HJB has advanced analytical equipment, which can provide analytical services that meet the requirements of FDA / NMPA regulations. The analytical services include development and optimization of analytical methods for monoclonal antibodies, bispecific antibodies and fusion proteins; characterization studies; in-process control sample testing; method transfer and qualification; DS and DP release testing; as well as establishing specifications for process and DS / DP for IND / BLA application
Release Test Methods Services: HJB can develop release methods of all biopharmaceutical products for customers. If the client can provide a release method and transfer to HJB, according to the maturity of the method, the client method will be either transferred directly to HJB QC or transferred to HJB AS. The method which is transferred to AS will be further optimized and then the method will be transferred from AS to QC internally for qualification. Some method developments for new project are based on platform technology. The developed method will be applied to the detection of in-process control, DS and DP (including identity, purity, impurity, concentration, potency and other quality attributes).
Protein Characterization Services: Protein characterization services include molecular weight, PTM, glycosylation analysis, sequence coverage, N-, C-terminal confirmation, disulfide bond confirmation, glycan profile, isoelectric point, free sulfhydryl group, Fc function, DLS, DSC, extinction coefficient and affinity. The Fc functional characterization includes FcRn, FcγRI, RcγRIIa, RcγRIIIa and C1q. Affinity characterization includes antigen and antibody affinity measured by SPR.
Analytical Method Transfer, Qualification & Validation: After the method development is completed, all parameters will be locked and ready for transfer. Method transfer procedure is used to guide the entire process of method transfer, define its objective/scope, related materials/instruments, acceptance criteria and data analysis procedure.
For the analytical method used for release testing / stability studies and in-process control (IPC), we provide comprehensive strategic plan for their qualification / validation. Our methods and procedures strictly evaluate the following parameters: accuracy, repeatability, intermediate precision, specificity, stability indication, limit of quantitation (LOQ) and robustness. After the qualification / validation is successful, the analytical method is deemed suitable for its intended use.
The Analytical Science department has numerous HPLC, UPLC, PA800, cIEF, capillary electrophoresis instruments, and UPLC/CE-Mass spectrometer, Microplate Reader, qPCR, Biacore, UV-Vis spectrophotometer, and is capable of performing general and advanced analytical needs.