cGMP MANUFACTURING
cGMP MANUFACTURING
cGMP MANUFACTURING FOR VIRAL VACCINES
Advaxia offers state-of-the-art facilities and tools for production at every scale.
At Advaxia, we recognize that vaccine manufacturing under cGMP conditions requires careful adherence to regulatory guidelines, from pre-GMP all the way to production and on-site delivery for clinical trials. Because the final product will be used on humans, it is crucial to ensure that every dose is free of contaminants and of the highest possible purity.
That’s why we have spent the past ten years perfecting a wide array of vaccine production pipelines, in alignment with the latest technology enhancements, as well as with the guidelines set forth by regulatory agencies around the globe.
Our major strengths in cGMP vaccine manufacturing include all the following:
- Production and characterization of GMP-compliant Cell Banks
We manufacture mammalian cell cultures both in adherent and suspension culture conditions by using different size, single-use cell bioreactors. Master Cell Banks (MCB), Working Cell Banks (WCB) and End-Of-Production Cell Banks (EOP) are produced within our GMP facility and subjected to extensive characterization. - Production and characterization of GMP-compliant Virus Banks
We produce primary infection stocks in GMP facility, by infecting MCB cells with pre-GMP adenoviral seeds produced using cGMP-grade materials in our process development laboratories. We offer extensive genetic characterization of the seed, as well as a preliminary assessment of infectivity and titer. - Clinical batches manufacturing
Our GMP facility supports vaccine manufacturing across a variety of process scales, up to 250L scale size in single-use stirred bioreactor. The whole process relies on a fully disposable pipeline based on single-use materials and equipment to ensure product quality and flexibility. Efficient reduction of contaminants such host cell proteins and host cell DNA is guaranteed by an effective combination of filtration and AEX chromatography steps. - Fill and finish of Drug Products
We fill vials with formulated drug product under aseptic conditions, creating packaged doses ready for administration to human test subjects in clinical trials. Our current fill-and-finish area is a Class B / Class A (BSC, LAF) environment, containing a semi-automated filling/crimping machine (Flexicon) under LAF, delivering up to 1,000 vials per batch of multiple products. Ongoing expansion is nearing completion of a second fill-and-finish area with a fully automated filling line (Flexicon) under cRABs (Franz Ziel). Qualification of our new filling line, with capacity up to 2,700 vials per hour (45 vials/min) is anticipated by the end of 2022.
We uphold rigorous product quality standards through a wide variety of interrelated approaches, from the design of our facility, to the selection of state-of-the-art laboratory equipment, to the choice of raw materials for every pilot batch and GMP production run.
Moreover, we maintain a proactive and vigilant self-improvement posture, relentlessly seeking opportunities to further improve our processes and operations, personnel training and qualification standards, and regulatory compliance.