Particle engineering – a bridge from the active ingredient to the drug product
Jesalis Pharma develops special particle engineering technologies for active pharmaceutical ingredients from the lab-scale to the production scale
The main focus is:
1. Microcrystallization for active ingredients
- proprietary technological platform for continuous crystallization processes for the manufacture of pure and highly crystalline API-particles. The particle can be adapted to the requirements of the product. The Accessible size range is from around 500 nm to 50 µm.
- the high precision and reproducibility in the designed particle size, the narrow particle size distribution and the high crystallinity make our microcrystalline products a better alternative when compared to the conventional technologies, especially in the case of
- pulmonary applications
- low and ultra low dose forms
- APIs with low bioavailability and with problems in micronisation with conventional technologies
2. Micronisation of active ingredients
- feasibility on lab-scale and solid state evaluation
- manufacturing of samples for pharmaceutical development
3. Spray drying processes
- feasibility in lab-scale and solid state evaluation
- manufacturing of samples for pharmaceutical development
4. Preformulation technologies
- development of API-Excipient-Compounds to improve the processibility and bioavailability of the active ingredients, e.g. spray embedding and coating by spray drying technologies
- manufacturing of samples for pharmaceutical development
5. Purification technologies for API-s and intermediates
- chromatography
- conventional-batch and continuous counter current crystallization
Core competences and development strategies
- tailor-made problem analysis for our customers (e.g. dissolution problems, deviations in particle size, undesired instable forms, amorphisation and dehydration during milling processes, amongst others)
- rapid evaluation and solution suggestions for our customers, based upon suitable substance property and process data. On request, data can be determined with our powerful analytical tools.
- evaluation and decision concerning further project progress on the basis of feasibility studies together with our customers
- development of, preferentially continuous, processes and micro- and miniplant technologies (modelling, process design & scale up)
- analytics directly embedded in technology development
- consideration of requirements of pharmaceutical development such as GLP, GMP, QbD, PAT and intensive cooperation with the pharmaceutical developer
- cost sensitive