Drug Substance Analytical Development and Validation

Ø Variable assays and impurities analysis using HPLC, UPLC, MS, biological activity method.

Ø Method development and validation based on specificity, accuracy, linearity, range, precision, LOD, LOQ, in accordance with ICH, USP and ChP.

Ø Comprehensive characterization using LC-MS and LC-MS/MS methods, such as intact and reducing MS, glycan profiling, disulfide bond, oxidation, deamidation, N- and C-terminal heterogeneity, charge variants, size aggregation and fragmentation.

Ø Analysis using different combination of RPC, IEX, SEC, LC-MS, CE, cIEF and high throughput chip-based technology.

Ø Analytical support for process development and trouble-shooting, In-process control and release testing.

Ø Specific analysis for residual solvents, endotoxin, process related impurities such as host cell DNA and host cell protein and leached protein A

Drug Product Analytical Development and Validation

Ø Formulation analysis using stability evaluation method for formal stability and stressed stability.

Ø Combination of different method such as UV, fluorescence and CAD for the content assay of different excipients, raw materials and residues.

Ø Aseptic filling sterile product release testing and stability-indicating assay in accordance to ICH and China regulation.

Developability Assessment

Ø Risk-based forward-looking analytical service using different state-of-art technologies to avoid the CMC development risk. This service is dedicated to increase the clinical success rate for biotech drugs.

Ø Different test samples from different development stages are qualified for this service, such as transient expression, monoclonal selection, in-process sample or drug substance.

Structure Elucidation, Characterization and Impurity

Ø High accuracy LC-QTOF-MS and LC-MS/MS as the state-of-art technique platform.

Ø Multi-level LC-MS glycosylation profiling and quantification for the released glycans and glycopeptide.

Ø In-depth characterization of glycosylation, including the positioning, total profiling, site-specific identification and quantification, assay of sialic acid (NANA and NGNA).

Ø Higher-order elucidation by DLS, Tm, Tagg, IR, CD, UV, and the other labeled or label-free methods.

Ø Size and charge isoforms isolation and verification for comprehensive analysis of product attributes.

Reference Standard

Ø Full characterization with chromatographic purity, protein content assay, LC-MS/MS, biological activity, stability, etc.

Ø Establishment of two-tiered system for the management of reference materials.

Ø Qualified storage, pre-use and in-use management, and re-qualification study.

Stability research

Ø Different stability conditions including 2-8℃, -20℃, -80℃, freeze cycling, 40℃/75%RH, 25℃/60%RH, and customized conditions.

Ø Validated stability-indicating assay in accordance with guidelines.

Ø Stability storage was qualified, calibrated and maintained.

Ø Access control, real-time temperature and humidity monitoring with alarm system.