Protein/Peptide Characterization
x
Protein quantitation
Immunological assays
HPLC and UPLC-based assays for related substances and charged variants
Process residuals
Aggregate analysis by SEC and DLS
Process related impurities such as Host cell protein and Host cell DNA
Electrophoresis including Capillary electrophoresis and imaged capillary electrophoresis
Glycoform analysis including monosaccharide composition, glycan structure, glycosylation site determination by peptide maps, LC-MS/MS and NP-HPLC
Peptide mass fingerprinting and amino acid sequencing
Impurity characterization
Immunological assays
HPLC and UPLC-based assays for related substances and charged variants
Process residuals
Aggregate analysis by SEC and DLS
Process related impurities such as Host cell protein and Host cell DNA
Electrophoresis including Capillary electrophoresis and imaged capillary electrophoresis
Glycoform analysis including monosaccharide composition, glycan structure, glycosylation site determination by peptide maps, LC-MS/MS and NP-HPLC
Peptide mass fingerprinting and amino acid sequencing
Impurity characterization
Analytical Services
Method Development
Method transfer
Method Verification, Qualifications
Raw Material testing & release
Drug substance/API identification
Drug product in-process, release, and stability
Raw materials – excipients and intermediates
Reference standard qualification
Cleaning method development and verification/validation
Forced degradation studies
Impurity profiling
Material compatibility
Spike and recovery studies
Stability testing
Method transfer
Method Verification, Qualifications
Raw Material testing & release
Drug substance/API identification
Drug product in-process, release, and stability
Raw materials – excipients and intermediates
Reference standard qualification
Cleaning method development and verification/validation
Forced degradation studies
Impurity profiling
Material compatibility
Spike and recovery studies
Stability testing
