Technology Development

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