Custom Application Development to Replace Spreadsheets for Complex Biological Process Management

An organization in the biotech manufacturing sector relies heavily on shared spreadsheets to manage highly complex biological and chemical process workflows, leading to difficulties in collaboration, version control, and process standardization. This reliance hampers efficient supply chain management, timely material acquisition, and reproducibility of manufacturing processes, affecting overall project timelines and operational efficiency.

A mid-sized Contract Development and Manufacturing Organization specializing in pharmaceutical biotech, focusing on process development and manufacturing of biologics, gene therapies, and viral vaccines, seeking improved collaboration and process standardization.

• Develop a custom application that accurately models complex biological and chemical processes in line with scientific domain requirements.
• Enable precise input, review, and transformation of raw material and formulation data into reliable, reproducible manufacturing processes.
• Implement robust version control features with comparison capabilities for Bills of Materials across process iterations.
• Support standardization of raw materials and formulations to streamline procurement and reduce project lead times.
• Deliver a minimum viable product within 15 weeks that is suitable for mission-critical use.
• Facilitate early collaboration with scientists for iterative refinement and validation of the software.

• Input module for initial raw material and formulation data.
• Workflow transformation tool enabling scientists to convert raw data into validated manufacturing processes.
• Version control system for Bills of Materials with history tracking.
• Comparison engine for analyzing differences between process versions.
• Material standardization enforcement to ensure only preferred/approved raw materials are used.
• User access controls to restrict modification rights during different process phases.
• Collaborative review interface for iterative process refinement.

• Laboratory information management systems (LIMS) for raw material data.
• Procurement systems for material ordering and inventory management.
• Data repositories holding scientific process data.

• System availability of 99.9% uptime.
• Data security compliant with regulatory standards (e.g., HIPAA, GDPR).
• Scalable architecture supporting increasing data complexity and user base.
• Responsive interface optimized for usability across devices.

The implementation of this custom process management application is expected to significantly improve collaboration among process development staff, reduce project lead times by standardizing procedures and materials, and enhance process reproducibility. The system aims to enable rapid iteration and validation, leading to higher quality outputs. By replacing manual spreadsheet management, the organization can attain greater data accuracy, control, and regulatory compliance, ultimately supporting faster client project turnaround and scaled manufacturing operations.