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Batch & Lot release assays for Biologics

Potency testing is critical for product activity comparison, the regulatory submission, and batch or lot release of Bio-pharmaceuticals. Most importantly, bio similar products need to be demonstrating the product efficacy and manufacturing batch consistency. These analyses are routinely done through in vivo or in vitro bioassays, as per regulatory guidelines. Since the potency assays are essential in conforming product quality, it is critical to cross verify the in-house data with a common testing partner to understand product quality and also to verify the quality of assays.

Tamilnadu Test House offers bio-potency assay service as per Indian DCGI (CDSCO), FDA and EMA guidelines. Customized potency assays are also developed and validated. With a huge experience in assay development, validation, screening and transfer, Tamilnadu Test House adds considerable value for support of clinical trials and as well as batch or lot release and stability testing. Tamilnadu Test House offers the assessment of parallelism in the comparison molecules. We can offer our assay range and technical expertise as  below:

  • Proliferation & inhibition
  • Cytotoxicity
  • Neutralization Assays
  • ADCC, ADCP and CDC
  • Reporter gene expression
  • Cytokine and chemokine release
  • Functional assay