cdmo services
Enzymes
EUROAPI has published a white paper describing the case study of the recombinant transaminase production process development, from enzyme screening through miniaturized system to final scale-up in pilot plant (10m3), which was performed by the R&D department of EUROAPI Brindisi.
The results described in this white paper support the end-to-end development approach applied by the EUROAPI R&D team to recombinant enzyme production. These results enable a complete process development train, from lab to pilot scale with batch manufacturing up to 10m3 scale.
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Our Brindisi site holds equipment and upstream (USP) & downstream (DSP) processing capacities for enzyme production from lab scale development to pilot manufacturing (10m3):
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1. Small scale process development
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2. Upstream and process development capacity
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3. Downstream development at lab-scale
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4. Kilo-lab equipment for kilo-batch manufacturing (pilot scale)
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5. Analytical method development and support
1. Small scale process development, enzyme and strain screening
- Dedicated laboratory and equipment for small scale process development
- Automated liquid-handling systems for miniaturized processes
- 2 high-throughput screening automated platforms
- Automatic plating station
- Automatic colony picking station with appropriate software and databases
![EUROAPI_Enzymes-Small scale](/sites/default/files/styles/image_430x335/public/2024-01/euroapi_enzymes-small-scale-2_0.jpg?itok=QPbsH89F)
2. Upstream and process development capacity suitable for high cell density fermentation (e.g., E. coli and P. pastoris) and filamentous fungi and bacteria
- 1L-scale parallel bioreactor system
- Fermenters: 20L-scale, 30L-scale and 40L-scale
- Cell-container
- Pure oxygen line supply at lab scale
- Off-gas analysis systems
![EUROAPI_Enzymes-Upstream](/sites/default/files/styles/image_430x335/public/2024-01/euroapi_enzymes-upstream-1.jpg?itok=R9kRsCeQ)
3. Downstream development at lab-scale
- Cell lysis equipment for intracellular product recovery
- Centrifugation system: Ultracentrifuge
- Filtration system (TFF)
- Microfiltration (ceramic)
- Ultrafiltration (spiral wound and cassette)
- Chromatographic systems for protein purification (FPLC)
- Spray dryer and freeze dryer technologies
![EUROAPI_Enzymes-Downstream](/sites/default/files/styles/image_430x335/public/2024-01/euroapi_enzymes-downstream-1.jpg?itok=MyDgNYu5)
4. Kilo-lab equipment for kilo-batch manufacturing (pilot scale)
- Upstream
- 600L no-GMP bioreactor
- 10m3 no-GMP bioreactor
- Downstream
- Cell lysis equipment for intracellular product recovery
- Disk stack centrifuge
- Microfiltration & Ultrafiltration (TFF multipurpose system)
- Chromatographic systems for protein purification (FPLC)
- Freeze-drying technologies
![EUROAPI_Enzymes-Pilot plant](/sites/default/files/styles/image_430x335/public/2024-01/euroapi_enzymes-pilot-plant.jpg?itok=xHcTF2UY)
5. Analytical method development and analytical support at all the steps of process development and manufacturing
- HPLC and UPLC method development for products, impurities, metabolites quantification
- Triple quadrupole mass spectrometer
- Enzymatic activity assay development and quantification
- Analytical methods for protein expression quantification
![EUROAPI_Enzymes-Analytics](/sites/default/files/styles/image_430x335/public/2024-01/euroapi_enzymes-analytics-1_0.jpg?itok=pU4AN4dz)