Analytical Method Development

Arranta Bio has dedicated LBP analytical development laboratories for development, customization, or customer transfer of LBP-based, product-specific methods. Arranta offers standard, pre-qualified assays to accelerate and support process development and performs compendial or modified compendial testing to meet its partners’ specific needs.

  • General, safety, purity, identify, and potency methods for aerobic and anaerobic organisms
  • Analytical method development, customization, qualification and validation
  • High-throughput methods for viability and growth recovery to support LBP process development
  • Molecular methods for identification and quantification of single organisms in a consortium
  • Testing support for non-cGMP stability studies

Quality Control Laboratories

Arranta Bio has comprehensive Quality Control in-house laboratories:

  • In-process and release testing of cGMP drug substance and drug product
  • cGMP ICH-compliant stability studies
  • Management of third-party testing laboratories for specific outsourced testing
  • Testing to support environmental monitoring of facilities and personnel

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