The EMA says that food industry controls on porcine-trypsin do NOT guarantee that it is virus-free. The agency is therefore proposing new procedures for drug and vaccine makers who use it as part of their process.
EMA proposes virus testing for food sector-derived trypsin used in drugmaking.
This arises most recently from the rotavirus vaccine contamination event by porcine circoviruses that was ultimately traced to porcine trypsin used in its manufacture. Based on events like this, the EMA made new recommendations:
- Use only trypsin from glands from pigs that have appropriate official health certificates
- Test for specific viruses using both porcine and primate cell lines
- It advises use of two complementary virus reduction steps in processing -- e.g. low pH and irradiation
Under the guidelines proposed the drug or vaccine producer would have the responsibility to ensure proper testing (via its vendor if desired) and safety processing steps had been undertaken.
The EMA also noted that potential alternatives to trypsin could be used from recombinant sources or could be plant-derived (like TrypZean) saying ---- "the use of bacterial or plant derived recombinant trypsin minimizes in principle the risk for animal virus contamination and the application of such alternatives is therefore encouraged."
Posted by Bruce Lehr Mar 6th 2013.
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