Meridian Life Science, Inc. offers a full suite of process development capabilities both upstream and downstream along with the ability to perform feasibility and scale up pilot production runs prior to potential cGMP production. Meridian Life Science, Inc. employs a highly trained staff (many with terminal degrees in biochemistry, virology, immunology, and microbiology) in cell culture, virology, protein expression, protein purification and characterization.
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- Cell line development
- Production of cell and virus stocks
- Cell culture optimization
- Evaluation of Media and cell culture conditions
- Analysis of Multiplicities of Infection
- Determination of cell viability and/or infectious particles
- Various harvest and/or cell disruption methods:
- sonication
- micro fluidization
- chemical lysis
- Pilot production and cell culture scale-up
- Ability to conduct pilot production runs fully representative
of cGMP scale
- Flasks, spinner flasks, roller bottles, cell factories and disposable
bioreactor bags
- Analytical test method development and validation
- Viral quantitation and infectivity:
- Plaque
- TCID50
- FFA
- Immunoassay
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- Protein purification development
- Chromatography methods to maximize yield and minimize contaminants:
- Size Exclusion
- Anion and Cation Exchange
- Hydrophobic Interaction
- Immunoaffinity chromatography methods
- Filtration:
- Micro/ultra filtration
- diafiltration
- depth
- CFF
- TFF
- Precipitation methods
- Centrifugation and gradient centrifugation
- Formulations experience for VLP and viral vaccines
- Process validation
- Meridian Life Science has invested heavily in the necessary staffing, equipment and infrastructure to support both R&D and cGMP projects.
- Available equipment includes:
- two ÄKTA Pilots
- ÄKTA Explorer
- ÄKTA Prime
- ÄKTA Ready
- Agilent Technologies 1200 series HPLC
- Various ultracentrifuges
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