Cell Storage and Stability Testing

Cell Storage

In tandem with our Cell Banking, Cell Characterization, and Stability Studies, we provide a safe, cGMP-compliant facility for the storage of your Master, Working, and End-of-Production (EOP) cells and/or limit of in vitro cell life.  Charles River facilities are controlled and monitored by a fully-validated Datatron monitoring system with redundant generator power, operating 24-7 with an alarm system to fully comply with FDA and ICH guidelines.

Stability Studies

The broad spectrum of Stability Studies available through our Biopharmaceutical Services addresses the specific label claims of your product such as cell line stability, formulation evaluations, clinical supplies and released product degradation.

Charles River provides full-service analytical development and validation in combination with real-time and accelerated stability testing. Our facilities include dedicated walk-in storage rooms with electronic environmental control and monitoring systems. All ICH QIA(R) conditions, as well as other special conditions such as 25°C/75% RH and -70°C, are available.

A wide variety of testing techniques have been established allowing for full characterization and stability testing of new chemical and biological entities and their associated finished products. Our services give you an economic and flexible alternative to maintaining in-house facilities.

Sample Submission Forms

Data Sheet: Mammalian Cell Bank Characterization Services

Data Sheet: Microbial Cell Bank Characterization Services

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