Dear Zijing,
Thank you for posting your questions. I think the questions that you are asking about are also being discussed in our upcoming webinars and I encourage you to take advantage of our past and upcoming webinars which cover a few of the topics you have asked about:
- Sept 23rd webinar when Dr. Pieter Cullis will discuss "Design of Lipid Nanoparticles to Enable Gene Therapies" ( register here)
- Oct 30th webinar on "Current State of Nanomedicine Drug Products: An Industry Perspective" by our industry speakers Dr. Patrick Lim Soo (Pfizer) and Dr. Geoffrey Clogstone from Leidos Biomedical Research/ Nanotechnology Characterization Lab Current state of nanomedicine registration
- Past webinar, Feb 11, 2025: We covered use of AI to screen and select novel lipids for tissue specific nucleic acid delivery in a webinar on 'Advances in in-vivo Therapeutic Nucleic Acid Delivery - Ushering a New Era". You can find the recording here: Link to recording
Regarding your second question, I refer you to a webinar that we at nanotechnology organized recently with Dr. Frank Szoka talking about "Liposomes- from the Laboratory to the Clinic". This talk was very insightful about what is required to translate novel lipid designs from preclinical research into clinically viable, industrially scalable therapeutics. You can find a recording of this webinar here: Webinar link
In general critical quality attributes (CQAs) of LNPs include lipid identity, content, purity, and integrity. Other important CQAs for the mRNA-LNP Drug Product (DP) include mRNA identity, content, purity, integrity and mRNA/lipid ratio. The CQAs of LNP-based DP also include potency, particle size, surface charge, sub-visible particles, particulate matter, osmolality, endotoxin levels and sterility. All of these CQAs should be assessed and the results should be within the required specification limits. For more information, I refer you to the guidelines established for liposome drug products [https://www.fda.gov/media/70837/download ], and biologic products [https://www.fda.gov/media/109910/download ] by the US Food and Drug Administration (FDA) and the United States Pharmacopeia (USP). There are also FDA and EMEA guidelines for mRNA vaccines that you could review.
Best regards,
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Mitra Mosharraf, PhD
Chair, AAPS Nanotechnology
HTD Biosystems, CSO
[email protected]Livermore, CA
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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Original Message:
Sent: 08-12-2025 09:59
From: Zijing Xu
Subject: Question Regarding the Advancement of Lipid Nanoparticle (LNP) Development
Hello Nanotechnology Community,
As a graduate trainee working on the development of novel lipid nanoparticle (LNP) formulations, I am eager to hear the perspectives of Nanotechnology Community members on the current advancements in LNP technology.
As LNP platforms progress toward organ- and cell-specific delivery, how are innovations in lipid chemistry being optimized to achieve precise targeting, robust formulation stability, and compatibility with large-scale manufacturing processes?
In addition, what do you see as the most critical scientific and engineering trade-offs that must be addressed to successfully translate novel lipid designs from preclinical research into clinically viable, industrially scalable therapeutics?
Thank you in advance for your insights!
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Zijing Xu
PhD Candidate/Graduate Assistant
University of Florida College of Pharmacy
Gainesville FL
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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