(Bio-)pharmaceutical companies / institutes with LOT-Release relevant questions, manufacturers of cell culture products for the GMP sector.
Working with primary donor materials or release of cell-based biopharmaceutical products might require require human virus testing as determined on a risk based assessment. We offer validation of your virus testing specific to your matrix using appropriate viral standards (HIV1 / 2, Heptatis A / B / C, PB19). Minerva Analytix GmbH has the appropriate premises for method validation in viral qPCR assays in a GMP environment.
Recommended Sample Material
Cell culture supernatant, serum, plasma (different matrices on request).
Qualitative Real-Time PCR
Applied PCR System
Extraction and amplification control
Sample Volume / PCR
Average Turnaround Time
Depending on validation scope about 14-30 days
Sensitivity of Method
Based on sample matrix
Depending on validation scope
Volume Discount Available
yes, on request
*Please note, that a validated procedure is available for standard sample materials only. For any other materials an individual validation may be required to demonstrate the efficiency of the pre-analytical procedure in means of sensitivity. Please contact us for further information.