Release Test Methods Services: HJB can develop release methods of various 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 if necessary 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).

Table 1. Example of Non-compendial Release Methods of Antibody Products

Protein Characterization Services: Protein characterization services include molecular weight, PTM, glycosylation analysis, sequence coverage, N-, C-terminal sequencing, disulfide bond confirmation, glycan profile, isoelectric point, free sulfhydryl group, DLS, DSC, extinction coefficient and affinity. The affinity characterization includes FcRn, FcγRI, RcγRIIa, RcγRIIIa, C1q, antigen and antibody affinity.

Table 2. Protein Characterization Services Overview

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, linearity, precision, specificity, stability indicating, limit of quantitation (LOQ) and robustness. After the qualification / validation is successful, the analytical method is deemed suitable for its intended use.