CMC: Analytical Development

CMC offers an extensive range of analytical services to evaluate the integrity, purity, structure, and function of complex biologicals. This in-house capability means that we can provide almost all the analytical testing required for cGMP production, thus ensuring complete control over the project schedule.

Analytical development, validation, transfer and quality control
Pharmacopoeial testing methods and equivalency studies
Analyses of raw materials, intermediates and final API's
Stability testing
Development reports & review of CMC sections
Analytical techniques such as

HPLC techniques: SE, IE, RP, HIC, with UV-Vis, Fluorescence, PAD and conductivity detection
Electrophoresis (e.g. SDS-PAGE, IEF)
QPCR for residual DNA
Endotoxins (LAL)
Residual host cell proteins (HCPs)
Carbohydrate analyses
Spectroscopic methods (UV-Vis, NIR)
Peptide mapping
Residual moisture by Karl Fischer and loss on drying
Mass Spectrometry
pH and conductivity
Western Blotting
ELISA based methods (e.g. activity and quantification)
Cell based Bioassays (non-radioactive)
Potency and activity Assay
Bioburden
Plasmid retention
Other microbiological analysis (pharmacopoeial and customer specific)


CMC offers an extensive range of analytical services to evaluate the integrity, purity, structure, and function of complex biologicals. This in-house capability means that we can provide almost all the analytical testing required for cGMP production, thus ensuring complete control over the project schedule. Analytical development, validation, transfer and quality control Pharmacopoeial testing methods and equivalency studies Analyses of raw materials, intermediates and final API's Stability testing Development reports & review of CMC sections Analytical techniques such as HPLC techniques: SE, IE, RP, HIC, with UV-Vis, Fluorescence, PAD and conductivity detection Electrophoresis (e.g. SDS-PAGE, IEF) QPCR for residual DNA Endotoxins (LAL) Residual host cell proteins (HCPs) Carbohydrate analyses Spectroscopic methods (UV-Vis, NIR) Peptide mapping Residual moisture by Karl Fischer and loss on drying Mass Spectrometry pH and conductivity Western Blotting ELISA based methods (e.g. activity and quantification) Cell based Bioassays (non-radioactive) Potency and activity Assay Bioburden Plasmid retention Other microbiological analysis (pharmacopoeial and customer specific)