Chime Biologics Electronic Contract System (e-Sign) Project

I. Case Overview

Chime (Wuhan) Biopharmaceutical Co., Ltd., established on June 19, 2013, is a Wuhan-based CDMO (Contract Development and Manufacturing Organization) dedicated to client-centric, time-efficient, cost-effective, and high-quality biopharmaceutical solutions. With advanced production facilities spanning 150,000 square feet in Wuhan’s Biolake Biotechnology Industry Development Zone (Optics Valley of China), Chime Biologics operates the world’s first GE KuBio plant, renowned for its water and energy efficiency. The site features four 2,000L and two 500L single-use bioreactors for clinical and commercial GMP production, with total capacity expanding to over 140,000L by 2024. As a global leader in biopharmaceutical CDMO services, Chime offers fully integrated solutions for monoclonal antibodies, bispecific antibodies, fusion proteins, and enzymes, ensuring robust, cost-effective production from early development to late-stage clinical and commercial GMP manufacturing.

II. Project Background

To leverage digital innovation for enhanced management, data integrity, and traceability, Chime Biologics implemented the Hippocrates SignTrust® e-Contract System (eSign), transitioning from manual paper-based signing to digital workflows. This initiative addresses inefficiencies in offline document processing, reduces compliance risks, and aligns with industry regulations.

III. Implementation Approach

A. Holistic Planning

SignTrust® streamlines contract lifecycle management via automated workflows, offering organizational management, seal authorization, CA certification, digital signatures, timestamping, contract validation, real-name/SMS authentication, facial recognition, enterprise directories, e-document storage, and business intelligence. Full automation accelerates operations, strengthens compliance, and enhances user experience.

B. Organizational Management

eSign supports multi-tiered and parallel organizational structures, enabling cross-entity contract distribution (B2B and B2C) with granular 权限管理. Companies can customize seal management policies based on operational needs.

C. Integrated e-Signing Solution

The system provides a unified platform for e-signing + data forensics + physical seal control + anti-counterfeit printing. Centralized seal management ensures secure, compliant usage through role-based access controls, optimizing efficiency and legal adherence.

D. Technical Architecture

SignTrust® e-Contract System is a core module of Xingdi’s Aotai Digital Platform, a quality-compliance-focused ecosystem co-developed by industry and IT experts. Aotai’s modular design allows customizable quality systems without coding, featuring pre-built tools for forms, decision trees, and dashboards. Key technical strengths include:

• Distributed architecture for scalable data storage and rapid access.
• Smart loading and caching for optimized performance.
• Standard APIs enabling seamless integration with ERP, MES, and third-party systems.
• Automated alerts (email/SMS) and audit trails to minimize approval delays.

IV. Project Outcomes

A. Organizational Impact

1. Operational Efficiency50% reduction in data collection time.80% faster contract generation.60% fewer management hours.95% shorter signing cycles for multi-party/remote agreements.
2. Data Management100% data consistency and accuracy.Paperless workflows cutting printing/archiving costs by 70%.
3. Compliance & SecurityAdherence to FDA 21 CFR Part 11 and CA certification standards.Immutable audit trails for regulatory inspections.
4. Process OptimizationEnd-to-end digitalization from drafting to archiving.Cross-departmental collaboration via real-time data sharing.

B. Societal Impact

1. Industry ComplianceLegal validity of e-signatures under China’s Electronic Signature Law.Enhanced data integrity and dispute resolution through timestamping and digital certificates.
2. Sustainable PracticesReduced reliance on paper and logistics, aligning with green initiatives.
3. Innovation LeadershipSetting a benchmark for digital transformation in biopharma CDMOs.Enabling agile responses to crises (e.g., pandemic-driven remote operations).

V. Future Directions

Chime Biologics aims to further enhance Aotai’s capabilities through:

• Advanced analytics for predictive maintenance and risk 预警.
• Deep integration with MES/ERP systems for end-to-end supply chain optimization.
• Continuous compliance upgrades to meet evolving global standards.
• By prioritizing digital innovation, Chime Biologics not only strengthens its competitive edge but also provides a replicable model for the biopharma industry’s 智能化转型.
• Key References:

• 21 CFR Part 11 (FDA regulations on electronic records/signatures)
• China’s Electronic Signature Law (2005)
• Biolake Biotechnology Industry Development Zone official documentation
• Chime Biologics partnership with Humanigen for COVID-19 antibody production