HJB - Your Trusted Biologics CDMO Partner

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HJB - Your Trusted Biologics CDMO Partner

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Quality Control

The quality control department of HJB provides comprehensive quality control methods and strategies for recombinant protein, monoclonal antibody and other biological products to support their clinical and commercial GMP production.

Relying on excellent and stable performance equipment, our team is building an integrated quality control platform covering all analysis services

We have a comprehensive GLP / GMP quality system and carry out quality control activities and stability projects in accordance with the guidance of NMPA, FDA, EMA and ICH

Our laboratory information management system (LIMS) ensures that our records and results are reliable and traceable (in accordance with 21 CFR Part 11).

Responsibility and Scope

• Analytical method optimization, transfer, qualification & validation

• In-process control, DS & DP release testing

• DS and DP stability studies

• Environmental monitoring and PW, WFI, Clean Steam testing

• Raw material, excipients and primary package release testing

• GMP manufacturing Commissioning, Qualification and Validation testing support

Biologics Release Methods

  • Identity: • Peptide mapping

    • pI values (icIEF) / CEX-HPLC

  • Purity: • HMW and LMW testing

    SEC-HPLC and CE-SDS R/NR

    • Charge variants

    CEX-HPLC or icIEF

  • Potency: • Binding assay (ELISA)

    • Cell-based assay

  • Safety: • Residual Host Cell Protein (HCP)

    • Residual Protein-A ELISA

    • Residual Host Cell DNA

    • Sterility

    • Endotoxin

    • Bioburden

  • General Testing: • Appearance and color

    • Clarity

    • Protein concentration

    • pH

    • Osmolality

    • Extractable volume

    • Invisible particles

    • Visible foreign objects

Stability Study

• High quality LIMS sample management system

• Procedures for stability studies under long-term, accelerated and stress conditions

• Stability samples testing

• Stability study report for each time point

• Both DS and DP comply with the requirements of ICH Q1A-Q1F

• Stability room with real-time alarm system and real-time temperature and humidity monitoring system

• Data-driven trend analysis

Case Study

SERVICES