WEBINARS AND VIDEOS

• What Is The DynaChrom™ Single-Use Chromatography System?

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

• Quality Roundtable: Optimizing Biologics Manufacturing Processes With Raw Materials

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

• Upstream To Downstream: A Comprehensive Approach To AAV Production

  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.

• Planning for Success: Supply Resiliency Strategies for Bench to Production

  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.

• The Technology Debate: Single-Use vs. Stainless Steel

  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.

• An Advanced Single-Use Solution for Downstream Bioprocessing

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

• Environmental Sustainability In Bioprocessing

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

• Mitigate Bioprocessing Limitations With A More Efficient And Sustainable Harvest Solution

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

• Overcoming mAbs Development Challenges

  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.

• 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.

• 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.

• 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.

• How To Avoid 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

• 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.

• 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.

• 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.

• 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.

• 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.

• Rapid Media And Feed Screening Options For Targeted CHO Clones

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

• Single-Use Centrifuge Cinematic

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

• The Future Of Microbial Manufacturing: Protein And Plasmid Production

  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.

• Accelerating Cell Culture ​Media Manufacturing: Rapid Prototyping To cGMP

  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.

• Delivering Process Robustness And Scalability In Single-Use Bioreactors

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

• Thermo Fisher Scientific Singapore Single-Use Site Capacity Expansion

  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.

• Modularized Design Strategy Simplifies Biomanufacturing Processes

  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.

• Thermo Fisher Scientific Single-Use Global Manufacturing Network

  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.

• How To Fill And Empty Nunc Standard Closed Cell Factory System

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

• How To Fill And Empty Nunc Standard Cell Factory System

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

• Single-Use Global Manufacturing Network

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

• Nunc Standard Closed Cell Factory System

  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 Single-Use Chromatography System

  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.

• 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.

• 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.

• 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. 

• 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.

• 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.

• CentriPAK BioProcess Container Instructional Video

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

• CentriPAK BioProcess Container For Cell Culture Separations

  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 EMEA Single-Use Technologies Capacity Expansion

  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 China Single-Use Technologies Capacity Expansion

  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 North America Single-Use Technologies Capacity Expansion

  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.

• imPULSE Single-Use Mixer Video Animation

  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.

• 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.

• Cytovance Customer Testimonial: Thermo Scientific Single-Use Technologies

  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.

• Accelerating Delivery In The Next Stage Of The SARS-CoV-2 Battle

  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?

• Thermo Fisher Scientific Single-Use Technologies Capacity Expansion

  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.

• Optimizing Cell Culture Media Design: A Diverse Panel Reduces Uncertainty

  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.  

• Bioprocess Automation And Data Management Solutions

  We offer a portfolio of Thermo Scientific bioprocess equipment and automation solutions that are designed to reduce the complexity involved in scale-up and technology transfer, and enable the data management that is required of GMP-certified facilities for product quality, system validation, and record-keeping. We help you establish, transfer, and maintain recipes, alerts, batch records, and historian data with a consistent user interface from R&D to process development to GMP manufacturing.

• BioProcess Container (BPC) unpacking and installation Part 2

  This video is part 2 of 2 videos that cover the unpacking and inspection of Thermo Scientific BioProcess Containers (BPCs), including both 2D and 3D BPCs, manifolds, and tubing assemblies. In this video we will cover unboxing, inspecting, product support.

• BioProcess Container (BPC) unpacking and installation Part 1

  This video is part 1 of 2 videos that cover the unpacking and inspection of Thermo Scientific BioProcess Containers (BPCs), including both 2D and 3D BPCs, manifolds, and tubing assemblies. In this video we will cover packaging, components, initial setup.