Elevate Your Bioprocess Insights with Cell Culture Media Stability and Testing Services
In the fast-paced biopharmaceutical market, optimizing resources is essential for success. By outsourcing your media stability and testing needs to us, you can focus on your core objectives while ensuring that your products meet the highest standards of quality and reliability. Our comprehensive Media Stability and Testing Services are designed to streamline your processes, accelerate project timelines, and provide the insights necessary for informed decision-making and process optimization. Partner with us to leverage both established and innovative testing methods, including our cutting-edge Cell Culture Media Fingerprinting Service for unparalleled accuracy.
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 at interim time points and at the conclusion of the study.
Media Testing Service
We also offer nutritional analysis on unused or spent liquid cell culture media, supplements, and feeds. Our testing service provides you with the nutritional component data needed to optimize your bioprocess. Testing can be performed on our GMP and/or ImMEDIAte ADVANTAGE® products.
To discuss your needs and receive a quote, contact us today. Our Media Stability and Testing Services are performed as a global service, with lead times varying depending on the scope of your project.
Tailored Testing that Yields Reliable Data
We offer a comprehensive range of standard and optional tests to help you reach your process and product development goals.
- Standard product release specification tests: Appearance, pH, Osmolality, Endotoxin, Bioburden, Solubility
- Optional tests: Growth Promotion, Density, Amino Acids (not Cysteine), Cysteine, Pluronic, Fatty Acids, Cholesterol, Moisture (KF), Glucose, Turbidity, Trace Elements, Mycoplasma, Standard Elements
Cell Culture Media Fingerprinting
Batch-to-batch variability in cell culture media compositions can jeopardize your process performance and product quality. Our CCM Fingerprinting Service provides simultaneous quantification of 100+ media components with unparalleled accuracy and efficiency. We have implemented this innovative analytical method as part of our custom cell culture media manufacturing service offering, empowering rapid and reliable component quantification and media identification.
Key Benefits
- Time & Cost Savings: Minimizes need for repeated testing and significantly reduces testing time up to 50%
- Security & Assurance: Information on degradation products, low and high-abundant components
- Increased Confidence: Reliable quantitation of components, relative or absolute
- High Sensitivity & Selectivity: Detects compounds as low as 1 ng/mL and specific compounds of interest even if they co-elute with others
Find more in-depth information on this novel analysis on our technical article "Cell Culture Media Fingerprinting: Ensuring Identity, Consistency, and Quality”.
Related Resources
- Flyer: SAFC® Media Stability and Testing Services
Outsourcing project resources in biopharma helps focus on core goals. Our Media Stability and Testing Services can support your timelines.
- Flyer: imMEDIAte Advantage® - Small Volume Custom Media
Our imMEDIAte ADVANTAGE® service offers pre-GMP custom media and supplements, ensuring quality and speed to accelerate your development.
- Brochure: Custom Media Development Services
Choosing the right cell culture medium is crucial for successful upstream processes, enhancing development speed and improving target molecule quality.
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