John Miller,Co-FounderDid you know it takes 12-15 years to get a new biologic drug from the research lab to patients? While much of the public focus during that period is on clinical trials, an often-over-looked critical aspect is scaling the development & manufacturing of a biologic from producing a few milliliters to several thousand liters. This involves a high degree of collaboration across a biopharmaceutical company’s global sites and functions, much of which is done manually today.There is plenty of scientific information generated across disparate drug development and manufacturing processes, but what’s missing, according to John Miller, Co-Founder of Fluxa, “is a business-focused solution that connects globally distributed scientists and engineers across key processes, data, and insights”. To streamline development, he adds, “understanding ‘why’ something happened is just as important as ‘what happened’, but often is very difficult to find after the initial insight is generated”. With this in mind, Fluxa has created software products focused on acceleratingthe time-to-marketof new drugs by redefining how biopharmaceutical companies, contract development organizations (CDOs), and contract manufacturing organizations (CMOs) collaborate during the development and manufacturing of drugs.
“Data is the foundation, but integrating it with collaboration and insight management is what drives efficiencies,” says Miller. With a mission to break down barriers within scientific organizations and improve how they communicate with CDOs and CMOs, Fluxa offers a next-generation digital collaboration platform for drug development and manufacturing. Built on the latest digital technologies, Fluxa’s modern, modular applications not only scale to meet clients’ increasing data needs, but also have specific collaboration and insight management capabilities integrated within them.
Fluxa’s ability to leverage a modern technology stack by seamlessly integrating commenting, search, and knowledge management within their business applications allows for rapid information retrieval along with the associated scientific process context. “The key focus is to speed-up processes that currently take months, by facilitating real-time collaboration and knowledge sharing between scientists and engineers as they develop a biologic’s process specification and manufacturing recipe,” explains Suraj Pai, Co- Founder of Fluxa.
Sudheesh Narayanan,Co-Founder and Suraj Pai, Co-FounderThe firm’s flagship, patent-pending product "Scale- UpTM" is the world's first holistic technology transfer & CDMO collaboration tool that runs on one of the most advanced future-proof enterprise technology architectures available in the market today. Deployed on-premise or in the cloud, Scale-Up streamlines technology transfer and enhances knowledge sharing across process development, clinical, and commercial drug manufacturing. Drug manufacturers can use Scale-Up to visually create recipes, manage parameters, build calculations, and perform facility fit in real-time across their global manufacturing network. These companies can then seamlessly partner with CDMOs and sponsors to engage productively, as well as leverage Fluxa’s IoT analytics capabilities to capture discrete and continuous process parameter and quality attribute data.
Fluxa’s IoT analytics platform, Process AnalyticsTM, can pull in manufacturing execution data from multiple sources, such as shop floor sensors, MES, LIMS, Process Historians, etc., to enable multi-source analytics for process monitoring, verification, and analysis. This enables global sites and functions to eliminate manual data-wrangling and streamline analysis and insight generation. Additionally, the manufacturing execution data can be linked back to process specifications managed in Scale-Up to enhance coordination between functions such as process development, clinical, and commercial manufacturing. “Our microservices-based technology stack allows us to integrate communication and collaboration capabilities directly into our business-focused products, considerably increasing customer value,” says Sudheesh Narayanan, Co-Founder of Fluxa.
Fluxa combines the powers of collaboration and data to help Life Science companies and other processes-based manufacturers significantly improve how they operate. With the ability to store insights alongside data, all in the context of the business process being executed, Fluxa’s products are uniquely positioned to redefine process-based industries.