• Consultations on GMP operations
• Assistance with setting-up Collection and Tissue Establishments

• Sterility tests – by direct inoculation method in accordance with the latest Pharmacopoeia (art. 2.6.1 and 2.6.27); testing using Bact/ALERT equipment; providing relevant validations
• Cleanrooms monitoring – includes particles monitoring (equipment APC M3) and microbial monitoring (active – equipment Aeroscope MAS 110; passive – fallouts, imprints, smears)
• Phenotyping of the cells – flow cytometry (FACS), RT-PCR, etc.
• Mycoplasma testing – in accordance with the latest Pharmacopoeia (art. 2.6.7), by quantitative PCR

Contract manufacturing of ATMPs for clinical trials

• Production of validation batches
• IMPD preparation

• CRO services including monitoring and pharmacovigilance
• As contract partner (+ ATMPs manufacturing)

• Specific expression profiles of cells – RT-qPCR
• Testing of materials biocompatibility using various cell types (effects on viability, proliferation abilities, phenotype)
• Testing of antimicrobial effects of materials (including nanomaterials) on different types of bacteria, yeasts and fungi