Dear Forum,
A few questions regarding bacteriophages (phage) in microbial fermentation
plants:
1. What precautions are normally included in the design and layout of
microbial fermentation plants for manufacturing biopharmaceutical API’s in
order to avoid phage infections from the surrounding environment.
2. What cleaning/sterilization methods are applied in order to ensure that
phages are effectively removed from multi product fermentation equipment for
manufacturing biopharmaceutical API’s.
A/ between fermentation batches even if no phage infection is
detected
B/ after a detected phage infection
3. If a strain that is knowingly infected with a well defined phage – such
as e.g. the lambda DE3 phage system that is widely used in E. coli – is used
for a fermentation batch, what cleaning/sterilization methods or other
precautions are or should be taken to prevent infection with this phage of
the following fermentation cultures for manufacturing of biopharmaceutical
API’s.
4. What general and specific phage detection methods are in use in
fermentation plants for manufacturing of biopharmaceutical API’s.
Thanks in advance
Tony Christensen
Consultant - PharmProTech
toch@pharmprotech.dk
Denmark
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