Solution
ExoPure
Exosome Purification Platform
ExoPure is an exosome purification and formulation platform that DrSignal Biotechnology has been developing since 2019. It brings together three units — tangential flow filtration, multimodal chromatography and aseptic filling — to complete a one-stop process from conditioned medium to finished product within a fully closed flow path. The platform has passed three-batch process validation at our own GMP facility, handles up to 200 liters per batch, and holds batch-to-batch variation in particle size distribution and marker protein expression to within 15%.
Tangential Flow Filtration
Continuous Tangential Flow Separation
Hollow-fiber membrane modules run continuous tangential flow filtration, performing concentration and diafiltration simultaneously within a single closed loop. Conditioned medium is reduced to 1/50 of its original volume, and more than 95% of free protein and residual medium is removed. Single-use consumables are used throughout, eliminating cross-contamination between batches.
Multimodal Chromatography
Multimodal Chromatography Polishing
Multimodal chromatography resins separate exosomes from same-sized impurities by differences in surface charge and hydrophobicity, sustaining a recovery rate above 70% with residual endotoxin below 0.5 EU/mL. Chromatography parameters are logged automatically by the process management system in compliance with electronic records requirements.
Manufacturing Process
From cell expansion to final release, the process runs through eight stages, all carried out in an ISO Class 7 cleanroom environment and within closed flow paths. The process management system records temperature, pressure and flow rate in real time, giving every batch full traceability.
Cell Expansion
Conditioned Medium Collection
Clarification Filtration
Tangential Flow Concentration
Multimodal Chromatography
Aseptic Filling
Quality Testing and Release
Cold Chain Delivery
Technical Advantages
Scalable Capacity of 200 Liters per Batch
The modular design can be expanded in parallel as required, processing up to 200 liters of conditioned medium per batch — roughly 20 times the throughput of laboratory scale.
Batch Consistency Within 15%
Nanoparticle tracking analysis and flow cytometry bead assays jointly monitor particle size distribution and CD9 / CD63 / CD81 marker expression. Across three validation batches, batch-to-batch variation stayed below 15%.
Fully Closed Single-Use Process
From clarification filtration through aseptic filling, the process runs on a fully closed single-use flow path. Cleaning validation is no longer required, and changeover time drops from 72 hours to 8 hours.
ExoPure Technical Specification
PDFCovers platform process parameters, quality specifications and a summary of three-batch validation data.