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Bispecific antibodies (BsAbs) represent a groundbreaking advancement in antibody engineering, enabling simultaneous targeting of two distinct antigens or epitopes. As of 2024, 15 BsAb drugs have been approved globally for indications including solid tumors, hemophilia, and ophthalmic diseases, with over 160 candidates in clinical trials (accounting for 20% of the global antibody pipeline). This underscores the immense potential of BsAbs in transforming therapeutic strategies.
BsAbs are engineered to act as molecular "bridges," connecting immune cells (e.g., T cells) to tumor cells for targeted cytotoxicity or modulating dual signaling pathways to amplify therapeutic effects. Based on Fc domain retention, BsAbs are classified into two categories:
IgG-like BsAbs: Retain Fc-mediated effector functions (ADCC/CDC) with an extended half-life (7-21 days).
Non-IgG-like BsAbs: Compact design for enhanced tissue penetration, albeit with a shorter half-life (<24 hours).
Creative Biogene leverages a mature R&D system and innovative technology platform to offer comprehensive solutions, from target design to commercial production, addressing the three key challenges in bispecific antibody development.
Challenge: Random heavy-light chain pairing generates >80% non-functional antibodies, complicating purification and compromising activity.
Creative Biogene has pioneered multiple state-of-the-art antibody engineering platforms:
Figure 1. Architecture of common BsAbs formats.
Challenge: Unoptimized BsAbs exhibit high aggregation rates (>10%) and short serum half-lives (<24 hours), limiting efficacy and dosing convenience.
Creative Biogene optimizes both structure and function:
Flexible linkers (e.g., (G4S)3): Reduce steric hindrance and balance dual-target binding kinetics (aggregation rate<3%).
Rigid linkers (e.g., α-helix): Improve thermal stability (Tm >70°C) for robust storage and handling.
Fc Optimization: pH-dependent modifications extend serum half-life to 120 hours, reducing dosing frequency.
Challenge: Traditional workflows require more than 18 months for process development, with high failure rates and poor batch consistency (RSD >20%).
Creative Biogene has developed modular production solutions:
Engineered Cell Lines: Pre-integrated high-expression sites in CHO cells shorten cell line development to 8 weeks.
Bicistronic Vectors: Ensure equimolar heavy-light chain expression, achieving stable titers of 5-8 g/L.
Standardized Purification: Three-step chromatography (Protein A → CEX → SEC) with platform parameters scalable from 50L to 2000L, ensuring batch-to-batch consistency (RSD<10%).
Pre-Validated Viral Clearance: Nanofiltration (20 nm) + low-pH incubation achieves LRV >4, directly supporting IND submissions.
| Stage | Deliverables | Timeline |
| BsAbs Design | Epitope conflict analysis, 3D molecular model | 4-8 weeks |
| Cell Line Development | High-titer cell lines, process parameters | 6-8 weeks |
| GMP-like Production | Toxicology batches (1-5 g), CMC documentation | 12-16 weeks |
| Process Validation | Batch records, stability data | 12-16 weeks |
Success Rate Guaranteed: 15+ years of expertise with >95% project success rate.
Cost Efficiency: Platform-based workflows reduce development costs by 30-50%.
Risk Mitigation: Free feasibility analysis to de-risk early-stage development.
The global BsAb market is projected to grow at a 35% CAGR, reaching $50 billion by 2030. Creative Biogene will continue to drive technological innovation through smart production platforms (e.g., AI-driven molecular design) and a global production capacity network, empowering partners to accelerate breakthroughs in oncology, neurodegenerative diseases, and other unmet clinical needs.
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