AAV Biosafety

There are several other quality control (QC) tests commonly performed to assess the purity, safety, and efficacy of AAV preparations.

Some of these tests include:

  • Endotoxin testing: Endotoxins are bacterial lipopolysaccharides that can be present in AAV preparations if the production process involves bacterial contamination. Endotoxin testing is performed using methods such as Limulus amebocyte lysate (LAL) assay to detect and quantify the levels of endotoxins in the AAV sample.
  • Mycoplasma testing: Mycoplasma contamination can occur during the production process and can affect the quality and safety of AAV preparations. Mycoplasma testing involves methods such as PCR-based assays or culture-based methods to detect the presence of mycoplasma contamination in the AAV sample.
  • Bioburden testing: Bioburden testing is performed to assess the level of microbial contamination in the AAV sample. It involves methods such as microbial enumeration or total viable count to quantify the number of viable microorganisms present in the AAV preparation.
  • Sterility testing: Sterility testing is conducted to confirm the absence of viable microorganisms in the AAV product. It involves culturing the AAV sample under appropriate conditions to detect any microbial growth.
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These tests are important for ensuring the safety and quality of AAV preparations for use in gene therapy applications. Performing comprehensive QC testing helps to identify any potential contaminants or impurities that may impact the efficacy and safety of the AAV product.