Enhancing Data Integrity and Accessibility for Antibody Medicine Development with AWS Data Lake

Context and Challenge

A global biotechnology company specializing in antibody therapeutics for cancer treatment faced critical data challenges that threatened their operational efficiency and regulatory compliance:

1. Lack of Standardization: Disparate data management practices created inconsistencies and inefficiencies.
2. Compliance Risks: Regulatory requirements, including GxP and GDPR, highlighted vulnerabilities in their data security and integrity.
3. Data Access Issues: Limited data democratization hindered organizational decision-making and collaboration.
4. Operational Costs: High maintenance and compliance costs strained resources.

USDM Solution

USDM partnered with the biotechnology company to design and implement a secure, compliant, and scalable data platform using AWS services. The solution featured:

1. AWS S3 and Lake Formation:
   • Centralized all structured and unstructured data to provide a single source of truth.
   • Enabled advanced data mining and unstructured data analysis for data scientists.
2. Validated Architecture:
   • Designed a GxP and GDPR-compliant platform to ensure data security and integrity.
   • Automated workflows for consistent data governance and compliance reporting.
3. Built-In Security:
   • Integrated robust encryption, access controls, and audit trails to safeguard clinical trial and biomarker data.
4. Cost Optimization:
   • Reduced maintenance, security, and compliance costs through cloud-based automation and scalable architecture.

Quantified Outcomes and Business Impact

1. Compliance and Risk Management:
   • Achieved 100% GxP and GDPR compliance, reducing audit and inspection risks.
   • Improved regulatory transparency with automated compliance features.
2. Operational Efficiency:
   • Streamlined data management processes, reducing manual efforts by 30%.
   • Accelerated data access and analysis by 50%, enhancing decision-making speed.
3. Cost Savings:
   • Lowered maintenance and compliance costs by an estimated 25%, saving approximately $150,000 annually.
4. Data Accessibility and Insights:
   • Established a single source of truth, enabling consistent and reliable insights for data-driven decisions.
   • Democratized data access across the organization, improving collaboration and innovation.

Strategic Takeaways

The GxP and GDPR-compliant platform built by USDM transformed the biotechnology company’s data management practices. By leveraging AWS services, the organization gained enhanced data integrity, accessibility, and regulatory compliance. This case demonstrates how modern cloud solutions can reduce costs, improve transparency, and enable innovation in the highly regulated biotechnology sector.