BioProcess NexusBioProcess NexusTrust The Process

Advanced CMC PlatformEnabling Pharma 4.0

Innovative consulting and software solutions for biopharma professionals. From early-stage characterization through commercial manufacturing, powered by AI agents and GxP-compliant data management.

Explore Solutions

Platform Capabilities

Each module is designed to address real challenges in CMC development, from early-stage characterization through commercial manufacturing.

Supply Forecasting

Live Demo

Monte Carlo simulations and patient-based demand modeling for drug supply risk assessment.

DoE & Characterization

Live Demo

Design of Experiments module with response surface modeling and interactive visualization.

AI Regulatory Co-Pilot

Live Demo

RAG-powered assistant for navigating FDA, EMA, and ICH guidelines with source citations.

Interactive PFD/P&ID Builder

Live Demo

Drag-and-drop bioprocess equipment to create process flow diagrams with AI-powered flow prediction (coming soon).

Document Generation

Coming Soon

Automated batch records and regulatory filing drafts with template-based rendering.

GxP Compliance

Live Demo

21 CFR Part 11 compliant audit trails, electronic signatures, and validation documentation.

The Nexus

Integrating Intelligence, Experience, and Logic

Five pillars connecting deep process expertise with AI-powered tools for compliance and risk reduction.

Design The Process

Characterization, DoE, formulation, and process flow design tools.

Develop The Process

Supply forecasting, analytics, and data-driven scale-up decisions.

Manage The Process

Projects, batches, documents, and experiments in one workspace.

Trust The Process

GxP compliance, audit trails, e-signatures, and Part 11 readiness.

Foster The Process

Expert consulting, technology transfer, and team enablement.

Foster The Process

Engagement Models

Flexible ways to partner, from strategy to full platform delivery.

Advisory Sprint

Architecture + value roadmap in 2-4 weeks.

Learn more

Build & Launch

Ship production-ready modules in 6-12 weeks.

Learn more

Transform & Scale

Continuous optimization and AI enablement.

Learn more
All Services

Built with Modern Stack

Hybrid architecture combining React interactivity with Python scientific computing.

Next.js 14
App Router & Server Actions
FastAPI
Python Scientific Backend
PostgreSQL
GxP Audit Trails
Vercel AI SDK
LLM Integration & RAG