Contract Biotech Manufacturing

Replace spreadsheets with custom application for complex processes

Contract Biotech Development and Manufacturing company (Biotech) needed to replace its use of spreadsheets with an application that better supported collaboration, version control, and its complex process definition and manufacturing processes

  • Custom application accurately reflects scientists’ domain
  • Allows specification of complex biological and chemical processes
  • Supports version control and version comparisons of Bills of Materials
  • Minimum Viable Product delivered in 15 weeks

RoleModel’s team was fantastic to work with from start to finish. Their team drove the solution design and sought to understand our business process so deeply that they were able to suggest improvements. They kept our best interest in mind, treating our money as their own, and responding quickly to feedback. RoleModel Software delivered working software in days, and ultimately exceeded our expectations in translating our spreadsheet heavy process into dynamic software.

Rick Jessee, Director of Operational and Business Excellence, Biotech

Overview

Biotech is a global Contract Development and Manufacturing Organization (CDMO) focused on pharmaceutical manufacturing using cell line development and microbial fermentation. The process development and clinical and commercial manufacturing that Biotech has undertaken for its clients is responsible for producing cell culture solutions, advanced protein expression, gene therapy and viral vaccine products used throughout the world.

Problem

Biotech’s 2020 “paper-to-glass” initiative and its business process re-engineering initiative required a renewed approach to supply chain management through early and thorough identification of materials needed to support its process development and manufacturing. Its existing process was primarily based on the use of shared spreadsheets which presented challenges to smooth collaboration and data version control.

As with many pharmaceutical companies RoleModel has encountered during its history, the use of spreadsheets to manage highly complex work processes is not unusual. What was unusual in this case was Biotech’s willingness to undertake its first-ever software development project in order to replace its use of spreadsheets with a custom application created expressly for Biotech’s process development and management workflow, while at the same time they were redefining and improving the underlying business process.

Solution

Using RoleModel’s approach of producing a “Walking Skeleton” during its 3-week Explore Phase, followed by six 2-week iterations, RoleModel delivered a broad, deep, and, in some aspects, highly complex Minimum Viable Product that was ready for mission-critical production use within days of wrapping up the 15-week effort.

Biotech’s application invites a client to input an initial set of raw materials and formulations needed to produce the desired product (usually a specific molecule). That input is then reviewed by Biotech personnel before Biotech’s process development staff transforms the client’s raw data specification into a reliable, reproducible manufacturing process.

Throughout all phases of this process development, users are restricted to using preferred or approved raw materials with the goal of standardizing the set of materials used and to allow for the timely acquisition of needed materials, thereby decreasing the overall duration of client projects.

Given the exacting requirements of pharmaceutical manufacturing, version control is an important feature of the application. One of the most important outputs of the application is a Bill of Materials (BOM), which can be generated and versioned at several levels of the defined process. When there are multiple versions defined, the application provides a flexible comparison feature that allows comparisons among versions.

RoleModel engaged Biotech’s scientists throughout the software development process, encouraging them to trial the software using data from their actual projects. This engagement led to a highly collaborative and iterative development process, during which the scientists identified many refinements to make the software more valuable and during which RoleModel’s developers became knowledgeable enough of the scientific processes to be fluent in much of the scientists’ terminology, thereby improving all communications.

Results

Satisfaction among Biotech’s management was so high that before the project ended, a set of users from their Supply Chain group was engaged to begin discussing a follow-on project that would use the software’s BOMs as the basis for its procurement processes, allowing another set of spreadsheets to be retired.

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