Monoclonal Antibody Development and Production Service

Monoclonal antibodies (mAbs) have become essential tools for developing treatments for cancer, autoimmune diseases, infectious diseases, and diagnostic reagents, owing to their high specificity, targeting ability, and engineering potential. In 2023, the global market reached over $230 billion, yet the industry still faces challenges such as target homogeneity, complex processes, and insufficient CMC capabilities. With over 15 years of experience, Creative Biogene offers a full-service solution from antigen design to GMP production, helping clients overcome technological bottlenecks and seize market opportunities.

Core Service Modules

1. Antibody Discovery and Engineering

Comprehensive Technology Platforms

Figure 1. Architecture of common BsAbs formats.

Humanization and Functional Optimization
CDR grafting + affinity maturation to reduce immunogenicity, supporting bispecific antibodies (BsAb) and antibody-drug conjugates (ADC) development.

2. Process Development and Scalable Production

Cell Line Development: CRISPR gene-edited CHO/HEK293 cell lines, achieving antibody expression levels of 8-12 g/L (industry average 5-8 g/L), reducing production costs by 30%.
Continuous Flow Production System: Utilizing continuous flow chromatography technology, reducing resin consumption by 60%, and tripling single-batch processing capacity to support kilogram-scale orders.
ADC Drug Conjugation: Exclusive pH-sensitive antibody designs enable tumor microenvironment-specific activation, improving toxin release precision by 50%.

3. Quality Control and Compliance Support

Multidimensional Characterization Techniques: HDX-MS epitope mapping, SPR affinity testing and forced degradation tests (thermal stability ≥40°C) to ensure antibody consistency and functionality.
Dual Standard Delivery System: Both R&D-grade (ISO 9001) and clinical-grade (GMP) processes in parallel, supporting dual filing preparations for US and global markets, with endotoxin levels<0.1 EU/mg.

Figure 1. One-stop antibody discovery and engineering flowchart.

Industry Pain Points and Solutions

Client Pain Points	Our Advantages
Low success rate for membrane protein targets (<40%)	Liposome-recombinant antigen technology, success rate 70%
Long production cycle (traditional 12-16 weeks)	AI pre-screening + expedited project channels, 6-week fast delivery
Low production capacity utilization	Flexible gradient production (1 mg – 1 kg), idle capacity converted to CDMO services
Intense competition in homogenous targets	Differentiated target development (GPCRs, ion channels) + combination therapy design

Service Process

Requirement Analysis: Submit target information (FASTA sequence/structure file) → Free antigen epitope pre-evaluation.
Customized Plan: Our technical team will provide development strategies and a quotation (including milestone-based payment options) within 48 hours.
Project Execution: Real-time online progress tracking, and key milestone video reports (e.g., positive clone screening, SPR validation).
Delivery & Support: Antibody samples + complete data package (including HDX-MS maps, QC certificates) + technical transfer services.

Certifications and Guarantees

Production Capacity Guarantee: 4 × 2,000L bioreactors, dedicated ADC production lines, -80°C cold chain with global delivery.
Intellectual Property Protection: NDA confidentiality agreements + independent production lines, preventing cross-contamination risks.
Risk Control: Milestone-based payment structure, free pre-evaluations to reduce early-stage trial and error costs.

Creative Biogene is committed to driving innovation in monoclonal antibody development and production. We provide integrated solutions that address industry challenges, ensure high-quality output, and streamline the path to commercialization. Contact us today to explore how we can accelerate your antibody drug development and help you succeed in the competitive global market.

* For research use only. Not intended for any clinical use.

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