Quality control

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.

QC release and ICH stability testing capabilities include: 

General / Physical   Appearance, pH, osmolality, extractable volume, container closure integrity, cell viability, intact cells
Product SpecificInfectious titer (PFU), viral genomes (qPCR), genomic integrity & identity, transgene expression / functionality bioassays, HPLC titer, identity (cells, virus, insert), genetic stability, selective tumour cell killing
PurityTotal protein, host cell protein, host cell DNA, process related impurities (BSA, Benzonase, Serine proteases, etc.)
SafetyEndotoxin, bioburden, sterility, observation, hemadsorbing viruses, extraneous agents, adventitious virus (in-vitro)