Development of Protein-Like Reference Material for Semiquantitatively Monitoring Visible Proteinaceous Particles in
Srivalli Telikepalli1, Kristen Gonzalez2, Sonia Dragulin-Otto2
1Biomolecular Measurement Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD; srivalli.telikepalli@nist.gov.
PDA Journal of Pharmaceutical Science and Technology
|June 19, 2019
Summary
A new ethylene tetrafluoroethylene (ETFE) particle standard effectively mimics protein particles, aiding in monitoring biopharmaceutical quality. This standard helps identify potential stability issues during drug development.
Area of Science:
- Biopharmaceutical Development
- Analytical Chemistry
- Materials Science
Background:
- Visible particles in biopharmaceuticals can raise safety and efficacy concerns.
- Proteinaceous particles may be acceptable if characterized, unlike non-proteinaceous ones.
- Monitoring protein particles in biopharmaceuticals presents challenges.
Purpose of the Study:
- To evaluate abraded ethylene tetrafluoroethylene (ETFE) as a visible protein-like particle standard.
- To demonstrate a semiquantitative method for monitoring proteinaceous particles using ETFE.
- To assess ETFE's suitability for formulation and analytical development.
Main Methods:
- Abraded ethylene tetrafluoroethylene (ETFE) particles were prepared.
- A semiquantitative method was developed to use ETFE as a surrogate standard.
- ETFE particle behavior was compared to protein particles and polystyrene microspheres.
Main Results:
- ETFE particles demonstrated a better mimicry of protein particles' appearance and behavior in solution.
- Polystyrene microspheres were less effective mimics compared to ETFE.
- The developed method showed ETFE's potential as a viable standard.
Conclusions:
- Abraded ETFE is a promising standard for visible protein-like particles in biopharmaceuticals.
- The ETFE standard and method can aid in non-destructive identification of stability problems during development.
- This approach supports enhanced quality control in biopharmaceutical formulation.
Keywords:
Ethylene tetrafluoroethyleneProtein aggregationProtein particle standardProteinaceous visible particlesProteinsStabilityMore Related Videos
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