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Dear Readers, Welcome to the latest issue of The Magazine
In the past five years, messenger RNA (mRNA) therapeutics have presented new life-saving opportunities, going from experimental tools for medicine to effective mechanisms in producing vaccines and cancer therapy and producing therapeutic proteins on demand by instructing our own cells to produce proteins.
Yet, there are vivid engineering challenges behind this remarkable advancement. How do we deliver the weak mRNA safely and efficiently, and in a reproducible manner, to the cells? The best answer to this problem are lipid nanoparticles (LNPs) that have the capabilities of shielding lipid-based mRNA carriers protecting them from mRNA degradation, ensuring even cellular uptakes. That said, the traditional methods of LNPs have proven to be a bottleneck. The next advancement in LNPs are powered by microfluidic systems.
With no doubt, LNPs have proven to have great success in the mRNA discovery. Without them, the mRNA strands would still be unleaded. Their degradation would continue as mRNA therapeutics without potential for success. Their compositions are basic, as the required lipids must be balanced to allow for mRNA to have the needed potency and safety. small changes in the lipids can impact the biocompatibility and stability of the mRNA lipoconjugate.
Microfluidics allow for the manipulation of fluids in a precise manner. In LNPs formulations, it would permit the changes needed to make a potent and stable LNPs, as well as make it at large macroscopic volumes.
When it comes to LNP manufacturing, conventional bulk methods such as ethanol injection or layering vortexing result in batch inconsistencies and a lack of control over the particles’ size (2). To address this challenge, microfluidic systems function in a laminar regime, where diffusion and hydrodynamic focusing control assembly (3,4) .
These systems allow a fast, precise, and controlled mixing of the lipid and aqueous phases at predetermined flow rates and ratios. This degree of control sets microfluidics apart to optimize the process and to ensure reproducibility at industrial scales, with amplified control and scalability.
Schematic representation of mRNA–LNP synthesis via a microfluidic chip. mRNA (Pump 1) and lipid mix (Pump 2) are co-injected, forming mRNA-loaded LNPs. (b) Simplified microchannel geometry with two inlets and one outlet for nanoparticle collection.
When shifting microfluidic systems from the lab to manufacturing, key challenges arise—predominantly in scalability and process robustness paradox. To achieve therapeutic-scale output, the microfluidic systems would require a high number of parallel microfluidic channels, or the implementation of high-throughput systems. Balanced flow in all channels is important to ensure consistent particle size and reproducibility encapsulation.
Nonetheless, microfluidics is the only bulk mixing technology that provides such accuracy, enabling the formation of LNPs in more uniform distributions with scalable continuous-flow systems. Such systems are more efficient, as they reduce operational waste, downtime, and costs.
In the microfluidics ecosystem, automated platforms enhance R&D by providing quicker, low-volume optimization with clearer pathways to pilot-scale translation.
One such automated platform is the Nanomake-L™ system, engineered to produce nanoparticles reproducibly and with flow control.
Through the combination of fully independent precursor pumping, programmable flow, and reusable chips, it retains key parameters resulting in TFR and FRR, is compatible with mRNA–LNPs and other nano formulations, and achieves narrow size distributions with high encapsulation efficiency. This positions nanomake-L™ as the ideal candidate for bottom-up early formulation development and scale-up.
The importance of automated microfluidic platforms for LNP-mRNA synthesis in the context of domestic manufacturing and the adoption of new technologies cannot be overstated. The majority of microfluidic platforms on the market are incorporated as expensive imports, which do not integrate seamlessly into local bioproduction workflows and infrastructure. The development of local systems addresses these challenges by providing mRNA–LNP manufacturing solutions at an economically sustainable price, while also providing reliability. These systems will be pivotal in the continuity from researcher-grade systems to integrated pilot systems and controlled GMP workflows.
The expansion of mRNA therapeutics entail the need for accurate and scalable LNP manufacturing. Microfluidics provides the necessary control for production to be precise and consistent. With continual advancement in design and automation of the devices, it will likely be the go-to method for mRNA- LNP manufacturing.
Products like the nanomake-L™ is a testament to the capabilities of microfluidic engineering, turning scientific breakthroughs to commercially scalable manufacturing for the betterment of the pharmaceutical industry and accessibility to modern therapeutics.
Dr. Ganesh Gaikwad
Team Head Product Development
Amar Biosystems Email: [email protected]
