Dr. Christian Naumer
is our expert in the field of Bioprocess Development
Do you have a production strain but lack the time and resources to develop a bioprocess? We can do this for you - because developing and optimizing bioprocesses on a laboratory scale is our daily business.
The producer strains we use include:
Wild-type and GMO: We use both wild-type strains and genetically modified organisms to develop the production strain.
Knowledge of regulatory requirements: We have extensive knowledge of the regulatory requirements for a pharmaceutical manufacturing process and take these into account when developing a bioprocess.
Starting in milliliter-scale: To accelerate process development, we use a miniaturized cultivation system on a milliliter-scale with process-like conditions and design of experiments (DoE) in the early stages. Further development is carried out in small-scale stirred tank reactors, always keeping scalability in mind.
Validation studies: As we are able to scale down experiments for higher throughput, we can perform process validation studies for your regulatory approval.
Protein purification: We offer a wide range of protein purification options for the purification of target molecules. Various solid-liquid separation (SLS), ultrafiltration (UF) and chromatography methods are available from the milliliter scale to the scale of several hundred liters.
Five reasons why to choose BRAIN Biotech for process development and optimization:
We offer novel and sophisticated approaches for the discovery of functional biomolecules and cost-effective biobased processes. As the associated workflows require a wide range of techniques at the interface of biology and chemistry, our instrumental analysis covers an equally broad range of relevant analytes.
Elements and molecules: We analyze elements as well as small and large molecules, including intact proteins. In addition, our laboratory covers a wide range of sample preparation techniques such as SPE, SPME, Soxhlet extraction, pre- and post-column derivatization to work in different biological matrices.
Strong instrumental analytical capabilities: When it comes to selecting the best enzyme, monitoring a specific biochemical pathway or the biochemical pathway or the metal-binding capacity of a microbe selected for bio-mining, we can provide strong instrumental analytical capabilities and provide reliable answers. With our state-of-the-art instrumentation and highly experienced staff we accompany research and development projects from their inception - through to the final implementation of quality and stability controlsand stability testing.
Developing analytical methods for pharmaceutical applications is daily business at BRAIN Biotech. Our Analytics team interacts closely with the respective project partner. We develop HPLC-based process-relevant methods for protein purity control and protein quantification in various formulations and concentration ranges (low single-digit µg/ml to mg/ml range).
Methods validation: We perform a method validation process for all methods to ensure robustness of the data and accompany the technical transfer of the methods to certified and/or GMP laboratories.
Supporting transfer process: Our analytics team provides all necessary documentation such as SOPs to maximise the efficiency of the transfer process.
Services: In addition, we regularly measure routine samples and advise on analytical issues.
Structure elucidation & NMR analysis: Our
analytical laboratory interacts closely and works hand-in-hand with all
other technology departments. We also maintain a close synergy with our
subsidiary Analyticon Discovery to ensure an efficient flow of
information, methodology and knowledge between the scientists of both
companies. In addition to our own expertise, we therefore have strong
internal support in areas such as structural elucidation and NMR
analysis. We also collaborate with specialised analytical laboratories
to fill the gaps in areas we cannot cover ourselves.
In brief, we cover the following separation and detection methods with our in-house equipment:
Three additional reasons why to choose us for analytics support:
Bioreactors ranging from 1 L to 200 L are available at BRAIN Biotech's research campus in Zwingenberg for the development and scale-up of bioprocesses. We have a track record of successfully transferring processes to our subsidiary Biocatalysts in Cardiff or to GMP contract manufacturers. We have successfully scaled up several processes from 1L to 40m3.
Three additional reasons why to choose us for process scale-up and tech transfer:
Benjamin Lebkuechner, M. Eng.
Benjamin has extensive technical understanding and knowledge of maintenance and support of bioprocessing utilities and equipment.
Anke Bachert, Dipl. Ing., M. Sc.
Expert in analytics and extensive experience in:
Jan Freytag, M. Eng.