End-to-end enzyme development - A better way to innovate

Moving an enzyme from lab work to large-scale manufacturing is rarely straightforward. Results that look promising in small experiments often don’t carry over to industrial scale.

Many companies rely on different partners for each stage of the process for 

1. enzyme development, 
2. bioprocess development and scale-up, and 
3. contract manufacturing. 

When development and manufacturing are handled by different organizations, this usually leads to delays, lower yields, and repeated troubleshooting.  

Common issues include changes in fermentation behavior at larger volumes, longer processing times that affect product quality, and inefficient transfer of know-how between teams.

BRAINBiocatalysts addresses this by working in a single, coordinated CDMO setup by combining the expertise of tightly integrated contract research and contract manufacturing expert teams. 

Enzyme development and manufacturing are connected end-to-end which helps avoid typical handover issues and keeps projects moving without unnecessary setbacks.

Enzyme, strain & bioprocess development

The work begins at our RESEARCH & INNOVATION CENTER where our expert teams in enzyme technology, microbial strain development, and bioprocess development work side by side. Through interdisciplinary collaboration, new enzymes are discovered, optimized using rational engineering, and high-performance microbial production strains are constructed.

Maximizing enzyme production titers

At laboratory scale, enzyme production titers are maximized. Common microbial production strains for enzymes at BRAINBiocatalysts include bacteria like E. coli and Bacillus, yeasts like Komagataella phaffii and filamentous fungi such as Aspergillus.

To ensure these high titers translate into equally high yields at fermentation scale, our fermentation processes are designed with scalability in mind from the very beginning. Instead of relying on trial and error, the team defines key process parameters early and tests them systematically. Key conditions including pH, temperature, oxygen levels, and feeding strategies are adjusted using structured experimental designs and process models. This allows a controlled stepwise scale-up from small lab volumes to pilot scale of up to 200 L. Cell bank generation is included at this stage, ensuring a stable and reproducible starting point for later manufacturing.

Downstream processing is developed alongside fermentation to avoid bottlenecks later. Available tools include filtration systems, centrifuges, and tangential flow filtration (TFF) units at different scales. For higher purity needs, chromatography is also available. Analytical work (instrumental analytics and assays) supports all steps, covering process monitoring, validation, and stability.

This early integration creates the foundation for efficient technology transfer into our PRODUCTION OPERATIONS unit.

Scale-up and manufacturing

Once the process is established at pilot scale, it is transferred to our MANUFACTURING OPERATIONS unit. The transfer follows a structured approach to ensure that performance remains consistent when volumes increase.

• Initial runs at 750 L are used to confirm the process under manufacturing conditions. From there, production can move to 10,000 L fermenters, with additional production capacity available as required.
• Downstream processing at this stage includes large-scale centrifugation, filtration, and chromatography.
• Final products can be delivered as liquids or dried powders using spray drying or freeze drying, depending on requirements.

All work follows relevant regulatory standards, whether for pharmaceutical, food, or specialty enzyme applications, including requirements such as Kosher and Halal certification.