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Mycoplasma Safety
Mycoplasma are infectious agents that may go undetected, are difficult to filter, and do not require a specific host for propagation. Testing protocols from the EMEA and FDA are "lengthy and convoluted". If you have concerns about mycoplasma detection technologies, protocols, or risk mitigation, we can help:
- We can help with routine lot release testing method review and interpretation
- If you've had a positive mycoplasma result, we can assist with investigation and remediation
- If you're ready for faster and more specific testing, we have experience with the wide variety of nucleic acid based mycoplasma methods, and we can help you find one for your application, or steer you away from something that looks sexy, but will be difficult to gain regulatory acceptance
- Using ICH Q8 tools, we can perform a risk mitigation exercise for mycoplasma