ABOUT THERMO FISHER SCIENTIFIC

Thermo Fisher is a leading global provider of bioprocessing solutions.  We simplify the development path and accelerate our customers’ innovations to bring therapies to patients, faster. With our comprehensive portfolio of products and services we are a dedicated partner throughout the biological drug development journey.

Key Capabilities:

  • Media and buffer preparation
  • Cell expansion
  • Cell culture production
  • Harvest
  • Capture and polish chromatography
  • Viral inactivation, filtration, and QC testing
  • Bulk storage, fill, and finish
  • cGMP chemicals and supply chain services
  • Expert professional support to meet process, scale, quality, and regulatory requirements

WEBINARS AND VIDEOS

  • Choose the right CHO medium and feed system to optimize your upstream processes and secure a seamless scaling up.

  • Whether you are a researcher, scientist, or industry professional, this video will provide valuable insights into our large volume liquids manufacturing capabilities.

  • This video provides an insightful look into the expansion of the large volume liquids manufacturing site at the Grand Island facility, highlighting the various stages of the manufacturing process and the capabilities it offers to support the bioprocessing industry.

  • This chromatography system offers a flexible solution, paired with an advanced software platform, allowing easy integration with downstream process automation.

  • Improve your commercial manufacturing process with advice from regulatory and raw materials experts on the development journey from pre-clinical to licensure.

  • How can you face the challenges of AAV production, scale up your AAV manufacturing effectively, and enhance the recovery and purity in your downstream processing.

  • Build scalable material sourcing strategies for R&D and early phases through to commercialization and learn how to accelerate the development process and ensure the scalability of your biologics.

  • In this discussion you will explore the multi-point case for adopting single-use technologies throughout the workflow via an economic, operational, and environmental sustainability lens.

  • A single-use chromatography system is offering an innovative solution tailored to meet the needs of evolving downstream purification bioprocesses.

  • This conversation focuses on sustainability in bioprocessing and the exciting advancements happening in the space, featuring practical examples and case studies.

  • Subject matter experts in research and development, product management, and bioprocessing research introduce a single-use centrifuge, and its simplified, automated, intensified processing.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Explore efficient and effective ways to identify a formulation for your clone – helping you streamline your process and achieve desired results.

  • Gain a 360° view of the Thermo Scientific™ DynaSpin™ Single-Use Centrifuge.

  • Explore advances in the development of a one-part chemically defined microbial medium to simplify workflows and achieve high density cultures for recombinant protein or plasmid production applications.

  • Learn ways to decrease logistical roadblocks, increase quality, and simplify the journey from finalization of media performance to scale-up, including how media analytics help optimize prototyping formulation.

  • Learn more about understanding the process robustness and vessel capability’s role in a seamless system transfer and S.U.B. process comparability.

  • By expanding our single-use manufacturing network globally resulting in expanded capacity and shorter product lead times with consistent quality, and better load balancing support across our manufacturing network in the region.

  • We interview two SMEs that live the daily challenges imposed by a lack of modularization and standardization and a high degree of customization in their multiple tech transfer programs.

  • We have implemented a multi-tier strategy to improve the resiliency of our supply chain and created the largest networked single-use manufacturing organization in the world.

  • This video provides step by step how to instructions to fill and empty the Nunc Standard Closed Cell Factory System.

  • This video provides step by step how to instructions to fill and empty the Nunc Standard Cell Factory System.

  • We are committed to finding solutions to optimize the way we deliver single-use products to our customers around the globe.

  • This clean and closed system is designed to provide consistent and high-quality results to enhance your adherent cell culture processes. This ready-to-use system will help you quickly develop and scale up your processes with standard components for supply assurance.

  • A complete hardware, software, and single-use system that helps meet the demands of modern downstream bioprocessing with isocratic, gradient, and in-line dilution processing capability.

  • 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.

  • This video describes the easy three step process to use the CentriPAK BioProcess Container in your application.

  • This video highlights the Thermo Scientific CentriPAK BioProcess Container. This next generation centrifuge container provides a single-use, sterilized, closed system for cell culture separations.

  • Thermo Fisher Scientific is expanding our single-use manufacturing network globally. Our Cramlington, UK site has expanded clean room space and invested in chamber manufacturing equipment for our BioProcess Containers and fluid transfer assemblies. Quality systems and processes have also been harmonized with other single-use manufacturing sites to provide true manufacturing redundancy for our customers.

  • Thermo Fisher Scientific is expanding our single-use manufacturing network globally. With continuous growth in China’s population, we have seen an increase in demand for human therapeutics and vaccines and an even greater need for investment in public health and safety to develop biopharmaceutical products in China.

  • Thermo Fisher Scientific is expanding our single-use manufacturing network globally. Some of the largest investments are taking place at our existing Logan, Utah, and Millersburg, Pennsylvania, sites. We are adding space for clean rooms for the manufacturing and assembly of Thermo Scientific BioProcess Containers and fluid transfer assemblies, investing in 2D and 3D chamber manufacturing equipment, and harmonizing our quality systems and processes.

  • This video animation details the benefits of the Thermo Scientific imPULSE Single-Use Mixer and illustrates how to use these mixers in an upstream and downstream mixing application.

  • 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.

  • Thermo Fisher Scientific has served as a key partner in the bioprocess industry, by establishing manufacturing and development capabilities, enabling Cytovance Biologics to expand offerings their product offering, to better serve clients with diverse pharmaceutical needs. In this video, the imPULSE Single-Use Mixer is highlighted for protein refolding applications at a 30 L scale and then transferred to manufacturing operations up to 5,000 L scale.

  • 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?

  • Single-use technologies have been widely adopted in research and process development and are now the foundation for entire manufacturing suites. To meet the increased demand in the industry regarding quality expectations and product availability, Thermo Fisher Scientific is investing $120 million to expand their single-use technologies manufacturing network.

  • This on-demand webinar reviews best practices for selecting the optimal media for a specific cell line’s growth using a media panel approach to reduce timelines and increase productivity.  

CONTACT INFORMATION

Thermo Fisher Scientific

7305 Executive Way

Frederick, MD 21704

UNITED STATES

Contact: Hunter Tuck