Sub-visible particle quantitation in protein therapeutics.

Area of Science:

• Pharmaceutical Science
• Analytical Chemistry
• Biotechnology

Background:

• Biologics are a significant and expanding part of the pharmaceutical market.
• Sub-visible particles in biologics pose potential patient safety risks and require thorough investigation.
• Consistent particle control from development to commercial release is essential for therapeutic biologics.

Purpose of the Study:

• To address the limitations of compendial methods for sub-visible particle quantitation in biologics.
• To present modifications of the light obscuration method for biopharmaceutical applications.
• To demonstrate a strategy for particle analysis across the product lifecycle.

Main Methods:

• Modification of the compendial light obscuration method.
• Adaptation for various protein concentrations and administration routes.
• Development of optimized sample preparation and sampling plans.
• Application to therapeutic protein products.

Main Results:

• Demonstrated successful application of the modified light obscuration method to therapeutic protein products.
• Showcased enhanced sizing information and reduced assay volumes.
• Presented a viable strategy for particle analysis in biologics.

Conclusions:

• The modified light obscuration method is suitable for sub-visible particle quantitation in therapeutic biologics.
• A comprehensive strategy utilizing complementary methods ensures robust particle control.
• Accurate particle analysis is critical for ensuring the quality and safety of biologic drugs.