Configurable bioreactor systems, xCUBIO automation and sterile sampling technology from 250 ml to 10.000 liters
bbi-biotech GmbH
Berlin-Adlershof (Ernst-Lau-Strasse 5, 12489) · Landsberger Str. 259, 12623 BerlinNew on Amplifa
About bbi-biotech
bbi-biotech GmbH was founded in Berlin in 2009 and develops, manufactures and distributes bioreactors and fermenters of the xCUBIO series for all biotechnological applications. The portfolio ranges from benchtop systems with 250 ml to 10 liters working volume and parallel bioreactors with 2 to 24 vessels, SIP-capable pilot-scale systems made of stainless steel (2 to 100 liters) and CIP/SIP-capable production bioreactors (100 to over 10.000 liters) through to photobioreactors and complete seed-to-production plants. Double-jacketed borosilicate glass vessels, stainless steel vessels and disposable bags made of film plastic are used. In addition to new plants, the company implements retrofit and modernization projects for existing bioreactors (including B. Braun, Sartorius/Biostat), automation tasks in the GMP environment as well as the patented, automated sterile sampling system bioPROBE. Customers come from biotechnology, pharma, food, agriculture, wastewater treatment and cell culture; the systems are delivered, installed and serviced worldwide. Since November 2021 the GmbH has been located in the Adlershof technology park in Berlin.
- Site
- Berlin
- Processes
- Benchtop bioreactors (fermentation and cell culture), Parallel bioreactors (2–24 vessels, modular process development), Pilot-scale bioreactors (SIP-capable stainless steel systems), Production bioreactors (CIP/SIP-capable, sterile transfer, seed-to-production lines), Retrofit bioreactors (modernization of existing systems with xCUBIO automation), Photobioreactors (phototrophic cultivation, laboratory to production scale), Automated sterile bioreactor sampling (bioPROBE, dosing, filtering, storing), Maintenance, repair, spare parts, consumables (lifecycle support)
- Materials
- Borosilicate glass (double-jacketed glass vessels), Stainless steel, Film plastic (single-use bag, disposable), Borosilicate glass, Film plastic (disposable bag)
- Certificates
- IQ/OQ, FAT/SAT, GAMP5, 21 CFR Part 11, Calibration service, ISO 9001
- Founded
- 2009
- Industries
- Biotechnology, Pharma, Food, Agriculture/Agro-biotechnology, Wastewater treatment, Cell culture
- 01
Consulting / Pre-Engineering
- 02
Basic and Detail Engineering
- 03
Design and Vessel Engineering
- 04
Automation (xCUBIO)
- 05
Plant Construction / Assembly
- 06
Qualification (IQ/OQ, FAT/SAT)
- 07
Maintenance, Spare Parts, Lifecycle Support
Materials and System Configurations
Stainless steel
Vessel material for SIP-capable pilot and CIP/SIP-capable production bioreactors from 2 to over 10.000 liters.
Borosilicate glass
Double-jacketed glass vessels for benchtop bioreactors, partly autoclavable.
Film plastic (disposable bag)
Single-use bags of the GE-Xcellerex XDR series with 50 to 2000 liters culture volume for cell culture in GMP environments.
Locations
Berlin-Adlershof
DEHeadquarters, engineering and production (Adlershof technology park, since 11/2021)
- Part weight / size
- Bioreactors from 250 ml to 10.000 L+
- Lot size
- Single systems up to complete plant lines
- Materials
- Stainless steel, borosilicate glass, film plastic
- xCUBIO bioreactor systems (benchtop, twin, multi, in-situ)
- xCUBIO phar photobioreactors
- bioPROBE automated sampling system
- Retrofit/refurbishment automation
- Steam generators up to 40 kg steam/hour
Products and Systems
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Benchtop bioreactors (fermentation and cell culture)Engineering | – | – | 250 ml – 10 L | – | Borosilicate glass, Stainless steel |
| Parallel bioreactors (2–24 vessels, modular process development)Engineering | – | – | – | 2 vessels – 24 vessels | Borosilicate glass, Stainless steel |
| Pilot-scale bioreactors (SIP-capable stainless steel systems)Engineering | – | – | 2 L – 100 L | – | Stainless steel |
| Production bioreactors (CIP/SIP-capable, sterile transfer, seed-to-production lines)Engineering | – | – | 100 L – 10.000 L+ | – | Stainless steel |
| Retrofit bioreactors (modernization of existing systems with xCUBIO automation)Engineering | – | – | – | – | – |
| Photobioreactors (phototrophic cultivation, laboratory to production scale)Engineering | – | – | – | – | – |
| Automated sterile bioreactor sampling (bioPROBE, dosing, filtering, storing)Engineering | – | – | – | – | – |
| Engineering | – | – | – | – | – |
| Maintenance, repair, spare parts, consumables (lifecycle support)Assembly | – | – | – | – | – |
| Documentation: calibration, IQ/OQ, FAT/SAT, PQ, GAMP5, 21 CFR Part 11Testing | – | – | – | – | – |
| Training and operator instruction for bioreactor operationAssembly | – | – | – | – | – |
| Pre-engineering and technical consultingEngineering | – | – | – | – | – |
10 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Benchtop bioreactor system xCUBIO | bbi-biotech xCUBIO | – | 250 ml – 10 L | – | Berlin |
| Parallel bioreactor system | bbi-biotech xCUBIO twin / xCUBIO multi | – | 2–24 vessels | – | Berlin |
| In-situ sterilizable fermenter / production bioreactor | bbi-biotech xCUBIO in-situ | – | 100 L – 10.000 L+ | – | Berlin |
| Photobioreactor (glass tube module) | bbi-biotech xCUBIO phar | – | 5 l total volume (autoclavable); phar 25: 20 l glass tube module | – | Berlin |
| Automated sterile sampling system | bbi-biotech bioPROBE (incl. bioPROBE quad, iceBLOCK) | – | – | – | Berlin |
| Fermenter plant with seed fermenter | bbi-biotech | 1 | Main fermenter max. 5.000 L culture suspension (7.200 L vessel), seed fermenter 100 L | 2015 | ABiTEP GmbH |
| Fermenter plant | bbi-biotech xCUBIO | 1 | 650 l | – | Customer (agro-biotechnology) |
| Steam generator | bbi-biotech | – | up to 40 kg steam/hour | – | – |
| CIP system | bbi-biotech | 1 | – | 2015 | ABiTEP GmbH |
| Disposable bioreactor system (single-use bag) | GE-Xcellerex XDR series | – | 50 to 2000 l culture volume per bag | – | – |
Additional services
Reference customers
Qualification and Documentation
The systems are delivered with qualification and documentation services according to GAMP5 and 21 CFR Part 11, including IQ/OQ, FAT/SAT and calibration service; special control tasks in the GMP environment are implemented.
| Evidence | Berlin-Adlershof |
|---|---|
| IQ/OQ, FAT/SAT, GAMP5, 21 CFR Part 11 | |
| Calibration service | |
| ISO 9001 |
History
- 2009
Foundation of bbi-biotech GmbH in Berlin
- 2011
Delivery of a pilot fermenter (650 L) for soil bacteria fermentation to ABiTEP
- 2015
Handover of a turnkey 7200-liter fermenter plant (5000 L culture volume, 100 L seed fermenter, SIP/CIP-capable) to ABiTEP GmbH, commissioning in autumn
- 2016
Participation in the BMWi ZIM cooperation network "UseCO2" (CO2 utilization as a raw material)
- 2017
Extension of the "UseCO2" network for another two years; lecture "Bioreactor systems on demand" at BioBilanz
- 2021
Relocation on 8.11.2021 to the Adlershof technology park, Ernst-Lau-Strasse 5, 12489 Berlin