For Existing Processes

Industrial chemical plant with large metal pipes, yellow safety railings, and blue sky.

    • Process Development & Scale-Up – production of process description & flow diagrams (PFDs), an overview of process steps, media, key parameters, and control strategy.

    • Scale-up Strategy Report - identification of scale-up criteria (kLa, dissolved gas concentrations, ramp up strategy & timings, etc.) including any correlations used and rationale

    • Mass and Energy Balances - calculations at pilot and industrial scale.

    • Critical Parameter Identification (CPPs & CQAs) - definition of key process variables and their impact on product quality.

    • Risk & Sensitivity Analysis - identification of risks during scaling (oxygen limitation, heat removal, shear stress…).

    • Process Optimization Report - summary of lab/pilot runs with data analysis and recommendations for industrial implementation.

    • Tech Transfer Package / Dossier summarizing: process description, SOPs, analytical methods, critical control points, equipment requirements

    • URS (User Requirement Specification) - document defining the functional and performance requirements for new equipment or facilities.

    • P&ID (Piping and Instrumentation Diagram), PFD & Sequence Logic Review – review of diagrams/documentation from engineering design houses in terms of fit-for-use for the process.

    • Equipment Specification Sheets - recommended reactor volumes, agitation, aeration, control loops, cleaning strategy, etc.

    • Facility Fit Assessment - compatibility of client’s site with process requirements (utilities, layout, CIP/SIP).

    • Process Modelling / Simulation Report - using Matlab.

    • Stoichiometric Models - mathematical models for prediction of yield, productivity, etc.

    • DoE (Design of Experiments) Summary - experimental plan, results, and statistical conclusions.

    • Data Summary and Descriptive Statistics – statistical summary reports, batch summary table/dashboards, trend analysis charts.

    • Process Capability & Variability Analysis – process capability reports, control charts, Anova or variance decomposition analysis.

    • Correlation & Root Cause Analysis – correlation matrices/regression models, cause-and-effect summary or pareto analysis.

    • Decision Support and Communication – final statistical summary presentation/dashboard, recommendation report, validation or continuous improvement summary.

    • Feasibility Study Report - technical and economic viability assessment.

    • Scale-up Roadmap / Development Plan - from lab to pilot to industrial milestones.

    • Vendor & Partner Recommendations - list of potential equipment or CDMO partners.

    • Training & Workshops - tailored sessions for client teams (e.g. scale-up fundamentals, bioreactor operation, process training, etc.).

    • Fractional Head of Bioprocess support

    • Fermentation operations and scale-up training

    • DoE implementation for ongoing R & D framework

Our Services

Technical Due Diligence

Workers in safety gear and helmets inspecting and working on industrial pipes and equipment at an industrial plant or refinery.

  • Process robustness matrix, identifying critical process parameters (CPPs) and risk factors.

  • Scale-up performance assessment and readiness score (e.g., TRL 4–7).

  • Upstream–downstream integration risk overview.

  • Benchmarking report with gap analysis.

  • Techno-economic analysis/models to validate that fermentation performance is sufficient to meet cost targets.

  • Assess physical assets and operational practices relevant to fermentation.

  • Includes:

    • Executive summary with key findings and go/no-go recommendation.

    • Technical deep-dive with data visuals and risk maps.

    • Benchmarking vs. industry and comparable processes.

    • Recommended next steps (R&D focus, pilot campaigns, data to collect before investment).

Our Services