Bioprocess Development
What's in for you?
- Accelerated path to market with a customized bioprocess designed for reliable scale-up from day one.
- Maximized product yield, recovery, and purity through integrated fermentation, downstream processing, and in-house analytics.
- Reduced technical risk, development time, and resource use with systematic optimization, robust validation, and manufacturing-focused process design.
- Seamless move into commercial production with expert regulatory support, efficient technology transfer, and flexible manufacturing options
Fermentation development
We develop customized, scalable bioprocesses that accelerate microbial enzyme and biomolecule production. Our experienced fermentation team works with bacteria, yeasts, filamentous fungi, and industrial production strains across scales (250 ml, 2 L, 10 L, 20 L, 200 L).
Deep knowledge with:
- Escherichia coli
- Bacillus subtilis
- Bacillus licheniformis
- Komagataella phaffii (Pichia pastoris)
- Kluyveromyces lactis
- Aspergillus niger
Through systematic process optimization, design of experiments (DoE), scale-down models, process simulation, and robust validation, we create efficient upstream processes designed for reliable scale-up. Flexible equipment and highly skilled specialists enable us to address even complex production challenges.
We also support you with regulatory strategy, technology assessment, and plant design. When your process is ready, gain immediate access to our industrial manufacturing capabilities. Established workflows and seamless technology transfer help you move into production faster. This saves time, reduces risk, and conserves resources.
Downstream process development
Maximize product recovery, purity, and yield with a downstream process tailored to your target enzyme or biomolecule. Our downstream and fermentation specialists work closely together to align every purification step with upstream process conditions. In-house analytics track your target molecule throughout development, providing the data needed to optimize performance, minimize product loss, and build an efficient, scalable process.
Our capabilities cover a wide range of downstream operations, including cell separation by centrifugation, depth filtration, flocculation, and crossflow filtration at all fermentation scales. We also offer cell disruption for volumes of up to 20 l, as well as protein concentration and purification using multiple tangential flow filtration (TFF) and chromatography technologies.
With flexible, state-of-the-art equipment and integrated expertise, we develop robust downstream processes ready for seamless scale-up and manufacturing.
Bioprocess development with manufacturing in mind
We develop every fermentation process with its final manufacturing environment in mind.
By considering production requirements from the outset,
- we reduce scale-up risks,
- avoid costly redevelopment,
- and accelerate your path to commercial production.
Our experienced team provides comprehensive technical support and process characterization throughout every scale-up stage.
Flexible equipment and established workflows allow us to address complex challenges and build robust, transferable processes.
Scale-up and manufacturing can take place at BRAINBiocatalysts Manufacturing Operations in Cardiff, at your own production facility, or at a selected contract manufacturing organization (CMO).
We ensure seamless technology transfer by providing the required process knowledge, analytical methods, product specifications, and technical documentation.
Our regulatory experts also support you in navigating approval requirements.
