
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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Build scalable material sourcing strategies for R&D and early phases through to commercialization and learn how to accelerate the development process and ensuring the scalability of your biologics.
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Therapeutic monoclonal antibodies (mAbs) show great promise for treating a variety of diseases. Watch this expert discussion on challenges and obstacles in mAbs development, optimizing processes, and selecting the right partner.
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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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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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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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Umoja Biopharma's VP of Regulatory Affairs and an NDA Partners Regulatory Affairs Expert Consultant have come together to dig into how biopharmas can avoid clinical holds from the outset
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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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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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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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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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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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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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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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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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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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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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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.
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What does pressure to address critical challenges of speed, scale, and supply mean for technologies enabling production, and how does it impact the future of vaccine and biotherapeutic manufacturing?
CONTACT INFORMATION
Thermo Fisher Scientific
7305 Executive Way
Frederick, MD 21704
UNITED STATES
Contact: Deirdre Reardon
HOT PRODUCTS
- Microbial Identification For Control In Environmental Monitoring
- Moving Forward In Microbial Identification
- The Way Forward In Mycoplasma Detection
- Potent, Selective Modulators Of Protein Functions
- Supporting Bench To Production Applications For Multiple Industries
- Chemical Products And Services At A Glance
- Bioproduction Regulatory Consulting Capabilities
- Evolve The Future Of Cell Therapy Manufacturing
- Antibody Therapeutics Purification
- Process Liquid Preparation Services
- Expand T Cells For Allogeneic Therapies With CTS OpTmizer Pro SFM
- ONE Lentiviral Vector Production System
- Single-Use BioProcess Containers Brochure
- Best Practices For Evaluating A Perfusion Medium
FEATURED ARTICLES
- Transitioning From Using RUO To cGMP Chemicals For Clinical Trials
- Critical Considerations For Buffer Preparation
- Successful Planning: Process Liquid & Buffer Preparation
- Single-Use Solutions For Research And Process Development
- Reducing Risk During CAR T Cell Therapy Development And Manufacture
- Former FDA Chief Talks COVID-19 Vaccine Future At Process Progress
- Peptones: Established Supplements For Vaccine Applications
- Understanding Perfusion Terminology
- Looking Back And Moving Forward In The Fight Against SARS-CoV-2
- Biosimilars: Evolving Challenges And Considerations
- Upstream Considerations For Biosimilar Development
- Residual Host Cell DNA Quantitation: In-House Vs. Commercial
- Can You Afford Not To Outsource Buffer Preparation?