In Vitro Monoclonal Antibody Production

Meridian Life Science, Inc. has the experience necessary for cell culture-based monoclonal antibody production to meet your quality and critical timing requirements. We can optimize the production process for maximum yield, serum-free production and production of high quality antibodies in a wide range of buffers and concentrations.
        

Cell Culture Production Services
        
        

Pilot Run Option:

    * Small scale run for yield determination

    * Custom production and optimization

    * Specifications: Process and purity testing

    * Fixed production pricing after pilot run

        

Production:
        

    * CL1000 Flasks (small)

    * WaveBag® (medium)

    * CelliGen® Bioreactor (large)

    * Media optimization

    * Serum free media option



QC Testing and Release:
           

    * Purity (SDS-PAGE) / Activity (ELISA)

    * Protein Concentration

    * Sterility and Mycoplasma Testing

    * Test Method Validation

    * Fill and Finish

        

Large Scale Cell Culture Production:
              

    * CelliGen Bioreactor for large scale production

    * Up to 80 grams of antibody per run

    * Unique continuous perfusion process

    * Faster, more consistent production than Hollow Fiber

    * Less labor to set up; less prone to contamination

    * Better control of cell growth parameters

    * Pilot run offered at 2 gram level

    * Turnaround time from 3 to 12 weeks

    * Competitive bulk pricing close to Ascites production cost

        
Our quality system is compliant with applicable device GMPs enabling adaptation of your production/manufacturing process to be conducted under GMPs.

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