Frequently Asked Questions

Our approach ensures that each customer receives a customized solution - never a 'one-size-fits-all' approach. At the same time, we provide standardized technology modules for fast, cost-effective results through our pick & choose model. Not every problem requires complexity; simplicity can be a powerful advantage. 

We offer flexible business models from standard service fees to customized R&D contracts to foster seamless collaboration and ensure that we are aligned with client´s goals. It's a partnership in which both sides work towards a common goal: the success of your project. 

Our modular approach allows you to select individual services or use BRAINBiocatalysts as an end-to-end development and manufacturing partner.  

You can start at any stage. We can discover a new enzyme, improve an existing enzyme, develop a production strain, optimize a bioprocess, scale up an established process, or manufacture an enzyme developed by you or another partner.  

Our knowledgeable team are here to help. Please contact us to find the right enzyme for you application. Contact Us.

Yes. Our application specialists can help assess enzyme performance under relevant process conditions. Depending on the project, this may include analytical method transfer or development, enzyme assays, product characterization, and application testing.  

No. Regulatory requirements and permitted applications vary by country and region. Please contact us to confirm the current regulatory status of a particular enzyme for your intended application and target market.  

Our services are highly customizable. The work program is designed around your enzyme, application, target properties, development stage, commercial objectives, timeline, and regulatory requirements.  

Projects are generally divided into defined work packages, milestones, and decision points, allowing you to maintain control over scope and investment.  

Our biological resources include the BioArchive, a collection of more than 50,000 microorganisms, and the MetXtra™ platform with extensive digital metagenomic sequence resources.  

These resources provide starting points for discovering novel enzymes, microorganisms, and production strains. They can also support customer-specific exclusivity and freedom-to-operate strategies, subject to the agreed contractual and licensing model.  

We have developed proprietary CRISPR-Cas-like genome-editing tools that can be used in microbial strain development. These technologies enable targeted genetic modifications and can accelerate the creation and optimization of production strains. Access may be provided through customer development projects or licensing models, depending on the technology and intended field of use.  

Yes. If you already have a suitable analytical method, we can transfer and adapt it for use in our laboratories. If no method is available, we can develop an assay for screening and characterizing the enzyme.  

Our analytical capabilities include microplate-based assays as well as HPLC- and GC-based methods.  

Our production platforms include:  

• Escherichia coli  
• Bacillus species  
• Komagataella phaffii (Pichia pastoris) 
• Kluyveromyces lactis  
• Yarrowia lipolytica  
• Aspergillus niger  

Additional bacterial, yeast, and fungal strains are available for screening, strain development, biomass production, and the production of enzymes, proteins, and other biomolecules.  

We develop microbial production systems for recombinant enzymes, proteins, peptides, and other biomolecules. Our capabilities include host selection, expression cassette design, strain engineering, fermentation development, downstream processing, and scale-up.  

Yes. Our Plug & Produce packages provide a standardized way to assess whether an enzyme can be produced in selected microbial hosts. Depending on the package and production organism, different gene designs, promoters, signal peptides, integration strategies, or strain variants can be evaluated. 

Yes. Depending on the project and organism, we can use non-GMO strain improvement approaches such as classical mutagenesis, UV treatment, selection of spontaneous mutations, and adaptive laboratory evolution.

Yes. We develop fermentation and downstream processes from laboratory scale through pilot scale and commercial manufacturing.  

Process development may include media and feeding strategy optimization, process parameter development, Design of Experiments, process intensification, downstream processing, formulation, and stability work.  

Yes. You do not need to use our discovery or engineering services before entering manufacturing. If you already have a production strain or an established process, our teams can assess technology transfer, optimize the process where necessary, and scale it up for commercial production.  

Our Cardiff facility provides pilot-scale fermentation from 70 to 750 liters and large-scale fermentation capacity of up to 2 × 10,000 liters. Through our wider production network, larger fermentation capacities may also be available.  

The facilities support the transition from process development to routine commercial enzyme manufacture.

Yes. Following development, validation, and scale-up, we can manufacture enzymes routinely according to agreed specifications and supply schedules.  

Routine supply may include quality control, formulation, stability testing, regulatory documentation, application support, and supply optimization.  

Please visit our Quality and Compliance area to find the relevant information. 

Yes. We can provide technical data and documentation to support regulatory processes, including submissions to authorities such as EFSA and the FDA. The exact scope depends on the enzyme, application, target market, and contractual agreement.  

Contact us with a short description of your enzyme, application, production, or process challenge.  

Following an initial non-confidential alignment a project usually begins with a confidential consultation with our business development and scientific teams. We discuss your technical requirements, application, development status, commercial objectives, and timeline.  

Based on this information, we prepare a proposal covering the scientific work plan, milestones, deliverables, commercial terms, and estimated costs.  

Projects are typically structured around defined work packages, milestones, and decision points. You remain involved throughout the project process and receive the information needed to make informed go/no-go decisions.  

Project managers coordinate the scientific disciplines and maintain communication between your team and the BRAINBiocatalysts experts.  

Background intellectual property remains with its original owner. The ownership and use of foreground intellectual property generated during a project are defined in the individual research and development agreement.  

Rights to proprietary BRAINBiocatalysts resources, technologies, strains, genes, enzymes, or expression systems may be provided through exclusive or non-exclusive licenses. The model is tailored to the project and intended commercial application.