Cell Culture Media Stability and Testing Services

Project resources matter in today’s fast-paced biopharmaceutical market, making outsourcing a smart choice if you prefer to direct your valuable internal resources toward other core goals. To achieve your project timelines, let our Media Stability and Testing Services share your workload.  

Media stability service

When custom products require you to establish and support an assigned expiration date, we can initiate the stability study in coordination with your cell culture product manufacturing. The data we generate allows you to make the right decision for your product shelf life assignment. Our tailored approach features:

• One-to-one consultation to define the study protocol
• Protocol selections for time points of testing, storage temperatures, and tests beyond product specifications
• Study service available for liquid and dry powder cell culture media, feeds, supplements, and buffer solutions

Because reliability is a must, we review and compare all data to starting point values, based on testing that is aligned with the same standards as your product release testing. Major changes are communicated to you upon discovery. You will receive a report with testing results after each time point and at the conclusion of the study.

Standard product release specification tests:

• Visual Test/Sigma Color Chart
• pH Meter
• Osmometer
• LAL Chromogenic
• Bioburden Membrane Filtration
• Hydration Instructions

Optional tests:

• Growth Promotion
• Density
• Amino Acids (not Cysteine)
• B12 Vitamin w/ Folic Acid
• Particle Size
• Linoleic
• Lipoic
• Pluronic
• Fatty Acids
• Cholesterol
• Cysteine
• Moisture (KF)
• Glucose
• Turbidity
• Trace Elements (10)
• Mycoplasma
• Standard Elements