Stability Testing of Biopharmaceutical Products

Test different environmental conditions over a defined timeframe.

Determine proper shipping and storage conditions for the product, as well as a proper shelf life or retest period.

Customized Stability Study Design

Design studies GMP and GLP or non-regulatory studies to meet requirements and your project needs.

Offer a controlled, transparent, and clearly documented process for every study with thorough recordkeeping and reporting.

We have various storage chambers with electronic monitoring and documentation support.

Cell, Gene, and Protein Characterization

Biopharmaceuticals such as proteins, peptides, vectors, cells, and nucleic acids have special stability testing requirements.

We can use both Real-Time and Accelerated Stability Tests to determine ideal storage conditions and establish a recommended shelf life.

Biopharmaceutical products stored in elevated stress conditions such as heat, oxidation, light, or humidity are studied for modifications and degradation.

Bioanalytical characterization may include tests for identity, purity, concentration, potency, and chemical modifications.

We utilize cell-based assays, ligand binding assays, spectrophotometric analysis, molecular biology, and biochemical tests to characterize stability and other quality attributes of your biopharmaceutical product.