Innovative Solutions in Biotechnology
Leading advancements in genetic research and development.
Innovative Solutions in Biotechnology
Leading advancements in genetic research and development.
Innovative Biotech Solutions (CRO Services)
Process Development
USP Shake flask DoE: modeled by standard mAb process; USP scaling up or production: modeled by standard mAb; DSP purification; GLP toxicology lot package.
ADC and Bioconjugation
Biologics generation; Linker-payload synthesis; Bioconjugation method development; DoE to optimize process condition; Scaling up
ADC and Bioconjugate analysis
Affinity by Biacore; Cell binding by FACS; Internalization (pH sensitive dye); Cytotoxicity assay (cell killing by ADC or Fab-ZAP); Bystander killing; Aggregation; DAR (LC-MS, HIC); Freeze/thaw; Thermal stability; Serum stability –intact ADC, DAR by affinity capture.
Mass Spectrometry Analysis
LC-MS intact analysis (intact, degly, LC and HC, Fab and Fc); LC-MS Peptide Mapping and PTM; De Novo Sequencing; Immunocapture for LC-MS characterization; UPLC-FLR-MS (N-Glycan); LC-MS quantitation method development for both small and large molecules; LC-MS bioanalysis for plasma, serum, and tissue samples.
Analytical Development
HPLC (SEC, IEX, HIC, RP); CE (CE-SDS or cIEF); SDS-PAGE; Western Blot; DSC and DSF; qPCR and dPCR; ELISA; Biacore; Octet; FACS; Method development, qualification, and validation;
Developability and Formulation Screening
Stability, solubility, formulation studies, and data analysis.