GMP Manufacturing
At Helix Biotech, we are formulation experts, excelling in the GMP manufacturing of lipid nanoparticles (LNPs), liposomes, polymer nanoparticles and other nanoparticle-based drug delivery systems.
LNP Production Methodology
At Helix Biotech, we utilize proven Impinged Jet Mixing (IJM) technology for the efficient production of lipid nanoparticles (LNPs). This advanced mixing method is designed to meet the growing demands of GMP-compliant manufacturing, ensuring consistent, high-quality LNP formulations crucial for R&D and clinical production.​​​​
Why Impinged Jet Mixing?
IJM offers superior control over particle size, polydispersity, and encapsulation efficiency, making it ideal for producing LNPs used in gene therapies, RNA vaccines, and drug delivery systems. Unlike other methods, IJM creates a turbulent mixing environment, enabling rapid, homogenous nanoparticle formation at both small and large scales.
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Scalability: IJM seamlessly scales from R&D to full-scale GMP production without compromising product quality, ensuring efficient transition to clinical and commercial phases.
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Process Control: By precisely controlling flow rates and jet velocities, IJM allows for the fine-tuning of particle characteristics, meeting critical quality attributes (CQAs) and regulatory standards.
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Footprint: The Nova platform achieves higher throughput by utilizing larger, more powerful pumps and mixers, eliminating the need for parallelized manufacturing systems and bulky skids of equipment.
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LNP Expertise in GMP Manufacturing and Scale Up
Even during the screening stage, we have a pathway to scaling up your manufacturing. Our expertise is in designing manufacturing systems and in GMP manufacturing of drug products which helps us streamline your development process.
We will help you design the optimal system to increase output and keep reagent, analytical, and FTE costs at a minimum.
Drug Substance and Drug Product Characterization
Table 1. Specifications and Methods Used for mRNA Drug Substance
Specification | Method |
|---|---|
Osmolality | USP <785> |
dsRNA Impurity | HPLC, ELISA |
Endotoxin | USP <85> Kinetic Chromogenic LAL |
Capping Efficiency and poly (A) | IP-RP-HPLC, RP-HPLC |
pH | USP <791> |
Appearance | USP <790> |
Concentration | UV, Fragment Analyzer, HPLC |
Nucleic Acid Integrity | Fragment Analyzer |
Identity | RT-PCR |
Sequence | Sanger Sequencing |
Table 2. Specifications and Methods Used for mRNA Drug Product
Specification | Method |
|---|---|
Container Closure Integrity | USP <1207> |
Subvisible Particles | USP <787> |
Osmolality | USP <785> |
Appearance | USP <790> |
Endotoxin | USP <85> |
Product Related Impurities - % of fragment mRNA | IP-RP-HPLC |
Product Related Impurities - aggregate quantitation | SEC-HPLC |
RNA Size and Integrity | Fragment Analyzer |
LNP Size and PDI | DLS |
RNA Concentration/RNA Encapsulation Efficiency | Fluorescence-Based Assay |
Lipid Identity | RP-HPLC-CAD |
RNA Identification | Sanger Sequencing, RT-PCR |