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Microbial test method establishment for pharmaceutical manufacturing

We develop and establish the test methods necessary for microbial control throughout pharmaceutical development, prepare the test systems, and contribute to the maintenance of the quality of manufacturing facilities and pharmaceuticals.

  • Establishment of microbiological test methods (sterility test, endotoxin, microbial limit test, etc.) of drug substance and various drug products.
  • Solution by rapid identification for environmental microorganisms using MALDI/MS.
  • Establishment of microbiological procedures for manufacturing control.
Microbial test method setting for pharmaceutical manufacture

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SPERA provides CMC solutions from early-stage through new drug application.

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