LKtime Biotech's Analytical and QC Platform provides comprehensive lifecycle management support for the development of new biological products. Through close collaboration and seamless communication with various departments within the company, this platform ensures professional analytical method support at every stage. This includes target screening, developability assessment, preclinical CMC research, product characterization and quality control, CMC research during clinical phases, late-stage clinical sample production, pc/pv, and preparation of regulatory submission documents.
UPLC / 2D HPLC + Sciex 7600, supporting IEX, SEC, RP, HIC, HILIC assays.
- C/N terminal sequence analysis
- Protein sequence analysis
- Amino acid composition analysis
- Disulfide bond confirmation and mismatch
- Molecular size, charge isomer characterization
- Glycosylation (free sugar, glycopeptide, site analysis)
- Post-translational modification of amino acids (based on peptide map)
- Intact, reduced and desugarization molecular weight
- Identification of process impurities and precipitates
Bio-Inert HPLC / UPLC / 2D HPLC + UV / FLR / ELSD, supporting IEX, SEC, RP, HIC, HILIC assays.
- Disulfide bonds and free sulfhydryl groups
- PTMs: oxidation, isoaspartate, etc.
- Peptide map analysis
- DAR value/free toxin
- Molecular weight, charge isomers
- Excipient content and residue content
- Glycosylation (N-/O-), sialic acid content
- CE-SDS / CZE / CGE
- CIEF / iCIEF
- SDS-PAGE
- Western-Blot
- IEF
- Reporter gene assays
- Antigen-specific binding ELISA / cells
- Receptor and Fc affinity testing (ADCC / CDC)
- Proliferation inhibition assays
- PA / HCP / Avidin residues: ELISA
- DNA residue and mycoplasma: qPCR
- Extinction coefficient
- Functional testing (PFS, cartridges)
- Microbial limits and sterility
- Container tightness (color water assay, vacuum assay)
- Protein concentration
- Osmotic pressure, moisture
- Appearance, color, clarity, pH
- Insoluble particles
- Filling volume and reconstitution time
- PK / PD: ELISA
- ADA: ELISA
- Nabs: Cell assay
Agilent Liquid Chromatography
System
SCIEX ZenoTOF™
7600 MS
SCIEX PA 800 Plus
Biologics Analysis System
Waters e2695 HPLC
Proteinsimple Maurice Capillary Electrophoresis
Invitrogen EVOS M5000
Cell Imaging System
Tel: 131 2081 8528
E-mail:CDMO@LKTIME.CN
Addr.:2 Floor, Building 58, 260 Maoyuan Road,
Fengxian District, Shanghai
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