QC TESTING

ABL maintains a robust in-house analytical function providing a wide range of product-specific and Compendial QC methods for viral vector and protein products.

ABL’s analytical services include methods development, transfer and optimization, qualification and full validation respective to the phase of clinical development; supporting QC release and stability testing according to ICH guidelines.

In-house QC testing capabilities include:

Product-Specific

Infectious titer (PFU, TCID50)
Viral genomes (qPCR, digital droplet PCR)
Genomic integrity & identity
Transgene expression
Functionality bioassays
HPLC titer
Identity (cells, virus, insert)
Genetic stability
Selective tumour cell killing
Western blot

Purity

Total protein
Host cell protein
Host cell DNA
Process related impurities (BSA, Benzonase, etc.)
SDS-PAGE
HPLC

Safety

Endotoxin
Bioburden

General / Physical

Appearance
pH
Osmolality
Extractable volume
Cell viability
Intact cells

Assays that require outsourcing are performed under ABL’s quality management system by approved vendors.