Increasingly we are seeing customers that are looking for specialized formulation capabilities and, specifically, expertise in developing lipid nanoparticles. August Bio can work with a range of LNP formulation and sizing technologies to achieve the desired product profile.
Through thin-film deposition and rehydration or working with suppliers to develop custom jet mixing/solvent injection systems, we can design high-throughput processes that generate lipid nanoparticles for further processing. Downstream capabilities for high-shear mixing, high pressure homogenization and microfluidization can be configured to develop robust, reproducible manufacturing processes in R&D studies and then scaled to GMP for both clinical and commercial applications.
We couple this with analytical services ranging from dynamic light scattering for particle sizing, to LC/LC-MS/GC-FID/LC-CAD for lipid assays and residual solvent quantification. This allows August Bio to offer an end-to-end turn-key approach to product life cycle development starting at LNP process development and product characterization, moving through early GMP and eventually to commercial scale operations.
Most importantly, August Bio offers a dedicated team of development and technology transfer professionals with deep subject matter expertise that work as an extension of the sponsor’s team. The tools combined with the team allow for a reliable project schedule to be developed and maintained.