Advaxia Biologics

QUALITY CONTROL

Close up of adenovirus based vaccine vial being held by Quality Control specialist

QUALITY CONTROL

IN-PROCESS CONTROL
SAMPLE ANALYSIS

We collect a wide array of in-house data throughout every manufacturing run, monitoring every step of the process, material, operational environment, and piece of equipment to ensure it continues to operate effectively and efficiently.

FINISHED PRODUCT
ANALYSIS

Our QC team conducts a battery of tests on each batch of product, ensuring that its potency, purity, and other characteristics are in full alignment with the specifications provided by the client, and dictated by the regulatory authorities.

All our QC staff are trained and equipped to perform a wide variety of analytical tests for recombinant virus products, including PCR, qPCR, SDS-PAGE, ELISA, LAL, spectrophotometry (UV/visible), electrophoresis, immuno-staining assays, restriction analysis, western blot analysis and mycoplasma testing.

Our QC laboratory also performs additional assays such as pH, appearance, osmolality, extractable volume, filter integrity, and residuals (host cell protein, host cell DNA and benzonase). We have extensive experience in all the following techniques:

We’re also experienced in helping our clients choosing test methods appropriate for each process stage and product, according to validation characteristics such as accuracy, precision, repeatability, intermediate precision, specificity, detection limit, quantitation limit, linearity, and range.

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