Translating Exosome Candidates into Approved Therapies with engEx® Platform Technologies

Exosomes represent one type of extracellular vesicle (EV) generated by all eukaryotic cells. Exosomes are a new modality with tremendous potential to enable delivery of drug substances that are too toxic for free systemic administration, to what were previously thought to be undruggable targets. Early clinical data has revealed the potential efficacy and highlighted the safety of these natural delivery vehicles. Like other next-generation biologics, however, exosomes are complex, and their development and manufacture can be challenging. Therapy developers can now benefit greatly from Lonza’s engEx® technology, our experience and deep knowledge regarding exosome process development, optimization, manufacturing, and regulatory understanding gained through interactions with regulatory authorities.