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Bioprocess Development & Scale-up

Bioprocess Development & Scale-up

Partner with us for bioprocess excellence

We specialize in designing customized bioprocesses to advance microbial enzyme and protein production.

  • Our team of experienced specialists, with extensive knowledge of diverse microbial production strains, is dedicated to optimizing bioprocesses that drive enzyme and protein development.
  • Bioprocess development includes: upstream process development (USP), downstream process development (DSP) and scale-up. 
  • From our state-of-the-art fermentation facilities, we accelerate small-scale development and seamlessly transition processes to pilot scale. 
  • Our strategies to maximizing product yields and optimizing processes keeps you ahead of the competition and ensures long-term success.
  • Microbial strain development and bioprocess development go hand in hand and are equally important to achieve a commercially viable production. Both technological areas receive our full attention, and we take a holistic approach. 

 

Bioprocess Development & Scale-up

Upstream process development

reliable fermentation partner with a proven track record

Our team specializes in establishing and optimizing fermentation processes for a wide range of microorganisms like bacteria, yeasts, and filamentous fungi. 

Upstream process development (USP) capabilities include:

  • Industrial strains: Deep knowledge with
    • Escherichia coli
    • Bacillus subtilis
    • Bacillus licheniformis
    • Komagataella phaffii (Pichia pastoris)
    • Kluyveromyces lactis
    • Aspergillus niger
  • Process optimization: From lab-scale experiments to pilot-scale production (milliliter-scale to 200 liters).
  • Scale-up and validation: DOE experiments, scale-down approaches, and process simulation.
  • Flexibility: Flexible equipment and highly skilled staff to address virtually any challenge.

Our expertise extends to technological and regulatory affairs, offering guidance on regulatory approval and plant design. 

Immediate access to industrial production capabilities: 

  • When using our bioprocess and scale-up services, we can also provide access to our industrial production facility at Biocatalysts Ltd., Cardiff.
  • Benefit from established processes, workflows, seamless technology transfer and scale-up to save time and resources.  

Downstream processing

Maximize yields after downstream processing

By working closely with our fermentation specialists, we ensure that your downstream processing (DSP) aligns with upstream conditions. Our in-house analytics provide real-time monitoring and evaluation of your target molecule throughout the entire process. This data-driven approach allows us to make informed decisions and fine-tune your DSP for maximum efficiency.

DSP estalishment and optimization includes:

  • Our state-of-the-art equipment and handling a wide range of downstream operations
  • Cell separation: Centrifugation, depth filtration, flocculation, and crossflow for all fermenter scales.
  • Cell disruption: Up to 20 liters.
  • Protein purification: From small-scale laboratory experiments to large-scale manufacturing, using various TFF systems and chromatography techniques.

Scale-up & technology transfer

We are Your Partner for Fermentation Scale-Up and Beyond

Our team offers comprehensive technical support and process characterization throughout the scale-up stages, from 1L to 200L. Our flexible equipment and highly experienced staff can handle virtually any challenge that may arise during development.

Scale-up opportunities:

  • Scale-up and transfer to CMO: With BRAIN Biotech Group company Biocatalysts Ltd. we can scale and transfer bioprocesses to an agile and flexible CMO with remarkable fermentation volumes that is specialized on the production of speciality enzymes. Benefit from established processes, workflows, seamless technology transfer and scale-up to save time and resources.  
  • CMO network: We are also very experienced and offer scale-up and transfer to client's production facilities or any selected CMO. 
  • Seamless technology transfer: Our team ensures a smooth transfer of knowledge, product, analytical methods and process information.
  • Regulatory support: Benefit from our expertise in regulatory affairs to navigate the complexities of scaling up and commercializing your fermentation process.

USP development

Upstream process development

reliable fermentation partner with a proven track record

Our team specializes in establishing and optimizing fermentation processes for a wide range of microorganisms like bacteria, yeasts, and filamentous fungi. 

Upstream process development (USP) capabilities include:

  • Industrial strains: Deep knowledge with
    • Escherichia coli
    • Bacillus subtilis
    • Bacillus licheniformis
    • Komagataella phaffii (Pichia pastoris)
    • Kluyveromyces lactis
    • Aspergillus niger
  • Process optimization: From lab-scale experiments to pilot-scale production (milliliter-scale to 200 liters).
  • Scale-up and validation: DOE experiments, scale-down approaches, and process simulation.
  • Flexibility: Flexible equipment and highly skilled staff to address virtually any challenge.

Our expertise extends to technological and regulatory affairs, offering guidance on regulatory approval and plant design. 

Immediate access to industrial production capabilities: 

  • When using our bioprocess and scale-up services, we can also provide access to our industrial production facility at Biocatalysts Ltd., Cardiff.
  • Benefit from established processes, workflows, seamless technology transfer and scale-up to save time and resources.  

DSP development

Downstream processing

Maximize yields after downstream processing

By working closely with our fermentation specialists, we ensure that your downstream processing (DSP) aligns with upstream conditions. Our in-house analytics provide real-time monitoring and evaluation of your target molecule throughout the entire process. This data-driven approach allows us to make informed decisions and fine-tune your DSP for maximum efficiency.

DSP estalishment and optimization includes:

  • Our state-of-the-art equipment and handling a wide range of downstream operations
  • Cell separation: Centrifugation, depth filtration, flocculation, and crossflow for all fermenter scales.
  • Cell disruption: Up to 20 liters.
  • Protein purification: From small-scale laboratory experiments to large-scale manufacturing, using various TFF systems and chromatography techniques.

Scale-up

Scale-up & technology transfer

We are Your Partner for Fermentation Scale-Up and Beyond

Our team offers comprehensive technical support and process characterization throughout the scale-up stages, from 1L to 200L. Our flexible equipment and highly experienced staff can handle virtually any challenge that may arise during development.

Scale-up opportunities:

  • Scale-up and transfer to CMO: With BRAIN Biotech Group company Biocatalysts Ltd. we can scale and transfer bioprocesses to an agile and flexible CMO with remarkable fermentation volumes that is specialized on the production of speciality enzymes. Benefit from established processes, workflows, seamless technology transfer and scale-up to save time and resources.  
  • CMO network: We are also very experienced and offer scale-up and transfer to client's production facilities or any selected CMO. 
  • Seamless technology transfer: Our team ensures a smooth transfer of knowledge, product, analytical methods and process information.
  • Regulatory support: Benefit from our expertise in regulatory affairs to navigate the complexities of scaling up and commercializing your fermentation process.

Want to explore even more in bioprocessing and scale-up?

Are you looking to streamline your process and make it ready for scale-up, troubleshoot specific issues, or validate your entire process? Or perhaps you need a manufacturing partner to scale up your production?

If so, we invite you to connect with us and explore how we can drive your developments forward. At BRAIN Biotech Zwingenberg, we are committed to delivering tailored biosolutions to meet your specific challenges.

 

End-to-end services: from discovery to manufacturing

A technician with gloves twists on a bioreactor's closure cap.

From lab to market, we are your integrated solution provider for manufacturing.

Our end-to-end services ensure a seamless transition from establishment to large-scale industrial production at Biocatalysts Ltd.

If challenges related to the product or production strain arise during bioprocess development, our colleagues from enzyme technology and microbial strain development are ready to provide targeted and rapid support.

 

Specialized Expertise

All projects benefit from extensive support

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Bioinformatics & AI
as key drivers for innovative, targeted and efficient developments
Bioinformatics & AI

Key driver for targeted and efficient developments

Icon with Computer screen as symbol for Bioinformatics

integration of bioinformatics and AI into projects to maximize project success

A strong interaction between bioinformaticians and our scientific teams is a key element for targeted and efficient developments. We are experienced not only in working with large datasets but also in identifying the ideal approach based on limited or no prior knowledge.

Benefit from the combination of a wide array of bioinformatics and AI technologies together with a long track record of biotechnology expertise.

Holistic solutions for optimal results:

  • Tailored and targeted to your individual project by integrating scientific teams and bioinformaticians to deliver optimal results
  • Committed to identifying the ideal path by leveraging technologies ranging from physics-based bioinformatics to data science and AI
  • Regular provision of solutions based on large datasets and sparce knowledge
  • Holistic solutions enabled by a wide range of expertise from enzyme design, NGS, strain sequencing including genomics and transcriptomics to bioprocess development
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Instrumental Analytics
accompanies projects for precise, detailed and controlled execution
Instrumental Analytics

Support of projects for precise, detailed and controlled execution

Sketch of a chromatography curve as a symbol for instrumental Analysis

Versatile & flexible instrumental analytics 

Our experienced team collaborates closely with yours, ensuring a seamless workflow from start to finish. Whether you need precise elemental analysis for production optimization or accurate protein quantification for process development, our in-house expertise delivers results.

Instrumental analytics at BRAIN Biotech:

  • We provide technical guidance throughout the whole project from planning to the actual method development, validation, process characterisation, target quantification, stability testing and technology transfer, e.g. to GMP-certified laboratories if required.
  • Numerous methods for various analytes already available on which to build
  • Tailored and efficient analytical method development, technical guidance, validation, documentation (SOP) and technology transfer
  • Broad instrumentation from ICP-MS to GC and HPLC for full analyte spectrum
  • Wide range of sample preparation techniques to work with complex biological matrices.
  • Our analytical team provides the necessary documentation such as SOPs to maximize the efficiency of the transfer process.
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Quality Management
ensures compliance, risk mitigation and seamless project execution
Quality Management

Ensuring quality, risk mitigation, and seamless project execution

Document with a ticked checklist as Symbol for Quality management

Backing-up scientists by Quality Management & Process Transfer teams

To enable our scientists to focus fully on delivering exceptional project results for our clients, they are backed up by the Quality Management & Process Transfer team, which ensures regulatory requirements are met and consistent quality is maintained.

A comprehensive set of Standard Operating Procedures (SOPs) provides the foundation for achieving project objectives and ensures reproducible and comparable results. Additionally, the Quality Management & Process Transfer team ensures that all documentation requirements are met, enabling the success of innovative projects and transfer of processes.


Quality Management & Process Transfer

  • At the start of each project, we conduct a risk analysis and pre-mortem with a team of experts, proactively identifying and eliminating potential obstacles from the outset. 
  • During project execution, we support the qualification of suppliers and the selection of raw materials, considering both their suitability and availability at production scale within the relevant regulatory framework.
  • Project-specific methods and processes are documented and made available for technology transfer to customers, external CDMOs or within the BRAIN Biotech Group. 

Explore further technology services

Enzymes & Proteins
Microorganisms & Production Strains

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