Adello Biologics
Shipping Lane Validation and Transport Simulation for Biosimilars Increases Confidence in BLA Filing
Challenge
Adello requested Modality Solution’s assistance to execute and summarize shipping lane validation studies prior to the BLA submission due date for filgrastim and pegfilgrastim drug products.
Objectives
- Review qualification reports
- Assist in-progress shipping validation studies
- Author transportation VWPs
- Design & execute OQs for shipping lanes
- Write validation reports for shipping lanes
- Design & execute plunger movement studies
- Summarize validation activities
Results
See how Modality Solutions helped Adello implement a detailed approach to transport validation, bringing them one step forward on the path to FDA approval.
Download the full case study