The company's technology platform is based on a microfluidic technology with improved characteristics and possibilities. Microfluidics is known to produce 100% encapsulation of an active substance by means of a one-step process and enables easy manipulation of individual droplets and precise control of their properties. The company has developed this microfluidic-based technology which allows development of highly uniform particles, both in size, morphology and drug loading. The particles are to be used as microcarriers for a specific drug to be delivered at the right place and the right time.
Currently, in the formulation phase of drug delivery system development, researchers orchestrate multiple parameters to create the desired product. Today's conventional technology however lacks good control over particle formation and they yield poor batch to batch consistency. Consequently, the results are easily biased and modification in the input parameters cannot be directly linked to a change in the end result. Ultimately, the current available parameter screening processes are often inaccurate, costly, and needlessly time-consuming.
The company's technology allows rapid screening of various parameters in order to create the optimal formulation for the pharmaceutical and biotechnology industry. Particles are formed individually in separate channels. This ensures uniformity of the sample in size, morphology and loading. The excellent control allows for modifying individual parameters while leaving others unchanged. The result is that various samples can be made with changes in the end result directly linked to individual parameter changes.
The R&D tool is very cost efficient, both in development and commercial production. During parameter screening the company uses a single channel and produces microgram volumes of dry material. As a result only a little of the expensive compound is needed to obtain results. Since the total volume of compound is also fully encapsulated, no API (Active Pharmaceutical Ingredient) is wasted in development and, more importantly, in full scale production.
Trial time can also be greatly reduced, because the company produces the particles directly on specifications. Little to no work-up is needed and various formulations can be rapidly scanned to prevent unnecessary risks in succeeding phases of the development pipeline.
Scale-up is recognized as one of the reasons for failure in many clinical trials and, frequently, it is the cause of great delay. Delay in development results in postponing product market entry and missing out on exclusive commercialization time. The Dutch SME is able to quickly increase the production facility while maintaining high reproducibility through a parallel scale-up process.
The offered technology allows for rapid prototyping. Many different formulations can be tested and the pharmaceutical and biotechnology industry is able to conduct more efficient research and avoid unnecessary failure. The R&D tool is also an enabling technology. Fragile compounds can easily be processed, without being deactivated. This way the pipeline can be filled up with many challenging but highly potent APIs.
Innovative Aspects:
The offered technology provides the following advantages for a regular drug delivery system production process:
- Suitable for processing fragile proteins and peptides
- Closed system process (inherent aseptic and oxygen-free conditions)
- Saving of ingredients
- Continuous production (switch to batch possible)
- No use of chemicals (emulsifiers, stabilizers, etc.)
- Process integration (no work-up needed, modular approach for the addition of process functions)
- High batch to batch consistency
- More consistent test results because of highly uniform particles
- Controlled release of poorly soluble compounds
- Improved bioavailability and low toxicity of active pharmaceutical ingredients.
