If your company is considering fill-finishing a drug product in Blow-Fill-Seal, feasibility and stability testing is the first step.
ApiJect can recommend a basic protocol for initial assessment and compatibility of your drug product with Blow-Fill-Seal.
Certain factors will require consultation with your regulatory specialists and the relevant regulatory authorities. These factors may include regulatory filing, stability durations, conditions and required reporting.
If your company is uncertain whether it is worth having your drug product undertake stability testing, you can run compatibility testing beforehand to ensure the drug product is compatible with primary packaging in BFS.
In compatibility testing, your team can manually fill under a hood the drug product into a pre-formed BFS container and test it over the following months to build confidence that it is worth taking your drug product through a proper feasibility trial.