Proxima

Proxima (Basic Design & Eval) is a process modeling software suite developed by Ypso-Facto, aimed at engineers and decision-makers working on biologics manufacturing. It enables teams to model complete bioprocesses — covering both upstream and downstream unit operations — within a single flowsheet environment, and to evaluate those processes against economic and environmental metrics.

A core challenge in bioprocess development is that upstream and downstream steps are typically optimized in isolation, making it difficult to identify true performance levers across the full process. As the number of unit operations increases, whole-process modeling becomes complex. Proxima addresses this by providing simplified yet structured process descriptions that do not require specialized modeling expertise, allowing engineers to perform in-silico analysis and scenario comparison at the full-process level.

Key Challenges Addressed

• Evaluating whether investment in multi-column chromatography systems is justified
• Assessing whether additional assets are needed or whether better equipment occupancy and bottleneck management can meet capacity requirements
• Identifying levers to reduce the environmental impact of a bioprocess
• Comparing processes across manufacturing locations where raw material prices, labor, and energy costs differ
• Determining the main cost drivers and prioritizing improvement efforts

Software Capabilities — Basic Design & Eval Apps

• Basic Design provides flowsheet representations of complete bioprocesses, including mass and heat balance calculations across upstream, downstream, and auxiliary steps
• Eval translates flowsheet data into economic and environmental metrics, including PMI, E-Factor, and CO2 equivalents
• Supports batch processes, continuous processes, and combinations of both, with no inherent process-type limitations
• Allows users to create high-level and detailed process diagrams using functional blocks and equipment types
• Flowsheets, mass balances, and cost evaluations can be refined iteratively over the lifecycle of a process
• Supports integration of user-supplied cost data, enabling tailored cost-of-goods calculations and standardized comparisons across projects and teams
• Covers the full process from bioreactor production through downstream purification in a single unified view

Engagement Models

• Software license (Basic Design & Eval): Teams obtain a license to model and evaluate bioprocesses in-house, with optional support packages available to accelerate onboarding
• Collaborative partnership (Extended team): Ypso-Facto works alongside internal scientists and engineers to structure data from diverse sources, test scenarios, and identify relevant process levers, acting as an extension of the client team
• Independent assessment (External advice): Clients share process data and scenarios with Ypso-Facto, who then deliver a third-party evaluation using Basic Design and Eval, providing unbiased answers to specific process questions such as whether continuous chromatography or single-use technologies are appropriate

Case Study: mAb Purification Process Comparison (in collaboration with Sanofi)

• The study compared the classical monoclonal antibody (mAb) purification process with Sanofi's EASY process, which operates in full flowthrough mode using single-use technology
• Both processes were represented as flowsheets in the Basic Design application of Proxima
• Cost evaluation was performed using the Eval application, comparing both processes on a per-batch basis
• Results showed that the EASY process enables a significant cost reduction, with the advantage being more pronounced for a smaller number of batches
• The case study demonstrates Proxima's capability to perform high-level cost comparisons between different process options

Proxima is offered by Ypso-Facto, a firm combining expertise in chemistry, biotechnology, and process engineering. The platform is designed to support in-house capability building as well as collaborative or externally managed evaluations, and is applicable across the development lifecycle from early design through process optimization.