Our on-site release, in-process testing, and stability studies provide you with time saving performance that is critical to IND, IMPD and early-phase clinical studies. We use ICH-compliant protocols to monitor the stability and release readiness of your product.

Our analytical team is in direct communication with your clinical development team consistently sharing data, coordinating schedules, and planning upcoming tests.

Services

• Specification development for release and stability testing
• Protocol development for stability testing
• Cumulative reporting and trend analysis
• ICH/cGMP compliant protocols/stability programs
• Method transfer and optimization
• Long-term and accelerated stability studies
• Full analytical development, qualification/validation, and cGMP testing
• COA generation and issuance
• Full limited-access controlled facility and storage chambers
• 24-hour computer-monitored facilities
• Redundant back-up electrical power and HVAC
• Photostability testing under ICH Q1B or custom conditions
• Determination of retest dates and expiration dates
• Submission-ready reports

In-Process and Release Testing

• UV (A280)
• BCA, Bradford
• ELISA, Western blot
• HPLC, SDS-PAGE, IEF
• CE (CE-SDS, cIEF, CZE)
• LC-MS
• Mass Spectrometry
• Bioburden
• qPCR
• Endotoxin
• Appearance (USP/EP)
• Osmolality
• Residual moisture
• pH
• HIAC and MFI
• NP-HPLC, CZE
• Enzymatic activity