In contrast, exosomes derived from PSCs have the highest yield and the high rate of drug loading, while exosomes derived from macrophages have the strongest antitumor activity, indicating the specificity of exosomes from different sources. Regardless of their clinical indication, exosomes and their use must comply with good manufacturing practices (GMP). A GMP quality exosome production process includes materials, cells, culture environment, manufacturing technologies, and qualified labor of the highest quality for highly controlled and strictly monitored conditions. In addition, purification and release tests using quality control are essential after production to ensure that the final product meets the highest standards before being administered to patients for the intended use.
The European Medicines Agency and the United States Food and Drug Administration have organized workshops and recognize that new scientific advances in cellular and molecular biotechnology have led to the development of advanced therapies. Both agencies have also published recommendations and classifications for the production of advanced therapies. As the emerging field of exosomes continues to expand in the fields of therapy and diagnostics, researchers and manufacturers need to make more recommendations, guidelines and criteria to make advanced therapies safe for use by patients. Standard freeze-dried exosomes are easy to transport and store and are stable for more than 2 years at temperatures between 2 °C and 8 °C.
Immunostep provides the highest quality lyophilized exosome standards isolated from a variety of biological sources, including cell culture supernatant, human plasma, serum, urine and saliva. Exosomes are isolated by differential ultracentrifugation. Because platelets play such an important role in wound healing, collagen formation, and inflammation, platelets are the best source of exosomes for skin rejuvenation. Exosomes isolated from platelets have benefits similar to those of injectable PRP (platelet-rich plasma) treatments used to treat skin aging.
