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Join us for this Ask the Expert series of technical presentations from Repligen that will explore the benefit of introducing innovative technologies into your upstream and downstream bioprocessing workflows. These new solutions will help you to achieve increased performance and capacity, simplified processes, and improved product quality, while reducing operational costs from cell culture to final fill and finish.
Innovation in Tangential Flow Filtration:
Holder-Less Self-Contained Flat Sheet Cassette Device
| Date: November 30, 2023 | Time: 8 am PST | 11 am EST | 5 pm CET |
| Duration: 15 minutes |
Tangential Flow Filtration (TFF) has been a cornerstone technology in bioprocessing, enabling the separation and concentration of biomolecules with precision and efficiency. In this study, we introduce a groundbreaking innovation in TFF technology with the launch of the first holder-less self-contained true flat sheet cassette device. This device represents a paradigm shift in TFF, eliminating the need for traditional cassettes holders while delivering performance comparable to conventional formats. In this webinar, Repligen presents the TangenX SC Device, discuss benefits of a holder-less TFF process, and demonstrate comparability to traditional TFF cassettes while processing a crude monoclonal antibody (MAb) feed.
The introduction of the holder-less self-contained true flat sheet TFF device represents a significant advancement in TFF technology. Its versatility across bioprocessing applications and 80% reduction in process set up time opens new possibilities for simplifying and optimizing biomolecule manufacturing processes while maintaining product quality and yield.
Key Takeaways:
- The novel TFF device introduces a holder-less design, simplifying the setup and reducing the risk of cassette installation issues, thereby improving process efficiency and reliability.
- Easily scale from other cassette formats because the same channel path length is maintained across cassette formats with the same pressure drop profile from feed to retentate.
- The device incorporates a true flat sheet cassette design, ensuring uniform flow distribution across the membrane surface, resulting in consistent performance and enhanced product recovery.
- Testing reveals that the holder-less device delivers comparable performance to traditional cassette formats, achieving equivalent separation efficiency, flux rates, and fouling resistance.
- To validate the device's capabilities, we demonstrate its performance using both bovine IgG and a crude MAb feed stream. The device consistently achieves comparable recovery while effectively concentrating and diafiltering, demonstrating its suitability for critical bioprocessing applications.
Presenter:
Advantages of the XCell® ATF System for Upstream Process Intensification
| Date: December 5, 2023 | Time: 8 am PST | 11 am EST | 5 pm CET |
| Duration: 15 minutes |
With the constant pressure of meeting aggressive process development timelines while continuously improving upstream cell culture yield and productivity, developing the optimal processes from the beginning is crucial. With over 500 adoptions at process and commercial scale across biopharma globally, the XCell® ATF System is a proven technology for intensified cell culture that exponentially boosts productivity, lowers costs, and expands capacity of existing manufacturing facilities in upstream bioprocessing.
In this webinar, learn how the XCell® ATF System with its innovative Alternating Tangential Flow (ATF) technology unlocks up to 10x higher viable cell density (VCD) in half the time and up to 20x increase in productivity compared to traditional fed-batch processes, effectively reducing your cost of goods.
Repligen speaker, Muhammad Shamim will discuss real-world examples of how the system addresses challenges from lab to commercial scales. Register to get an in-depth look at the features and benefits of the recently introduced XCell® LS Controller, designed for integrated process control, seamless scalability, and enhanced productivity.
Key Takeaways:
- Discover how the XCell® ATF System achieves 10x higher MAb titers compared to traditional fed-batch processes.
- Gain insight on how the XCell® LS Controller enhances process control, productivity, scalability, and automation.
- Explore how leading biopharmas leverage XCell® ATF technology to accelerate timelines and expand facility capacity.
- Understand how Repligen's field applications team can guide your implementation, scale-up, and long-term success with XCell® ATF Systems.
Presenter:
Highlighting Stem Cell-Derived Exosomes Manufacturing Process
| Date: December 7, 2023 | Time: 8 am PST | 11 am EST | 5 pm CET |
| Duration: 30 minutes |
The number of clinical trials investigating viral vectors and MSC-EVs as therapeutic and skincare agents has been increasing greatly over the years. The complexity and fragility of the vector-based products, scalability, yield, and purity of production processes are challenges to meeting demand. With this comes the requirement to ensure that there are robust manufacturing processes in place to scale with demand and to make these therapies readily accessible to those who need them.
However, current manufacturing processes for vectors and exosomes have often been developed with limited scalability in mind and large shifts in technology must take place to enable industrialization. To overcome this challenge, we are presenting industrialization of an MSC-EVs case study which illustrates the next generation manufacturing process for large volume upstream manufacturing using high-quality hMSCs along with paired bioprocess medium formulations for cell growth and EV production and downstream clarification using tangential flow depth filtration (TFDF) system and highly efficient exosome concentration using tangential flow filtration (TFF) with hollow fibers. Parameters identified during the development phase of this study can be scalable to 2000 L bioreactor. For this case study, we will show the benefits of integrated manufacturing platforms for high-productivity and cost-effective exosome manufacturing to meet the increasing global demand.
Key Takeaways:
- Understanding industrial solutions for manufacturing of functional hMSC exosomes using scalable and low shear technologies that enable cost-effective commercialization of these advanced therapies.
- Learning how high recovery yields of potent EV was achieved at small-scale and large-scale cGMP compatible production.
- Analyzing how the EV downstream clarification and concentration process steps using the KrosFlo® TDFD® and KR2i with hollow fibers demonstrated high recovery and simplified the downstream process.
- Demonstrating the impact of integrated automated single-use high flux platforms on process time at scale of fully functional exosomes.
Presenters:
Elie Zakhem is the senior manager of process development at RoosterBio. In his current role, Elie leads the efforts to develop scalable processes for manufacturing MSCs and MSC-derived extracellular vesicles including the tech transfer part. Prior to joining RoosterBio, Elie was a senior scientist at ACell (now Integra LifeSciences) where his work focused on developing, optimizing, and characterizing extracellular matrix-based materials for regenerative medicine purposes. Elie graduated with a doctoral degree in molecular medicine and translational sciences from Wake Forest University with a focus on tissue engineering. He also has a master’s degree in biomedical engineering from Wayne State University. Elie has over 12 years of experience in the field of regenerative medicine
Jeremy Neidert performed this work and supported RoosterBio as a field application scientist with Repligen. After completing his bachelor's degree in biomedical engineering from Widener University, Jeremy began his career in biopharmaceutical processing at GSK where he worked in process development and large scale GMP manufacturing. He then moved to Ajinomoto, a CDMO, where he continued to focus on tech transfer and commercial manufacturing processes. This experience allows Jeremy to successfully assist and guide many customers to develop and implement upstream and downstream bioprocesses across a range of applications as a field application scientist at Repligen Corporation.
Tulip Tank Case Study:
The Unrecognized Role of Mixing During TFF
| Date: December 12, 2023 | Time: 8 am PST | 11 am EST | 5 pm CET |
| Duration: 30 minutes |
The degree of homogeneity in the feed that is delivered to the filters is a critical, but often overlooked factor. Even small changes in the nature of the feed will drastically impact performance, resulting in deviations during diafiltration.
This case study explores the impact of mixing dynamics on TFF performance. An innovative single-use Tulip Tank paired with the KrosFlo® RS 30 TFF system significantly improved performance as compared to traditional retentate vessels, reducing the gap between theoretical models and actual outcome.
Key Takeaways:
- Gain insight into feed inconsistencies and membrane performance in TFF.
- Understand benefits of good mixing to your production.
- Analyze vessel mixing methods.
- Examine mixing performance of conventional mixing vessels.
- Compare mixing performance: traditional vessels vs. Repligen’s RS TFF system.
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