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.
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- 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
