Physicochemical Analysis: Our physicochemical analysis platform is equipped with cutting-edge instruments, including:

⦁ High-performance and ultra-high-performance liquid chromatography (Agilent & Waters)

⦁ Capillary electrophoresis (Sciex)

⦁ Full-column imaging capillary isoelectric focusing electrophoresis (Protein Simple)

⦁ UV-visible spectrophotometer (Thermo)

⦁ Capillary chip Bioanalyzer (Agilent)

⦁ Liquid particle counter (Beckman)

⦁ Turbidity meter (HACH)

The workstation integrates advanced software such as Empower 3, 32 Karat, iCE CFR, and Insight 2, all featuring user authority and multi-level access control to ensure compliance. This platform supports a broad range of analytical capabilities, offering tailored testing services to meet specific client requirements.

Biological Activity Analysis: Our biological activity platform is designed to evaluate potency and mechanism of action (MoA) using assays such as:

⦁ Antibody-dependent cellular cytotoxicity (ADCC)

⦁ Complement-dependent cytotoxicity (CDC)

⦁ Cell proliferation and anti-proliferation assays

⦁ Cell-based enzymatic experiments

⦁ Antibody neutralization and binding activity assessments

With extensive experience in the development, validation, and transfer of methods for mAbs, BsAbs, and recombinant proteins, we also utilize Biolayer Interferometry (BLI) and Surface Plasmon Resonance (SPR) to assess affinity for antigens, C1q, and Fc receptors. Additionally, we provide process-related impurity determination services to ensure comprehensive support for biological activity evaluations.

Characterization Analysis: Our characterization platform features state-of-the-art high-resolution LC-MS technology, enabling:

⦁ Detailed analysis of primary, secondary, and higher-order structures of antibodies, ADCs, and recombinant proteins

⦁ Process-related impurity identification

⦁ Support for IND filings, comparability studies, and product variant and impurity characterization

This robust platform delivers precise analytical insights critical for product development and regulatory compliance.

Three Specialized Laboratories: The Quality Control Department operates through three specialized laboratories: microbiology, physicochemical, and biological activity. Its core responsibilities include:

⦁ Optimization, transfer, qualification, and validation of analytical methods for GMP-related samples

⦁ Batch release and stability testing for intermediates, drug substance (DS), and drug product (DP) in GMP processes

⦁ GMP environmental monitoring and testing for Purified Water (PW), Water for Injection (WFI), clean steam, and System Performance Qualification/Process Monitoring (PQ/PM)

By integrating advanced technologies and adhering to strict GMP standards, our Quality Control Department ensures compliance and supports the production of high-quality biopharmaceutical products.