Nanomedicine

Customer benefits

• Cost and time savings,

• Faster time-to-market,

• Flexible production quantities ("on demand"), i.e., no stockpiling of excess production,

• Innovation advantage
  

Research & Development Services

• Scalable mRNA formulation system for screening and process development

• Process development for continuous manufacturing of micromixer assisted nanocarriers

• Versatile nanoparticle systems for therapeutic and diagnostic applications

• Optimization and implementation of (inline) nano- and bioanalytics

In which volume range can we produce?

We have micromixing modules for various development stages from screening to production scale (1 mL to 100 L) without parallelisation.

What are the advantages of a modular continuous process?

A modular continuous process in nanoformulation enhances productivity, quality, scalability and reproducibility, making the process cost-effective. Further, it reduces the risk of contamination and human error by reducing the number of manual intervention, and enables innovation. From an advanced manufacturing aspect modular continuous processes can integrate advanced technologies such as real-time analytics, automation, and process optimization tools, driving innovation in nanoformulation.

How do we ensure reproducibility in the production of nanoformulations?

Continuous processes ensure consistent mixing and reaction conditions, resulting in more uniform and high-quality nanoparticles. Further advanced monitoring and control systems in modular setups allow for precise control of process parameters, leading to improved reproducibility and reliability of the nanoformulations.

How can we ensure scalability without changing the flow profile?

To ensure scalability without altering the flow profile of nanoformulation, maintain consistent process parameters (e.g., temperature, pH, mixing speed), use scalable equipment, and conduct thorough scale-up studies. Implement Process Analytical Technology (PAT) for real-time monitoring and control, and utilize computational fluid dynamics (CFD) for predictive modeling. Apply Quality by Design (QbD) principles to create a robust process within a defined design space, ensure stringent quality control of raw materials, and validate and continuously monitor the scaled-up process to ensure consistency in flow profile and product quality.

Which analytical methods are required for a comprehensive overall picture of the quality of nanotherapeutics?

To comprehensively analyse the quality of nanoformulations, the determination of their size and size distribution is crucial. For this purpose, we use dynamic light scattering as a standard method or utilise cryogenic transmission electron microscopy for further structural elucidation. With the help of our flowDLS for dynamic light scattering, the size can be continuously determined during production. Encapsulation efficiency is a further component of quality control and is determined by us using liquid chromatography, coupled mass spectroscopy or other chromatographic methods.

In which concentration and size range can the flowDLS measure and how representative are the measurements?

Depending on the measuring cell, the flowDLS can measure sizes between 5 and 230 nm. The flow rate can be selected up to 200 ml/min, which corresponds to very fast production conditions. Concentrations between 50 - 1500 mg/L can be measured without influencing the measurement result.