Accelerated Testing of Protein Stability Using the Aggregates Sizer TC (With Temperature Control)

Biopharmaceuticals contact a variety of materials during their production, storage, and transport that include metal, plastic and glass. Protein stability differs depending on the materials it comes into contact with. We conducted accelerated stability testing of proteins via the monitoring of aggregate formation during application of physical stress at constant temperature. Three agitator plate materials (PEEK, stainless steel, and glass) attached to the "Aggregates Sizer TC (with temperature control)", Aggregation Analysis System for Biopharmaceuticals was used for testing. The results we obtained indicated the importance of temperature control for stability testing and suggested different materials have different effects on aggregation.

Content Type:
Application
Document Number:
LAAN-A-PT-E007
Product Type:
Life Science Lab Instruments, Bio Pharmaceutical
Keywords:
Biopharmaceutical, Antibody preparation, Aggregation, Aggregate formation, Protein, Protein preparation, SVP, Sub visible particle, qLD method, Quantitative laser diffraction method, IgG,γ-Globulin, Accelerated testing, Stress test, Stability test, Quality evaluation, Storage container, FDA, Pharmaceutical, Life Science, Aggregates Sizer TC
Language:
English
File Name:
jpi516005.pdf
File Size:
346kb

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For Research Use Only. Not for use in diagnostic procedures.

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