Microfluidics International Corporation was proud to have Steve Mesite, Director Microfluidics Machines, selected to present at the ECCPM FORUM 2023. The European Consortium for Continuous Pharmaceutical Manufacturing FORUM was held September 13-14 in Graz, Austria and addressed Novel Approaches for Advanced Manufacturing.
The ECCPM FORUM 2023 was a 2-day event that combined intense scientific training with a curated panel of experts to facilitate the implementation of novel pharmaceutical manufacturing technologies. This elite event hosted international experts from pharmaceutical companies to governmental agencies, contract manufacturing organizations and to other various professionals in service and manufacturing fields to discuss the future of pharmaceutical production.
Steve provided insight into addressing how "Scalable Technology Helps Overcome Pharmaceutical Challenges." His highly engaged presentation focused on the development of a continuous, solvent-free, top-down production line of manufacturing of lipid-based nanoparticles using the scalable Microfluidizer® technology.
The Impact of Nanoparticles
Nanoparticles have made major impacts on the pharmaceutical industry. Nanoparticles are promising drug delivery platforms due to their enhanced targeted delivery efficiency, increased bioavailability, increased bio efficacy and controlled release capability. They are also desired antigen carriers and advanced novel adjuvants that enable the development of new generation therapies and vaccines. During the recent global pandemic, the record speed development of novel nucleic acid-based vaccines presented a prime example of lipid nanoparticles' (LNPs) critical role in encapsulating, protecting and delivering the messenger RNA (mRNA) payload.
The Challenges of Nanomaterials as Delivery Systems
However, despite the many advantages of using nanomaterials as delivery systems, the pharmaceutical industry is still faced with major manufacturing challenges, such as:
- Precisely controlled particle size/size distributions
- Process scalability
- Repeatability
- Regulatory requirement compliance
The COVID pandemic reemphasized the significant importance of how manufacturing process scale-up, from development to production, must allow for fast responses to address time critical situations. In this situation, a novel scalable technology was presented, and its advantages were demonstrated through several impactful case studies.
- The first case study, Technology for scalable production of lipid nanoparticles, showcased Microfluidizer® technology's use to produce various LNP formulations which mimic currently authorized mRNA vaccines.
- The second case study demonstrated the advantage in scalability of the Microfluidizer® technology in which the goal was to scale up the manufacturing of vaccine adjuvant nanoemulsion from several thousand doses to millions of doses per day. Many current methods of small-scale process cannot meet the demand and therefore, process improvements, especially the critical emulsification step, were necessary prior to a full scale-up. The proven scalability of the Microfluidizer® technology, along with re-engineering some of the production process, led to more than 25-fold increase in manufacturing efficiency. A batch equivalent to 5M doses can be produced in a small GMP manufacturing facility in just one day.
As part of the Nano Manufacturing and Biologistics segment, Dr. Ramona Jeitler, also provided insight into the Development of a Continuous In-line Monitored Lab Plant for the Nanoparticle Production Based on the Microfluidizer® Technology. As a Sr. Scientist at the University of Graz and Research Center of Phamaceutic Engineering (RCPE), Dr. Jeitler is an experienced lecturer and provided a wealth of knowledge regarding challenges of nanoparticle manufacturing.
In summary, Microfluidizer® technology has been proven to be a very efficient and reliable technology and is well-suited for manufacturing nano-materials for the pharmaceutical industry.
If you are interested in learning more about this presentation, our team will be happy to hear from you.
