Chemical Analysis Department. Operations

The Chemical Analysis Department (ZACh) carries out various research and services. These include:

Research:

Research and studies are directly related to both, the subject areas and tasks executed by the Institute of Biotechnology and Antibiotics and by the external companies, which run scientific and implementation projects within the scope of drug development.
- Methods of research and studies on chemical and biotechnological substances as well as pharmaceutical and medicinal product formulations are developed;
- Research and studies on analytical control of technological processes, including the critical points, contamination profiles and process validation are conducted;
- Analytical research and studies of proteins at various stages of production of protein-origin active substances and medicinal products are designed. This includes: peptide mapping, proteolysis product analysis, development of new methods and analytical procedures for identification and quantitative determinations.

Services:

Services are provided in the field of chemical analyses and analytical research and studies. They include:
- analysis of medicinal products, active substances and chemical raw materials according to the normative documentation provided by a customer, suitable pharmacopoeias or in-house methods;
- validation of analytical methods;
- studies on the pharmaceutical availability of drugs;
- bioavailability and bioequivalence studies of drugs;
- studies on the stability of active substances and medicinal products;
- comprehensive analytical services for research projects related to the development of new medications: research and study method development, analytical method and
  manufacturing process validations, drafting of specifications,
  etc.