Technical Capabilities

We focus on rapid optimization and material conservation during the initial discovery phase.

• Flat-Stock Membrane Extruders: A full range of Lypex bench extruders supporting various batch sizes for early feasibility studies.
• Benchtop Purification (TFF): Utilizing the Sartorius SartoSmart system for efficient, small-scale tangential flow filtration and buffer exchange.
• Thin-Film Hydration: High-precision Rotavap systems for consistent lipid film preparation.
• Probe Sonication: Specialized units for the rapid production of small-scale liposome batches.

Our facility bridges the gap between laboratory feasibility and commercial reality using proprietary, scalable processing technologies.

• Custom-Engineered Extrusion Systems: Utilizing specialized pleated cartridge membrane technology specifically designed for high-throughput processing.
• Proven Scalability: Our extrusion platform is validated for batches up to 20 kg, providing a seamless transition to future pilot-plant and commercial-scale production.
• Automated Purification: Integrated with the Sartorius Sartoflow (10 kg capacity) for high-efficiency Tangential Flow Filtration (TFF), ensuring consistent concentration and buffer exchange at scale.

We combine precision assembly with real-time analytical feedback to deliver high quality LNP formulations.

•  Microfluidic Self-Assembly: Controlled mixing using  the NanoAssemblr™ Ignite for batch sizes from 1 mL  to 20 mL.
• Integrated Quality Control: Every batch undergo immediate Particle Size and Zeta Potential analysis to confirm successful assembly and batch- to-batch consistency.
• Fluorescence-Based Validation: High-sensitivity assays to confirm mRNA encapsulation and payload integrity.

We provide rigorous physical and chemical validation for every formulation using industry-leading instrumentation.

• Zetasizer Pro: High-resolution DLS for particle size and Polydispersity Index (PDI).
• Malvern NanoSight NS300 (NTA): High-resolution size distribution and direct particle concentration.
• Zeta Potential: Surface charge and electrostatic stability via Zetasizer Pro.
• UHPLC-CAD/UV: Precise quantification of active payloads and non-chromophoric lipids.
• Fluorescence Assays: High-sensitivity mRNA encapsulation and loading efficiency validation.
• Microplate Readers: Tecan Spark® and Spectramax for high-throughput potency and binding assays.
• Thermal & Binding: MicroCal VP-DSC for phase transitions and ITC for molecular affinity.
• Wescor 5520: Measurement of Osmolality and pH for physiological compatibility.

This suite is dedicated to characterizing the physical stability, phase behavior, and molecular affinity of your lipid-based delivery systems.

• Differential Scanning Calorimetry (DSC): Utilizing the MicroCal VP-DSC to determine lipid phase transition temperatures (Tm) and assess the thermal stability of protein-conjugated formulations.
• Isothermal Titration Calorimetry (VP-ITC): Label-free, high-sensitivity binding studies to quantify the thermodynamics (affinity, stoichiometry, and enthalpy) of protein-LNP or ligand-receptor interactions.
• Multi-Mode Interaction Screening: Leveraging the Tecan Spark® Multimode and Spectramax readers for rapid, high-throughput fluorescence and UV-based binding assays.
• Stability Profiling: Real-time monitoring of structural integrity and aggregation tendencies under varying thermal stresses.

Our facility is equipped to transition liquid formulations into stable, cake-form drug products suitable for long-term storage and clinical distribution.

• Cycle Development & Optimization: Utilizing the Virtis Genesis 35EL to establish precise primary and secondary drying parameters for complex liposome and LNP formulations.
• Aseptic Processing: Integrated stoppering capabilities within the lyophilization chamber to maintain sterility and integrity for clinical-grade batches.
• Cake Characterization: Post-lyophilization analysis to ensure optimal moisture content, rapid reconstitution, and retention of particle size/PDI.
• Stability Studies: Accelerated and long-term storage testing to validate the shelf-life of your lyophilized drug product.