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