Active Pharmaceutical Ingredient (API) Testing:

1. Residual host cell impurity test on genomic DNA and cellular RNA

available either as Real-Time qPCR Limit Test or as Quantitative Assay according to the ICH Q2 R1 guideline for analytical procedures.

available for Escherichia coli, Pichia pastoris, Spodoptera frugiperda Sf9, CHO expression systems.

 

2. GMP biopharmaceutical production host MCB and WCB characterization

Accelero Bioanalytics analyzes your Master Cell Bank (MCB) and derived Working Cell Banks (WCB):

Transgene copy number Real-Time qPCR quantification in the host genome of eukaryotic expression systems like Pichia pastoris.

Plasmid copy number quantification in prokaryotic expression systems like Escherichia coli.

Pichia transgenic locus PCR mapping and sequencing, available for GS115 and KM71 derived expression strains.

RAPD analysis assay in Agilent´s 2100 Bioanalyzer

 

3. Cell-Based Medicinal Product (CBMP) quality control

All assays are developed and validated on our ViiA7 Dx qPCR 384well System, which provides superior assay sensitivity

over previous qPCR systems in combination with excellent accuracy and precision, both in inter- and intraday assays.

Full IQ/OQ/PQ GMP compliant qPCR system installation and maintenance are obligatory.

 

 

Last update of this site: 13-OCT-2016 by Christian Lange