WEBINARS AND VIDEOS

• The Role of Peptones In Enhancing Efficiency

  Discover how peptones enhance vaccine manufacturing efficiency with valuable insights into cost-effective solutions, variability control in biologically derived materials, and more.

• Outsourcing Considerations For Novel Protein Therapeutics

  Panelists discuss special considerations for outsourcing the development and manufacturing of novel, complex protein therapeutics in this Bioprocess Online Live event.

• Addressing Aggregation And Degradation In Complex Protein Therapeutics

  In this segment of the Bioprocess Online Live event Early Process Considerations For Novel Protein Therapeutics, panelists discuss using a transient expression platform to make fast early product attribute decisions.

• When To Conduct Analytical Assays In Novel Protein Therapeutic Development

  Panelists in the Bioprocess Online Live event discuss the various points at which analytical assays are most critical during complex protein therapeutic development.

• IND Prep Versus Clincal/Commercial Scale-Up In Novel Protein Therapeutics

  In this segment of the Bioprocess Online Live event Early Process Considerations For Novel Protein Therapeutics, panelists share detailed considerations for scale-up of complex protein therapeutics.

• Addressing Post-Translational Modifications In Novel Protein Therapeutics

  Meinhard Hasslacher, Ph.D., Head of CMC at SOTIO Biotech, addresses an audience question on conjugation efficiencies in this segment of the Bioprocess Online Live event Early Process Considerations For Novel Protein Therapeutics. From there, we move on to an audience-led discussion on when to initially address titer, PTMS, and product quality during development of novel protein therapeutic cell lines, with Lena Tholen, Ph.D, Director of Cell Line and Bioprocess Development at FyoniBio and Neeraj Pakala, Ph.D. SVP of Product Development and Manufacturing at Vera Therapeutics weighing in.

• Key Attributes To Monitor During Cell Line Development Of Complex Proteins

  In this segment of the Bioprocess Online Live event Early Process Considerations For Novel Protein Therapeutics, panelists discuss key attributes to monitor during cell line development processes.

• Cell Line Selection In Novel Protein Therapeutic Development

  Lena Tholen, Ph.D., and Meinhard Hasslacher, Ph.D., weigh in early on important cell line selection considerations for novel protein therapeutics in this segment of "Early Process Considerations For Novel Protein Therapeutics".

• Three Novel Protein Therapeutic Worldviews

  In this segment of the Bioprocess Online Live event Early Process Considerations For Novel Protein Therapeutics, we meet panelists who share their topline perspectives on developing complex, novel protein therapeutics.

• Maximize Quality Assurance Through Rapid Sterility Testing

  This webinar explores mitigating the risk of product loss, and production delays, as well as the critical role rapid sterility testing plays in ensuring the quality and safety of cell therapy products.

• What's Next For Bioprocess Intensification?

  Experts speaking on Bioprocess Intensification In The Real World wrap up the Bioprocess Online Live event with parting shots and reflections on the current state of process intensification and what the future holds.

• Considerations In Continuous Chromatography

  In this segment of the Bioprocess Online Live event Bioprocess Intensification In The Real World, our presenters discuss considerations for continuous versus batch chromatography and compare notes on the approaches at their respective organizations.

• What Analytics Drive Process Intensification?

  Bioprocess Online Live panelists discuss the most fundamental analytics that inform and enable process intensification strategies in this segment of Bioprocess Intensification In The Real World.

• Process Intensification Development Challenges At AZ and AbbVie

  In this segment of the Bioprocess Online Live event Bioprocess Intensification In The Real World, panelists respond to audience questions about the challenges they’ve encountered while developing process intensification strategies.

• Process Intensification Audience Q&A

  Our panelists take audience questions on process intensification lessons learned from other industries.

• Where Process Intensification Sits In The AbbVie, AstraZeneca Organizations

  In this segment of the Bioprocess Online Live event Bioprocess Intensification In The Real World, panelists discuss where and how their roles in setting the course for process intensification sit within their greater organizations.

• What Bioprocessing Bottlenecks Does Process Intensification Address?

  Supply chains, consumables, and data are identified as three of the management challenges that intensified processes and process automation technology (PAT) are addressing at AbbVie and AstraZeneca.

• Why AstraZeneca and AbbVie Are Intensifying Processes

  In this segment of the Bioprocess Online Live event Bioprocess Intensification In The Real World, our speakers share the motivation for continued process intensification in their respective organizations.

• Accelerating mAb Process Development In The Growing Therapeutics Market

  The market for mAbs and mAb variants is growing rapidly. Explore the latest strategies and advancements in early stage mAb up- and downstream process development.

• Scalable By Design: Streamlining Cell Culture Media Manufacturing

  Learn ways to help improve quality, simplify technology transfer of proprietary media formulations, and mitigate logistical challenges associated with custom media scale-up processes.

• Thermo Fisher Scientific Bio-Expo Live 2024: Downstream Bioprocessing

  Review downstream process tools from Thermo Fisher Scientific to enable optimal biologics purification, including chromatography resins, chemicals, process liquids, and buffers.

• Thermo Fisher Scientific Bio-Expo Live 2024: Upstream Bioprocessing: A Next-Gen Medium And Feed System

  This presentation reviews next-generation cell culture media and feed options and a recent successful scale-up case study done in collaboration with Centre for Biochemical Engineering and Cell Cultivation Techniques at the Zurich University of Applied Sciences.

• Accelerate Process Development With HTS Chromatography Tools

  High Throughput Screening (HTS) chromatography tools can accelerate process development and reduce material usage. However, their use is less common in some modalities due to sample restrictions and the need for HTS expertise.

• Next-Gen Medium And Feeds System To Improve CHO Cell Line Productivity

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

• Process Liquids And Buffers Offering

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

• Thermo Fisher Scientific Large Volume Liquid Expansion

  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.

• 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.