Comprehensive Analytical Characterization for Reagent Development and Release
Biological reagents must perform consistently across production runs and regulatory reviews. Variability can delay development timelines or compromise downstream processes.
BA Sciences offers complete biological reagent testing services, supporting every stage from analytical development and validation through batch release and stability studies.
Biological Reagent Testing Services
Our laboratory provides extensive analytical capabilities to characterize biological reagents and confirm product integrity across a wide range of applications.
Impurity Testing: Testing includes process and product impurities as well as residual solvents to confirm product quality and consistency. Methods are developed and validated to align with cGMP and regulatory expectations.
Microbial Testing: Microbial assessments include sterility, endotoxin, and bioburden testing, as well as microbial identification using MALDI-TOF and MicroSEQ. Enumeration is performed following USP <61> and <62>.
Identification: We identify biological reagents using FTIR, mass spectrometry, HPLC/UPLC, thermal analysis, and capillary electrophoresis to confirm product composition and integrity.
Assay, Potency, and Purity Testing: Assays are performed to confirm potency and purity using ELISA and HPLC/UPLC. These methods ensure the accuracy and consistency of biological reagent performance across production runs.
Stability Studies: Stability testing is conducted under ICH conditions, with automated freeze–thaw and photostability studies available. Chambers are continuously monitored (24/7) to ensure controlled storage environments.
Residual Reagent Clearance: For reagents incorporated into pharmaceutical manufacturing, we develop and qualify residual reagent clearance tests that integrate with client methods, minimizing additional validation efforts.
Batch Release Support: Batch release services include protocol development, stability testing, and storage studies to evaluate long-term viability. Each program is customized to the formulation, intended use, and submission strategy.
