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services

drug substance analysis

cell based activity assay method development, validation, and transfer
in-house reference standard characterization
analytical method development, validation, and transfer
drug substance release
stability study

quality study

structural characterization and related substance study
higher order structure analysis
charge variants analysis
biosimilar similarity study
comparability study

drug product analysis

analytical method development, validation, and transfer
drug product release
stability study
packaging material compatibility study
disposable material extractable/ leachable study

other services

raw materials and excipients release test
microbial limit test
sterility test
gmp facility validation and environmental monitoring support

technical capability

biochemical analysis

target antibody binding affinity
fc receptor binding affinity
genomic copies
hcp/dna/pro-a residue assay
mycoplasma test (q-pcr)

biological analysis

cytotoxicity test
fc function test (adcc/cdc)
immunofunction test
reporter gene assay
gene expression
viral testing

physicochemical analysis

protein content
purity (sec/ce-sds/hic/rp)
peptide mapping
charge heterogeneity (iec/icief/cze)
dar (uv/hic)
n-glycan profile and sialic acid
residue assay (solvent/free drug for adc)
excipient component assay

chatacterization

lc-ms (intact/reduced protein, sequence, disulfide bonds, ptm, payload and drug conjugation site for adc)
molecular interaction (spr/bli)
cd, dsc
sec-mals, auc
mfi
free thiol

advantages

comprehensive platform

integrated platform solutions for quality research and analysis of monoclonal antibodies, bispecific antibodies, fusion proteins, adcs, etc.
around 20 tumor cell lines in platform for bioassay, providing reporter gene assay
ability to establish detection cell lines for sample testing
adcc/cdc testing platforms

customized method development

comprehensive platform-based solutions for quality research and analysis covering monoclonal antibodies, bispecific antibodies, fusion proteins, and adcs, etc.
optimization and validation of analytical methods

cutting-edge equipment and an elite team

industry-leading instruments and equipment
professional and experienced team, with core technical experts over 7 years of experience in average. additionally, over 95% of the team members hold master’s degrees

laboratory