Bioprocess Digital Twin & Predictive Analytics

1. Executive Summary

In high-stakes biomanufacturing, telemetry data is often siloed in static logs, leading to a reactive operational posture where deviations are discovered only post-batch. This gap creates significant risk for high-value pharmaceutical yields.

I developed the Bioprocess Insight Platform (BIP): a containerized, AI-augmented Triad Microservice Architecture designed to serve as a high-fidelity Digital Twin for Sartorius Biostat® fermentation systems. Unlike a simple dashboard, BIP integrates three distinct layers:

• Real-time SCADA Simulation: A high-frequency FastAPI engine that streams multivariate sensor data and calculates physics-based projections ($OTR/k_{L}a$).

• Regulatory Compliance: A dedicated .NET/Docker microservice that ensures 21 CFR Part 11 data integrity through an immutable GxP audit trail.

• Industrial HMI: A reactive TypeScript dashboard that translates raw telemetry into predictive "Batch Health" scores.

By architecting this polyglot solution, I have demonstrated a production-ready approach to transforming raw process data into a proactive, observable, and compliant digital twin.

What's New in V2

• AI Pilot (Closed-Loop Control): A reactive layer that automatically restores Dissolved Oxygen levels by adjusting impeller speeds, demonstrating autonomous deviation recovery.

• Unique Batch Tracking: Implementation of a persistent Batch ID system (e.g., B2026-001) to isolate and identify distinct production runs for historical analysis.

• E-Signature Verification: Role-based digital signatures (Lead Scientist, Lab Tech, QA) for all critical actions, ensuring strict adherence to 21 CFR Part 11.

All code, is version-controlled and fully documented.

👉 Launch Live Dashboard    |  Audit API  |  Explore Source Code on GitHub    |    Interactive API Docs (Swagger)

2. Business & Operational Impact

The implementation of the Bioprocess Insight Platform (BIP) directly addresses the high-risk nature of pharmaceutical manufacturing by replacing reactive monitoring with proactive intelligence.

1. Risk Mitigation & Yield Protection

By utilizing the AI Pilot and Digital Twin projections, the system can anticipate a thermal or oxygen-related deviation up to 60 seconds before it occurs. In a production environment, this translates to saving batches worth hundreds of thousands of dollars that would otherwise be lost to process excursions.

2. Regulatory Readiness (GxP)

The platform is engineered with a "Compliance-First" mindset. By automating the Audit Trail via a dedicated .NET microservice, the system ensures that every operator interaction is recorded in a 21 CFR Part 11 compliant format, significantly reducing the time required for QA review and regulatory filing.

3. Operational Efficiency

The Industrial HMI simplifies multivariate data. By translating complex sensor telemetry into a single Batch Health Score, operators can manage multiple bioreactors simultaneously with high-fidelity "At-a-Glance" observability, reducing the cognitive load and potential for human error.

4. Technical Scalability

The Triad Microservice Architecture ensures that the system is not a monolith. The Data Engine, Compliance Service, and HMI can be scaled independently, allowing the platform to grow from a single R&D lab to an enterprise-wide manufacturing execution system (MES).

6. GxP Compliance & Data Integrity (21 CFR Part 11) 

In biopharmaceutical manufacturing, data integrity isn't just a best practice—it’s a legal mandate. I engineered a dedicated .NET Audit Microservice to serve as the platform’s "Compliance" backbone, ensuring every interaction meets rigorous 21 CFR Part 11 standards through the following features:

• Role-Based E-Signatures: To ensure accountability, critical actions are digitally signed and bound to specific organizational roles (e.g., "Lead Scientist"). This prevents generic "Admin" overrides and ensures a clear chain of custody.

• Immutable Logging & Synchronous Hooks: Every setpoint change (e.g., adjusting Impeller RPM) within the Digital Twin is paired with a concurrent, non-repudiable log entry. These synchronous hooks ensure that a change cannot be committed to the process without a successful write to the audit database.

• Polyglot Coordination: This demonstrates a complex "Golden Record" architecture. A single user action in the React HMI is verified across two distinct backend environments—Python for process logic and .NET for compliance—guaranteeing data consistency across the entire batch lifecycle.

• 21 CFR Part 11 Exports: A dedicated reporting engine generates "verified receipts" in CSV format. These exports provide a tamper-evident audit trail of all interactions, ready for immediate regulatory submission during audits.