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End-to-end enzyme development:<br>A better way to innovate

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

When every stage of enzyme development is connected, innovation moves faster, risks are reduced, and better outcomes become possible.

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 (Contract Development and Manufacturing Organization) 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 the RESEARCH & INNOVATION CENTER where the 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 PRODUCTION OPERATIONS.

Scale-up and manufacturing

Once the process is established at pilot scale, it is transferred to PRODUCTION OPERATIONS. 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.

Move faster with an integrated biotech organization

Specialists in every phase of development

As a strong end-to-end partner we provide true experts at every stage of development. At BRAINBiocatalysts, each technological field is also offered as a standalone service. This means every capability must represent the state of the art, and our scientists must be recognized experts in their respective fields to meet the high customer expectations.

The strength of the BRAINBiocatalysts setup lies in bringing our specialized expert teams together into one seamlessly integrated workflow. Through close collaboration, aligned processes, and continuous communication, the modular capabilities are combined into a single end-to-end offering.

What does this mean for you?

  1. Faster time to market with one integrated partner from enzyme development to manufacturing

  2. Lower project risk by designing enzymes, strains, and processes for scalability from the start

  3. Higher yields and consistent quality through integrated expertise across the entire process

  4. Smoother scale-up from lab to industrial production with fewer handover issues and less troubleshooting

  5. One trusted partner with expert teams at every stage

Find the right level of support for your project

Our technologies and services can be used individually or combined into a fully integrated development program. Explore our capabilities or speak with our team to identify the approach that best fits your goals.

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