Gibco Bioprocessing Analytical Services

A spent media analysis provides you with rapid quantitative answers about changes to nutrient components and utilization profiles over time in your cell culture process. This analytical service is available for both fresh and spent media, as well as for a supplement analysis. Our team can provide you with data about the utilization profiles of amino acids, water-soluble vitamins, metabolites, trace elements, and other components in your media.

Turnaround time: 10 business-days*

Potential benefits

• Increase yield
  
• Increase titers
  
• Characterize your process
  
• Accelerate time-to-market
   

Standard media analytics offered**

Advanced media analytics offered**

*For most routine services. Additional time may be required for more complex services. Estimates will be provided based on the scope of work.

**Additional assays available upon request.

***LC: liquid chromatography; ICP-MS: inductively coupled plasma mass spectrometry; IC: ion chromatography; GC-MS: gas chromatography–mass spectrometry; NA: not applicable.

 ¹Analyte from Gibco GlutaMAX Supplement

Analytes within each assay

Assays and components may vary by site. Please discuss your specific requirements with your Thermo Fisher Scientific representative.

Our protein analytics services can help characterize your protein’s Critical Quality Attributes (CQAs) and Post-Translational Modifications (PTMs). This offering takes advantage of the use of:

• Protein aggregation analyses—providing information about the stability of your protein
• Glycan analyses—to understand the glycosylation profile of your antibody
• Charge variant analyses—to understand charge heterogeneity that can change throughout the biopharmaceutical production process as well as during purification and storage

Turnaround time: 10 business-days*

Potential benefits

• Streamline process development
• Improve the pharmacokinetics of molecules
• Improve molecular stability
• Improve protein quality
• Reduce variability

Protein analytics offered** 

*For most routine services. Additional time may be required for more complex services. Estimates will be provided based on the scope of work.

**Additional assays available upon request.

***LC: liquid chromatography; ICP-MS: inductively coupled plasma mass spectrometry; IC: ion chromatography; GC-MS: gas chromatography–mass spectrometry; NA: not applicable.

Customized advanced analytical projects are available through our investigative analytics service to help you troubleshoot any problems you may be facing in your process. If you are experiencing variability, the Key Driver Identification (KDI) approach—using advanced analytics techniques and mathematical modeling—may be utilized. Additionally, this service can help identify other media and process related issues, such as precipitation, and can include complete extractable and leachable studies.

Turnaround time: based on project scope

Potential benefits

• Identify causes of variability in performance 
• Create validated predictive models  
• Improve consistency and productivity

Gibco Media by Design Services offers real time stability testing of your Gibco catalog and custom products in their packaged form, under certain conditions and specific time points as determined by you. We have performed testing for industry, government and academia, and possess the capability to perform a variety of quality tests dependent upon the stability indicating factors for your unique formulation. Understanding the stability of your Gibco custom formulation over time is important for setting expiration dates for materials in your bioproduction process.

• As the manufacturer of your medium, we have expert knowledge to apply to your formulation
• Save time and money by eliminating the need to transfer samples from multiple lots
   

To comply with evolving regulatory requirements, biological therapeutic manufacturers are faced with the need to perform identification testing on media and buffers used in the manufacturing process of their therapeutic. Many regulatory agencies, such as the USFDA, now require identity verification testing on each batch of production raw materials to confirm that materials constantly meet specifications (USFDA Compliance Guidance Q7 GMP for Active Pharmaceutical Ingredients, section 7.3).

Thermo Fisher Scientific has the technology and expertise to help you develop a highly specific, rapid, and compliant identification test for your bioproduction raw materials with pass/fail results. Our identity verification method development service includes a detailed method development report, written test procedure templates (when applicable), electronic method files (when applicable), support for method transfer to your site, and method validation support.

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