Bioassay (or biological assay) is a biological testing procedure for determining the efficacy of a pharmaceutically active substance in a formulated product or bulk material by observing their effects on living animals (in vivo) or tissues (in vitro). In contrast to common physical or chemical methods, bioassays produce detailed information about the biological activity of a drug substance.

Bioassays also include the detection of biohazards, the quality assessment of mixtures, their impact on the surrounding environment, and the assessment of the environmental impact and safety assessment of new technologies and facilities.

Creative Biolabs’s expertise in bioassay and the experience gained from our hundreds of projects have enabled us to work closely with our clients to provide scientific and experimental expertise in the design and implementation of tailored bioassays. The development, optimization, validation and performance of our biological/potency assays are carried out in accordance with GMP regulations. Validation strategies are based on international guidelines and recommendations (e.g., ICH, US-FDA, ISO, EMEA).

Key Benefits

  • ✔ Develop and optimize tailored bioassays (FDA approved)
  • ✔ Validate custom bioassay (FDA approved) according to international guidelines and recommendations (e.g., ICH, US-FDA, ISO, EMEA)
  • ✔ Quality Control: Batch release testing and stability testing in accordance with GMP / GLP regulations (FDA approved)

Please feel free to contact us for more detailed information.

For lab research only, cannot be used for any clinical use.

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