Extracellular Vesicles (EVs) in Formulation Development, Pre-clinical and Clinical Stages

Dear Colleagues,

Extracellular vesicles (EVs) are a group of natural carriers that may have the capability delivered delivering active pharmaceutical ingredients (APIs) for better therapeutic results. EVs may help APIs bypass certain delivery barriers to improve drug concentration at the target site(s). Such strategies may also reduce systemic side effects and may allow for higher dosing for patients.

In this Special Issue, we are calling for manuscripts covering every possible step in a product cycle, starting from EV production and purification to final EV drug formulation as well as pre-clinical/clinical trials. We also encourage manuscripts to discuss potential regulatory affairs and quality assurance, as peer-reviewed articles are one critical source for regulatory agencies, such as the US FDA, to help their draft guidelines for the industry.

There are no restrictions as to which medical conditions can be discussed. Manuscripts must cover at least one of the following aspects to be eligible for this Special Issue:

• The production and purification of EVs without any APIs. The inclusion of in-process quality control and characterization tests as well as final tests is encouraged.
• Formulation processing development using EVs to deliver APIs. The inclusion of in-process testing to show the encapsulation/affiliation/conjugation of the APIs is encouraged as they are critical for future development.
• Formulation processing development using EVs to deliver APIs using cell line/animal models in pre-clinical stages to show significant improvements in drug delivery.
• Any clinical trials using EVs to deliver APIs at all stages.
• Regulatory affairs and quality assurance (RAQA) to discuss/help regulatory agencies provide guidance for the industry.
• Any other aspects that authors are interested in and willing to discuss in advance with the editorial team before drafting.

We are looking forward to receiving your manuscripts, and we appreciate your contributions.

Dr. Murali Mohan Yallapu
Dr. Hao Shi
Guest Editors

Manuscript Submission Information

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