Alexander Aust, MS, MBA on LinkedIn: Commercially Available LNP Manufacturing Equipment

Lipid Nanoparticle Consultant, Strategic Operations Leader, & Aseptic Manufacturing Expert

2mo

Here is an up-to-date list of the Commercially Available Lipid Nanoparticle (LNP) Manufacturing Equipment that is out there right now. "There are a lot of new ways to manufacture nanoparticles at the development and cGMP scales that did not exist prior to the COVID-19 pandemic. For example, Table 1 shows the results of a survey of the commercial nanoparticle manufacturing equipment market from April 2024. There are Critical Process Parameters (CPPs) associated with the control of each of these systems. Understanding their impact on the quality and efficacy of the drug substance/drug product will need to be fully defined when progressing through the development and scale-up cycles, especially when switching from one ‘technology type’ to another. Thus, it is particularly important to understand the technical and regulatory support that each equipment vendor is willing to provide when you select their manufacturing equipment to formulate your RNA-LNP. This information will need to be documented in the CMC section of your submission." https://lnkd.in/e2vreRzq #Technology #Innovation #BestAdvice #BusinessIntelligence #LNP #DDS #PharmaceuticalManufacturing #Biotechnology #DrugsPharmaceuticals #Research #GMP #cGMP #FDA #EMA #NMPA #Nanoparticles #Nanotechnology #CellTherapy #GeneTherapy

14 Comments

Juha Mönkäre

Senior Scientist, Formulation, Drug Product Development, CMC, Gene&Cell Therapy

2mo

Thanks for sharing this! Do you think that there are enough markets for all these equipment in the long-term?

2 Reactions

Philipp Beck

Gene therapy formulation specialist: AAV + mRNA/LNP. Nanoparticle Nerd.

2mo

This list is my go-to choice to mute all the marketing noise - clear and concise. Thanks for curating this Alexander, it’s really helpful. #mRNA #LNP

6 Reactions

Marc Richter

Account Manager Biologics and Gene therapy, Exosome and Virus characterization at Unchained Labs

2mo

Hi Alexander, many thanks for generating the list of available LNP manufacturing equipment. Unchained labs has recently launched a new GMP-ready LNP production system - Sunbather https://www.unchainedlabs.com/sunbather/

2 Reactions

Robin Oliveres

Co-founder & CBO @InsideTx | Nanoparticle/RNA-LNP formulation and microfluidics expert | 50+inovative nanoparticles formulation systems provided: Eli Lilly, Servier, ETHZ, UCL, Moderna, Ribopro

2mo

Thanks again for this great piece of work Alex and for shining a light on Inside Tx’s LNP manufacturing equipment . This highly help advancing our mission to democratize microfluidics for nanoparticle formulation, making it more accesible, affordable and user-friendly!