Bacterially derived extracellular vesicles (EVs) such as Outer Membrane Vesicles (OMVs) have emerged as an attractive new modality for both immunotherapy and as vectors for nucleotides and proteins.
Being a highly heterogenic biological, the translation from research to clinical use is not without challenges. Developing effective scalable manufacturing processes and qualified analytical methods meeting the CMC requirements of Good Manufacturing Practices (GMP) needs to follow a defined path.