Interest Group

(Bio-)pharmaceutical companies / institutes with LOT-Release relevant questions, manufacturers of cell culture products for the GMP sector.

Description

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).

Method

Qualitative Real-Time PCR

Applied PCR System

In-house

DNA Extraction

Included

Process Control

Extraction and amplification control

Sample Volume / PCR

5 μl

Average Turnaround Time

Depending on validation scope about 14-30 days

Sensitivity of Method

Based on sample matrix

EP conformity

N/A

Validation

Comprehensive*.

Sample Requirements

Depending on validation scope

Order No.

Custom

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.