Simple In-House Mycoplasma Testing Method for Regulatory Expectations and Rapid, Confident, and Actionable Results

Mycoplasma contamination is a risk to cell-based biologics manufacturing, potentially jeopardizing patient safety and product quality. Therefore, regulatory guidance globally requires manufactures to routinely employ a validated mycoplasma detection strategy for lot-release of their drug product. Beyond meeting regulatory expectations, the implementation of an in-house mycoplasma testing method is extremely valuable, providing companies with rapid, actionable data for both lot-release and raw materials testing, saving both time and money.

The introduction of live mycoplasma or live mycoplasma cultures in production facilities is not ideal. Regulatory guidance has evolved to include rapid molecular methods that do not require live cultures or live mycoplasma, but its important to implement a testing method that meets sensitivity and specificity requirements and is validatable per industry expectations.

In this webinar, we present an overview of worldwide regulatory guidance for mycoplasma testing, as well as a mycoplasma testing method that has been accepted by regulatory authorities worldwide across various therapeutic modalities. Experience will be shared using purified genomic DNA for limit of detection validations. We will simplify other common challenges and learnings from a decade of experience, such as the selection of a representative sample in cell therapy products and techniques for sample preparation to help achieve regulatory requirements.

Key Takeaways:

  • An in-depth look at mycoplasma testing, regulatory guidance, and expectations.
  • Details of a highly sensitive, specific, and robust method for rapid mycoplasma detection with a strong regulatory acceptance track-record for lot-release testing.
  • Limit of detection validation scheme using genomic DNA instead of live mycoplasma.
  • Tips and tricks learned over 10 years of field support from sample selection, preparation, and validation guidance.

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