Quality Control Star...
31st August 2021 Content supplied by: Sartorius AG
Addressing Challenges of Quality Control Labs in Vaccine Manufacturing
The QC of vaccines relies on the control of starting materials, production process, and final product. It has been estimated that about 70% of the production time of a vaccine is dedicated to quality control. Fortunately, technological advances are streamlining test processes and increasing efficiencies.
- Rapid methods, like our Microsart® qPCR kits, offer a method for early detection of mycoplasma contamination in culture-based manufacturing. These kits are fast, highly specific, sensitive, and compliant with international guidelines.
- Microbial enumeration (bioburden) testing is an in-process quality control measure for demonstrating safety and performance at multiple stages of the manufacturing process, from raw materials to final drug product.
- Membrane filtration is the regulatory-preferred method for microbial enumeration testing of liquids (USP<71> and Ph. Eur. 2.6.1). Our Microsart® @filter combined with the Microsart® @media is a unique system that effortlessly positions the membrane on the agar plate completely touch-free. It is easily locked and ready to incubate, reducing the risk of contamination.
- Sterility testing is a key product release QC parameter, ensuring that viable microorganisms are not present as contaminants in the final parenteral products. Our Sterisart® devices allow aseptic sampling of the sterile canister during the incubation time via a septum port, ensuring compliance with global regulations.
- Octet® Bio-Layer Interferometry (BLI) platform can be used for impurity lot release assays, ligand binding potency analysis, as well as to develop stability indicating methods that assess changes in activity through stressed and forced degradation assays.
- Air Monitoring is a key requirement in sterile pharmaceutical production environments and part of the biocontamination control strategies described in related standards and guidelines, such as the EN 17141 and the recently revised EU GMP Annex 1. The MD8 Airscan® command unit utilizes a single, sterile gelatine membrane filter to capture and retain even the smallest airborne microorganisms, even viruses, over an 8-hour period. This USP-approved membrane filter can then be placed on any standard agar plate for routine incubation per environmental monitoring protocols.
Sartorius offers a broad range of technologies that facilitate quality control testing methods for vaccine production while complying with regulatory requirements.
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Date Published: 31st August 2021
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