Biologics Packaging Presents Risks
Biological drugs are growing in tandem with an aging, longer-living population. At the same time, biological drugs are very challenging to stabilize and administer due to their larger dosage and complexity, sensitivity and viscosity. Risks include extractables, glass delamination, particles and siliconization. But new prefilled syringe packaging options offer potential solutions to these risks.
Risks Associated with Extractables
Increasing regulatory and compendial attention is being paid to extractables, substances released from the complete drug packaging system after stress treatment (e.g., long-time and high-temperature exposure). In particular, special attention is being placed on tungsten, a material used during glass tip-forming operations. Recent studies show that soluble tungsten polyanions may cause precipitation and/or aggregation of biomolecules, reducing drug efficacy and increasing the risk of immunogenicity.