- The development of fast and efficient processes for the isolation of extracellular vesicles (EVs) depends on the availability of chromatography media that meet the special fractionation needs of these products and analytical methods for process monitoring. Convective Interaction Media (CIM®) monolithic columns offer high binding capacities and low shear stress conditions for the purification of large biologics such as EVs. Multiple-detector PATfix™ technology was developed for monitoring sample composition and product detection in upstream and downstream processes.
- We will present the EV isolation process from clarified conditioned media and fractionation using CIMmultus™ chromatography columns. Testing of the raw materials, analysis of upstream samples produced in different cell lines, and analysis of downstream samples were performed using PATfix™ analytical approaches. The composition of EV populations was monitored through the detection of tetraspanins using immunofluorescent labelling and SEC analytics. High-throughput analysis of in-process samples and impurity composition was monitored using CIMac™ anion exchange columns.

- Our CHO CLD platform was continuously improved over many years resulting in one of the leading technologies on the market
- Also, today dedicated teams of experts are working non-stop to further optimize the technology

- Learn about assay design and considerations in the development of lateral flow assays.
- Learn of the various applications of the Octet® label free systems for biomolecular interactions.
- Learn of how Octet® systems can be used as quality control platforms for the selection of optimal antibodies for the development of lateral flow assays.

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- Specific risk factors for implementing SU tools, as outlined in EP Annex 1
- How to form a regulatory strategy based on a quality risk management approach
- Requirements for SU system quality, sterility, E&L, integrity, and robustness

- How to mitigate ergonomic risks associated with the repetitive and physical demands of pipetting
- How to improve your results with ergonomic tools such as electronic pipettes
- How introducing liquid handling automation can streamline your pipetting procedures