Quality Control
MolMed GMP Solutions is able to provide a complete panel of analysis for products characterization. Our scientific knowledge in cell biology, immunology, microbiology and molecular biology allow us to meet the specific needs of our customers.
In our Quality Control unit, experienced technical staff and top level researchers can interpret, adapt and manage the service in accordance with GMP.
• Sterility test and bioburden according with the European and American Pharmacopoeia (USP & EP).
• Endotoxin determination using qualitative and quantitative assays according with the EP & UP.
• In vitro detection of adventitious viruses in cell cultures, and of viral vectors before and after purification.
• Determination of replication-competent retrovirus (RCR) by cultural and molecular assays.
• Determination of replication-competent lentivirus (RCL) by cultural assays.
• Test for the detection of Mycoplasma by PCR.
• Transduction efficiency mediated by retroviral and lentiviral vectors.
• Cell viability assessed by manual and automated systems.
• Biological assays based on cell cultures, to evaluate: growth stimulated by cytokines, drug resistance, functionality and cytotoxicity.
• Tests to analyze the ability of hematopoietic progenitor cell to form colonies (EP 2.7.28).
• Qualitative and quantitative PCR and RT-PCR for different DNA and RNA target sequences.
• Vector integration and integrity by Southern Blot.
• SDS-PAGE quantitation using BCA Protein, pH and appearance in accordance with the European Pharmacopoeia (EP).
• SEC (Size Exclusion Chromatography) using FPLC.
• Flow cytometry.
• Viral titrations.
ELISA ASSAY OF BIOLOGICAL FLUIDS
STABILITY STUDIES
