Chemical Synthesis



Chemistry Department is responsible for developing active substancetechnologies for generic drugs both in the laboratory and large laboratory scale. It also conducts research on new substance of potential therapeutic value. The department is actively involved in the preparation of documents that are compliant with the European norms and allow to subsequently upscale the processes of API manufacturing even to the pilot plant scale.


Research carried out in the Chemistry Department includes synthesis method design and validation, followed by the active substance manufacture in the scale ranging up from milligrams to several grams of the final product (equipment capacity up to 10 L). Our researchers have certified experience in using various synthesis techniques, conducting processes in specific reaction conditions (anhydrous, anaerobic, in low temperatures, under pressure), as well as performing parallel syntheses and factor analyses for the reaction optimization. Development of the optimal crystallization conditions constitutes an integral part of the department’s activities and the research results are used in the polymorphism studies and product purification to the APIpurity. Separation techniques are also widely employed, including preparative high performance liquid chromatography (HPLC), as areother extraction techniques and methods for the substance preparation, e.g. freeze-drying.


Apart from the standard minor laboratory equipment, the technical resources of the Chemistry Department include, among others: vacuum evaporators, a 10 litre glass reactor with the instrumentation, a preparative HPLC system, a freeze-dryer, a hydrogen generator, vacuum driers, parallel reaction sets, etc.


Research offer:

Works carried out in the Chemistry Departmentinvolve full technology development in the laboratory scale and include, among other things:

  • literature and patent analysis
  • rational synthesis planning
  • polymorphic studies and new crystal formsproduction
  • substance synthesis development and optimization of its subsequent stages
  • substance technology development in the scale up to several hundred grams
  • preparing substance samples of pharmaceutical purity
  • impurity standards synthesis
  • documentation development

Personnel:

10 chemists, including:
1 person holding a professorial degree
7 employees with a doctoral degree


Chosen publications


Head:Marcin Cybulski, Ph.D.
Land line:(+48 22) 456 39 40
Mobile:(+48) 603 403 321
E-mail: m.cybulski@ifarm.eu