What We Offer
Are you looking to scale your biotech process to an industrial level? Do you require additional production capacity for an established process, support in building a new one from the ground up or in optimizing an existing process?
At Corden BioChem, we offer end-to-end support to your biotech products: from initial process development and lab-scale implementation through technology transfer, piloting, upscaling, process optimization, and ultimately the production of high-quality, certified commercial products.
Our Technologies
- Fermentation
Our Berlin site’s processes transfer smoothly to the Frankfurt operations. Our 3,000 L pilot fermenters allow us to simulate the characteristics of our 120,000 L production fermenters. This enables us to generate scalable process know-how for commercial production in Frankfurt or Podari.
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- Downstream Processing
We operate a state-of-the-art, highly automated, large-scale DSP facility. We have a range of bench- and pilot-scale equipment that allows us to simulate the characteristics of our large-scale DSP before upscaling.
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- Separators, e.g., nozzle centrifuge and disc stack centrifuge
- Crossflow & spiral wound membrane filtration systems (MF / UF / RO)
- Adsorption & ion exchange chromatography
- Enzyme reactors
- Crystallization and precipitation
- Blender
- Belt filter
- Continuous thin-film dryer
- Different filling options: Tank containers, tank trucks, IBCs, filling cabin for contained packaging
- Continous monitoring: 4 shifts, 24/7 all year round
- Food-grade facility (FSSC 22000)
- Option of setting up customized process equipment or process lines
- Cooperation network with external partners, e.g., for spray drying
- Analytics & Quality
We have a comprehensive set of instruments for process monitoring & release testing as well as established measures to ensure delivery of high-quality product.
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- Raw material control, in-process monitoring and product release testing via HPLC, GC, spectrophotometry, enzymatic tests, and many others
- Separate fermentation lines for Food-grade (FSSC 22000) and technical products
- FSSC 22000 certified and FDA registered facility
- Religious certification for Halal and Kosher upon request
- On-site warehouse capacities for raw and auxiliary materials and product storage at different temperatures
- Waste management incl. biogas plant, on-site wastewater treatment
Process Development & Prototyping
Corden Biochem offers process development capabilities in lab and pilot scale and the production of food grade prototypes. With the acquisition of a highly skilled team and state of the art equipment in Berlin, we can scale-up your product ideas and produce sample material tailored to rapidly validate and advance your concept toward pilot and full production scale.
The highly dedicated team of scientists, technicians, quality specialists, and project managers build on many years of experience in process development, upscaling and tech transfer in different fields ranging from enzyme and carbohydrate production to the successful development of pro- and postbiotics in large scale. The close connection to our pilot and production sites provides an in-depth understanding of scalable processes and an early assessment of production costs in large scale.
We offer Project management for all development activities including knowledge sharing and reporting as well as data handling and analysis to support data-driven decisions (e.g., design of experiments).
Stability testing at different temperatures and relative humidity is conducted in conformance to ICH guidelines.
Upscaling services
Our expertise lies in effectively transferring processes from the lab-stage to large-scale production.
Once a cooperation framework is established, the technology transfer process begins. We conduct a detailed evaluation of the customer’s process and adapt it, if necessary, to align with our equipment and capabilities. After successful process development or prototyping, an internal tech transfer ensures a smooth handover to pilot and production sites. The exchange of production strain, process information, analytical methods, and accompanying documentation takes place to facilitate a seamless transfer.
We conduct one or several test fermentations in a 3,000 L scale to validate the technical setup and generate tech-grade test material.
If required, downstream processing is tested in laboratory and/or pilot-scale settings.
We customize our facility to accommodate the specific needs of the customer’s process, implementing new equipment, if necessary.
The first large-scale fermentation in one of our 120,000 L gross volume fermenters demonstrates the technical feasibility of the production process. We generate first higher volumes of product during this stage, including downstream processing of the fermentation broth to product concentrate or powder, if required.
In subsequent batches, we continuously evaluate and improve the process performance by varying process parameters and ensuring process reproducibility.
Contract Manufacturing
We manufacture your product on a large scale, ensuring adherence to strict quality control measures and conformity to product specifications.
We are open to customizing our equipment to suit your specific product requirements. Please reach out to discuss our options.
We use our extensive process knowledge and expertise in operating our equipment, and strive to improve process performance, titers, and yields from one production campaign to the next.
We offer a range of flexible business models, including campaigning, annual contracts, several-year contracts, pay-per-batch, pay-per-kilogram, as well as strategical partnerships.
