- How to reduce product loss and improve process viability in your cold chain management
- Improving scalability at large volumes
- Advantages of an end-to-end fully qualified platform approach in cold chain management

- How to identify key development and manufacturing challenges
- Commercial scalability strategies for late-stage cell therapies
- Ways to drive innovation to accelerate the delivery of cell therapies to patients faster
- How, when and why to leverage state-of-the-art facilities
- The importance of end-to-end supply chain management

- Adeno-associated virus (AAV) is go-to vector for gene therapy treatments. In each AAV downstream process, one of the key and often a bottleneck step is enrichment of full capsids. Along with scalability and capsid’s separation challenges one must account for sample heterogeneity and asses which analytics are adequate to distinguish between AAV sub-populations to deliver only the potent AAV product.
- Chromatography on monolith columns offers efficient and scalable downstream processes. Case study using Design-of-experiment approach of buffer selection and robust preparation for improved separation of empty and full capsids will be presented along with paramount considerations for scaling up. In addition, residual host cell proteins, host cell DNA, plasmid DNA, and endotoxin removal efficiency will be discussed.

- Meet the CellCelector™ system, a new clone-selection technology.
- Apply ML methods and regression models using MVDA.
- Simplify the deployment of complex data analytics using SIMCA.

- Integrating digital tools into research and process development can help reduce time to market. For example, simulation software provides fast and cost-effective means to test new parameters and forecast performance for various cell culture modalities. Moreover, investigators save valuable time using hybrid modeling to understand how process parameter adjustments impact cell growth, metabolism, and productivity.
- In this GEN webinar, our presenter will introduce an array of hybrid methods, including a mix of data-driven and mechanistic models. In addition, this presentation will outline several case studies to describe some applications of Cell Insights by Umetrics® Studio—an advanced data analytics application that expands on in-vitro experiments with in-silico simulations in a virtual bioreactor. These include identifying cell lines best suited for intensification strategies, optimizing process conditions to maximize productivity, and predicting the effects of media exchange to evaluate intensification and continuous perfusion strategies digitally.

- Screen and optimize your media, transfection reagents, and cell lines 
- Optimize your Critical Process Parameters (CPPs) with scaled-down models 
- Create your design space using Design of Experiment (DoE) methodology