FDA revises guidance on work with spore-producing organisms for biologics


WASHINGTON The Food and Drug Administration has issued new guidance telling biological drug manufacturers that spore-bearing organisms used to make vaccines and other products may now be worked on in a contained portion of a larger plant.

Due to the hazards that some spores pose, the old guideline read that  “all work with spore-bearing microorganisms (spore-formers) be conducted in an entirely separate building or in a completely walled-off portion of a multi-product building,” with entrances separate from the rest of the plant. The FDA no longer requires the use of specifically dedicated buildings for this work.

Since 2004, the FDA has been issuing guidelines to allow for more flexibility for drug manufacturers.

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