Fermentation & Scale-Up

A flexible path from process transfer to commercial production.

Scale-Up Starts With Understanding the Process

Moving a microbial process from the laboratory into manufacturing requires more than increasing vessel volume. Mixing, oxygen transfer, heat removal, feed strategy, raw-material variability, sampling, harvest timing and downstream behavior can all change as scale increases.

Wisconsin BioProducts works with customer technical teams to fully understand the process, identify the variables most likely to affect scale-up, and develop a practical manufacturing plan before larger production commitments are made.

Technology Transfer & Process Review

• Review all available process descriptions, batch records, and development data
• Identify critical process parameters and critical quality attributes
• Evaluate raw materials, media and feed preparation requirements
• Review seed-train strategy and inoculation requirements
• Define sampling, testing, and acceptance criteria
• Identify scale-dependent technical and operational risks
• Establish project responsibilities, documentation and milestones

Engineering & Pilot Runs

Engineering and pilot production runs provide an opportunity to observe how a process behaves outside the laboratory and to generate the most accurate information needed for commercial planning.

Where appropriate, WBP can use staged runs to evaluate process performance, refine batch documentation, address scale-dependent behavior and reduce risk before full commercial production.

• Evaluate mixing and oxygen transfer behavior
• Confirm feed and addition strategies
• Assess fermentation duration and harvest timing
• Evaluate recovery and downstream throughput
• Refine sampling and in-process controls
• Generate material for customer evaluation for further testing

Commercial Fermentation

Once the process and production strategy are defined, WBP can support repeat commercial manufacturing with a focus on consistency, communication and practical execution.

• Aerobic and anaerobic fermentation
• Batch, fed-batch and draw-and-fill operating modes
• Microbial hosts including bacterial, yeast, fungal and select microalgal processes
• Temperature, pH and dissolved-oxygen control
• Feed preparation and additional strategies
• Harvest transfer into downstream processing

Designed to Reduce Scale-Up Friction

Keeping technology transfer, pilot work, commercial fermentation and downstream processing connected can reduce the loss of information that often occurs when projects move between organizations. The same project knowledge can remain active as the process advances.