Every process is different. Not the platform.
For CDMOs, flexible upstream platforms can help streamline process development while maintaining reproducibility and continuity across scales.
When every client process comes with its own demands, contract development and manufacturing organizations (CDMOs) need upstream bioprocessing solutions that are flexible and make process development more efficient and reproducible. Teams must develop a thorough understanding of each process, reproduce performance across scales, and establish a clear path to production, often within demanding timelines.
Orchestrated hardware and software tools increase process development efficiency
The Eppendorf upstream bioprocessing solutions combine scalable bioreactor systems with process automation and software tools for monitoring, control, and analysis. These solutions can help teams to
- Identify critical process parameters more quickly and understand how they influence product yield and quality
- Tailor process control to meet the specific needs of the cell type of interest
- Automate process control, sampling, and data management to save time and reduce manual work
- Transform experimental results into actionable process knowledge
Platform continuity simplifies technology transfer
The Eppendorf upstream bioprocess solutions can support a process from research and development through clinical and commercial manufacturing. They help teams:
- Reduce variables by maintaining a consistent bioprocess platform when scaling up from R&D to bench-scale manufacturing
- Reduce user training requirements by using the same bioprocess platform across scales and for various cell types
The BioBLU® Single-Use Bioreactor portfolio covers cell culture working volumes from 100 mL to 40 L in the same rigid-wall design. The bioreactors can be operated with a single benchtop controller and a consistent software environment. This allows the same vessel geometry and process control strategy to be applied across scales, reducing equipment-related variables and simplifying technology transfer.
The process can continue beyond research and development: BioBLU HNQ Single-Use Bioreactors and the
BioFlo® 320 plus bioprocess controller are suitable for clinical and commercial manufacturing and are offered with Validation Guide to support equipment qualification for manufacturing applications. The Eppendorf platform for biopharmaceutical manufacturing is completed by DASware® control plus SCADA software, which is compatible with 21 CFR Part 11 and EudraLex Volume 4 Annex 11.
Explore eBooks to tackle your process challenges
Explore practical insights into common process development challenges and see how Eppendorf can support your work. Learn more about maintaining comparable cell growth and yield during process scale-up, turning bioprocess data into informed process decisions, and optimizing cell therapy bioprocesses. Download the eBook that best matches your current project needs at: https://eppendorf.group/rz5lmcno
Contact
Eppendorf SE Bioprocess Center
Rudolf-Schulten-Str. 5, 52428 Juelich, Germany
Tel: +49 2461 980-400
Email: bioprocess-info(at)eppendorf.de
Internet: www.eppendorf.com/bioprocess
This article is sponsored by Eppendorf.
