Process Development

Analytical Development

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At CMAB, our analytical laboratory is equipped with state of art analytical equipment to support product development at a very early stage to ensure quality. Our scientists are experienced in method development, qualification, validation.

CMAB's scientists are experienced in analytical method development, qualification and validation as well as having in-depth knowledge and knowhow in product characterization and comparability studies. We can provide all the methods required for an IND filing:

• HPLC and UPLC: Protein A, SEC, IEX, Glycan profiling, Polysorbate, Sialic Acid, HIC, Reverse Phase.
• CE-SDS: Reducing and non-reducing, cIEF
• ELISA: HCP, Protein A residue, Insulin Residue, custom antibody binding for your product.
• PCR: HCD, Mycoplasma
• Cell-based potency assays customized to your product
• Structural analysis

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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