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Mycoplasma Detection in Biopharmaceuticals

Format: PDF file | Document type: White / Technical Paper

The detection of mycoplasma contamination is of utmost concern in bio-therapeutic and vaccine manufacturing. The two pharmacopeia techniques rely on the agar/broth culture test to detect cultivable mycoplasma, along with the indicator cell culture assay. The main drawback with these protocols is that they take 28 days and about one week to complete respectively. This timescale is problematic for products whose shelf-life is short. For this reason, more rapid alternatives are routinely accepted by the regulators, as long as they are well validated.

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