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.

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.

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.

Boehringer Ingelheim BioXcellence™ offers comprehensive support for successful development and manufacturing, treating customers' products as if they were their own. Their expertise spans both mammalian cell culture and microbial fermentation technologies. The microbial product landscape, a specialty market, demands a variety of manufacturing process formats to cater to different molecule formats.

Their unique strength lies in the combination of their extensive commercial expertise and development capabilities. This enables them to provide the complete value chain, from early stages to launch and commercial supplies, for microbial derived biopharmaceuticals.

Discover how they can help drive your biologic breakthroughs towards a healthier future.