Adello

Background

Assist with their BLA filing for the biosimilars of Filgrastim and Pegfilgrastim drug products (pre-filled syringes and vials) with the FDA. Execute and summarize the shipping lane validation studies prior to the BLA submission. Allow greater preparation and increased the submission information—avoiding significant questions and potentially proscriptive remedies imposed by the FDA.

Objectives

  • Review existing qualification reports and shipping validation studies.
  • Design and execute operational qualifications (OQ) for shipping lanes.
  • Design and execute plunger movement studies for pre-filled syringes.

Results

  • Summary of validation activities provided results to understand risks and any controls required.
  • Drug product OQ simulation conducted and provided positive results for product quality.
  • Execution support of protocol design, documentation, and training on pack out instructions.

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