Process Development

Cell-line Development

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CMAB has developed a platform process for stable cell line development. We combine cell line development with upstream process development to reduce timeline significantly. Furthermore, we provide single cell imaging data to support regulatory filing.

Separate areas are provided for upstream development, downstream development, solution preparation, stability, and analytical development.

• Three cell culture rooms for media development.
• Controlled-rate freeze system for cell banks.
• Quarantined Research Cell bank (RCB) storage.
• Cell culture bioreactors from 2L to 200L for process development, optimization, and production of gram-quantities.
• Filtration, chromatography, and ultrafiltration purification systems from milligram to gram quantities.
• Full analytical support including Mass Spectrometry (LC-MS).
• Formulation development equipment including controlled-rate freeze/thaw and pilot lyophilization.

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