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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
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