QUALITY CONTROL
QUALITY CONTROL
Advaxia meets or exceeds global quality standards in every product and process.
At Advaxia, we pride ourselves on adhering to the world’s most demanding quality standards — and excelling beyond them.Â
Our dedicated quality control (QC) team relentlessly seeks out opportunities for improvement to our capabilities, equipment, staff training and associated procedures, with the aim to meet or exceed the requested pharmacopeia standards. As a result, we can boast an unparalleled 100-percent successful track record in the approval and release of the vaccines and other biotechnology pharmaceuticals we manufacture for our clients.
Exceptional quality is our baseline, and perfection is our never-ending pursuit.
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:
- Cell-based assays;
- In vitro potency assays;
- Genome quantification;
- Molecular biology methods;
- Detection and quantification of impurities such as endotoxins and host cell DNA and host cell protein (HCP).
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.