Recently, adalimumab injection (brand name: Shengainin^®), independently developed by Wuhan Institute of Biological Products, China National Biotec Group, has been approved for marketing by the National Medical Products Administration (NMPA). It marks the first domestically developed and production-approved fully human monoclonal antibody drug in Hubei Province.

As the quality control technical partner for this project, HZSKBIO^® provided antibody coverage verification services for Shengainin^®. The company accurately analyzed the recognition capacity of host cell protein (HCP) antibodies and guaranteed the validity of experiments through full-process quality control. This supported the safety and compliance of the drug’s production process and accelerated its clinical translation.

Given the diversity and complexity of HCP compositions, adequate characterization of corresponding HCP antibodies is required prior to using commercial or customized ELISA kits.

For HCP samples derived from CHO, E. coli, Vero, Hansenula polymorpha and other cell strains, HZSKBIO^® offers the 2D-WB method for evaluating antibody coverage. Meanwhile, the company has independently developed proprietary HCP immunomagnetic bead affinity separation technology, paired with two analytical approaches: 2D gel electrophoresis or LC-MS.

The successful launch of Shengainin^® has earned high recognition for HZSKBIO^®’s technical strength and service quality. HZSKBIO^® will further deepen its collaboration with Wuhan Institute of Biological Products, advancing biopharmaceutical R&D from "compliant approval" to "high efficiency and superior quality". Together, both parties will empower quality upgrading and product breakthroughs within China’s biopharmaceutical industry.

Shengainin^®: Cherish Life, Safeguard Health

Developed on the mature antibody drug development platform of Wuhan Institute of Biological Products, Shengainin^® adopts disposable bioreactors for high-density culture of engineered cells. Advanced platform purification processes are applied to efficiently remove impurities and deliver high product purity. Adhering to stricter process specifications and quality standards, it provides patients with premium adalimumab therapy.

HZSKBIO^® HCP Residue Testing & Analysis Platform Accelerates Rapid Drug Translation

1. HCP Testing Reagents

HZSKBIO^® devotes itself to developing commercial HCP test kits that closely mimic real production processes. Through differential analysis of HCPs across diverse manufacturing workflows, the company delivers customized HCP test kits tailored to segmented process sectors.

2. Customized HCP Development Services

HZSKBIO^® owns an end-to-end independent development platform covering antibody characterization, immunization strategies, antibody production, system development, and regulatory-compliant development and validation. All workflows comply with the CNAS quality assurance system and meet audit requirements.

3. HCP Antibody Coverage Assessment

Leveraging immune affinity capture technology and the advantages of magnetic beads, HZSKBIO^® has developed proprietary HCP immunomagnetic bead affinity separation technology integrated with two analytical workflows (2D electrophoresis or LC-MS). This system evaluates the matching degree between polyclonal antibodies used for HCP detection and target HCPs. Self-developed quality controls are embedded throughout all testing stages, with full method validation to ensure reliable experimental results.