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Root Cause Analysis of Tungsten-Induced Protein Aggregation in Pre-filled Syringes
Wei Liu1, Rob Swift, Gianni Torraca
1Drug Product and Device Development, Amgen Inc., Thousand Oaks, CA.
PDA Journal of Pharmaceutical Science and Technology
|April 20, 2011
Summary
Tungsten particles from syringe manufacturing were found in protein solutions, causing protein aggregation. Optimizing syringe production and supplier communication is crucial for biotherapeutic quality and safety.
Area of Science:
- Pharmaceutical Science
- Materials Science
- Biotechnology
Background:
- Protein-based biotherapeutics are susceptible to aggregation.
- Particulate matter in injectable drugs can impact efficacy and safety.
- Syringe manufacturing processes can introduce leachables.
Purpose of the Study:
- To identify the source and impact of tungsten particles in protein solutions.
- To investigate the role of syringe manufacturing in tungsten contamination.
- To assess methods for accurate tungsten quantification in syringes.
Main Methods:
- Particle analysis of pre-filled syringes.
- Tracing tungsten origin to syringe barrel forming process.
- Tungsten recovery studies involving vacuum stopper placement.
- Evaluation of extraction procedures for residual tungsten.
Main Results:
- Tungsten particles and aggregated protein were identified.
- Tungsten originated from syringe manufacturing pins.
- Vacuum stopper placement significantly increased tungsten in solution.
- Supplier's washing process did not fully remove tungsten deposits.
Conclusions:
- Syringe manufacturing processes directly impact biotherapeutic quality.
- Accurate tungsten measurement requires wetting the syringe funnel area.
- Improved manufacturing and supplier collaboration are essential for preventing protein aggregation.
