Process Development

Downstream Development

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 CMAB has established a platform for purification process which can quickly bring our client's product into the manufacturing phase. Our purification laboratory is equipped with multiple ÄKTA systems to handle several projects simultaneously.

Our downstream processing will in general include an affinity chromatography step, ion exchange steps and/or mix-mode steps, a virus inactivation step (low pH or S/D incubation), a virus removal step (nanofiltration), and buffer exchange steps (ultra-filtration).

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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