Contacts

Quality Control

MolMed GMP Solutions is able to provide a complete panel of analysis for product characterisation. 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 for both safety and stability studies and for cell characterisation tests.

Safety studies include sterility and bioburden testing according to the European and American Pharmacopoeia (EP and USP), endotoxin determination using qualitative and quantitative assays according to EP and USP, in vitro detection of adventitious viruses in cell cultures, and of viral vectors before and after purification. Other studies include determination of Replication-Competent Retroviruses (RCR) by cell and molecular assays and the Replication-Competent Lentiviruses (RCL) by cell assays, in addition to and mycoplasma detection tests using PCR.

Characterisation tests performed in our laboratories include cell viability assessed by manual and automated systems, transduction efficiency mediated by retroviral and lentiviral vectors, biological assays based on cell cultures such as cytokine-stimulated growth, drug resistance, functionality and cytotoxicity.
Other tests include qualitative and quantitative PCR and RT-PCR for DNA and RNA target sequences, vector integration and integrity by Southern Blot, SDS-PAGE quantification using BCA Protein, pH and morphology testing in accordance with the European Pharmacopoeia Size Exclusion Chromatography (SEC) using FPLC, Flow cytometry and Viral titration.

MolMed S.p.A. Via Olgettina, 58 - 20132 Milano, Italy | Phone +39 0221277.1 - Fax +39 02 21277.325 | info@molmed.com - www.molmed.com
Share capital € 20,949,084.36 fully paid - Office of Milan Company Registry number 1506630 - Tax identification number 11887610159