Quality Control

ABL Europe

ABL Europe has a particularly strong in-house analytical function providing a wide range of viral vector product specific QC methods in addition to generic pharmacopeia procedures. Any outsourced tests are performed under ABL’s quality system management by approved vendors. ABL’s analytical services cover methods development, transfer & optimisation through to 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:

General / Physical

Appearance
pH
Osmolality
Extractable volume
Container closure integrity
Cell viability
Intact cells

Product Specific

Infectious titer (PFU)
Viral genomes (qPCR)
Genomic integrity & identity
Transgene expression
Functionality bioassays
Identity (cells, virus, insert)
Genetic stability
Selective tumour cell killing

Purity

Total protein
Host cell protein
Host cell DNA
Process related impurities (BSA, Benzonase, Serine proteases, etc.)

Safety

Endotoxin
Bioburden
Sterility
Observation
Hemadsorbing viruses
Extraneous agents
Adventitious virus (in-vitro)

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