Next generation single-use bioreactors support industrialization of new biotech therapies
New bioreactor designs have been critical to the success of biotech drugs reaching markets fast. Probably the most significant impact has been seen from the use of single-use bioreactors as an alternative to cleanable, re-usable systems. Single-use components have allowed for increased manufacturing flexibility, enhanced sterility assurance and reduced capital investment, as well as faster start-up of new facilities.
With the industry looking for ways to further intensify the production processes, the main challenge for single-use bioreactors is how to support high cell-density cell cultures in terms of aeration, mixing and mass transfer. In addition, the process controls and automation should allow for not only traditional batch processing, but also fed-batch, and even perfusion processing profiles; ideally, integrated with cell clarification and cell retention technology solutions.
Even though single-use technologies have brought the simplicity of eliminating cleaning and cleaning validation, they remain a source of operator errors and contamination risk, if the handling of especially larger systems is not well thought out. The ergonomics of installing single-use bioreactors and ancillary single-use systems into support hardware is an important concern for many users, which can be addressed through careful bioreactor design.
Pall offers a complete range of scalable, single-use bioreactors for process development and cGMP manufacturing. Whether you are growing adherent or suspension cells for gene therapy, cell therapy, vaccine or monoclonal antibody (mAb) manufacturing, at small or large scale, we have the right technology for you. Our expert team will help you choose the most suitable bioreactor solution and will support you with getting your process up and running in no time.
Key features of Pall’s upstream portfolio include:
- Ease of use: ergonomic bioreactor designs with intuitive software, semi-automated bioreactor inflation, integrated tubing management and labeled connections reduce operator errors
- Integrated with Pall’s broad portfolio of award-winning technologies
- Global support service: experts support you during process development, process design, as well as during equipment installation, qualification and maintenance
- Meets latest quality and regulatory requirements
- Extensive documentation, validation and application data is available
Process Development Scale
Small cGMP Batches
Large cGMP Batches
|Suspension Cell Culture|
|Recombinant Protein, Monoclonal Antibodies (mAbs), Gene Therapy||Allegro™ XRS 25 Bioreactor System: for high cell density cell culture of mammalian cells, and for insect cell culture; from 2 to 25L|
|Allegro STR Single-Use Stirred Tank Bioreactor Family: scalable single-use bioreactor family, from 10L to 2000L; applications include mAbs, gene therapy and adherent cells grown on microcarriers|
|Adherent Cell Culture|
|Gene Therapy, Cell Therapy||iCELLis® Nano Bioreactor: for virus production from adherent cells for gene therapy and vaccines||iCELLis® 500 + Fixed-Bed Bioreactor: for virus production from adherent cells for gene therapy and vaccines|
|Xpansion® Multiplate Bioreactor System: intensified and controlled growth of adherent cells for cell therapy or as a seed train for the iCELLis® bioreactor|