Pharma
BIOPHARMACEUTICAL SERVICES
In GMP compliant biosafety level 3 facilities Chelab Pharma division provides analytical controls on immunological medicinal products, GMO medicinal products, advanced therapy medicinal products, medical devices manufactured utilyzing tissues of animal origin, biotechnology products and biological active starting materials.
Services
- Virus validation study to demonstrate the removal and/or inactivation of virus or other infectious agents
- Analytical controls on immunological medicinal products and blood and plasma derivatives for the manufacturer batch release, prior to the Official Control Authority batch release procedure provided by the EU legislation in force
- Analytical controls on biotechnology products and biological active raw materials
- Detection of human enteroviruses in water
- Evaluation of bactericidal, mycobactericidal, sporicidal, fungicidal, and virucidal activity of chemical disinfectans and antiseptics
- Tests for the validation of manufacturing and purifyng processes
- Evaluation of residues of antitumoral, cytostatic and cytotoxic agents
FOR TECHNICAL OR COMMERCIAL INFORMATION- 