media, Gibco™ Bacto™ CD Supreme Fermentation Production Medium (FPM) supports process flexibility and consistency in production. Read the results of a head-to-head comparison between Bacto CD Supreme FPM and Terrific Broth (TB), a traditional microbial medium.
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![Cell]( "One-Step Isolation And Activation Of Naive And Early Memory T Cells With CTS Dynabeads CD3/CD28")
In this application note we demonstrate nearly 100% recovery of naive and early memory T cells using Gibco™ CTS™ Dynabeads™ CD3/CD28 beads. This one-step process of simultaneous T cell isolation and activation yields pure and uniformly activated T cells.
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![iStock-1159995989-cell-gene-map]( "Understanding Perfusion Terminology")
To evaluate whether a perfusion application will work in a production process, standardized terminology is critical. This white paper explains key terms that are essential for understanding the process.
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![DNA Gene Strand]( "Outsourcing Trusted-Weight Dry Powder Chemicals To Support Expansion")
The gene therapy division of a major pharmaceutical manufacturer was looking for ways to overcome capacity constraints due to the increased production demands for process liquids and buffers. Non-core manufacturing activities, including the weigh and dispense steps in the process liquid and buffer preparation, were identified as bottlenecks impacting the overall production schedule. The proposed solution would provide ready-to-hydrate, trustedweight dry powder chemicals. Read how the customer benefited from the procurement of larger lot sizes that were not capable of being handled within their facility, resulting in annual savings for raw materials and QC testing.
