NNE’s cross-disciplinary competencies and GMP experience, makes us a strong partner for pharma companies wanting to implement continuous processing. Continuous manufacturing impacts not only the process, but also facility, automation, validation and organization. NNE combines experience in all these areas and can help you:
- Develop your continuous processing setup to match your production needs
- Design/redesign your facility to accommodate continuous manufacturing
- Establish automation solution to ensure maximum efficiency
- Ensure compliance with GMP, ASTM and other regulatory guidelines
- Develop an operating model to support continuous manufacturing
We integrate all these aspect into a holistic, robust solution to help you smoothly implement continuous manufacturing. The ideal outcome is linking the entire production flow, from cell expansion to packaging, into one continuous flow.
Unparalleled experience in continuous bioprocessing
NNE is the de facto global leader in design and engineering for industrial scale continuous bioprocessing. We have designed, built and brought online several landmark continuous process biotech facilities over the last 30 years. Our facility project track-record and hands-on experience with continuous bioprocessing is unmatched in biotech engineering.
Our practical experience means that we know and understand the realities of continuous bioprocessing. And we apply this deep understanding to offer our customers the support they need when designing and industrializing the next generation of continuous bioprocessing facilities.
Building the business case for continuous manufacturing
Many manufacturers are currently doing development work on CP and looking into industrialization of the technology. NNE sees it as our prime task to support companies in this effort and help them build a solid foundation for making the right strategic decisions. We provide guidance to companies to help them evaluate their operations and prepare for potential use of continuous technologies, by:
- Assessing whether continuous manufacturing is feasible
- Building a solid business case
- Evaluating product risk and process risk
- Developing a process control strategy
- Building an implementation strategy
- Creating a logistic control strategy
Our goal is to help our customers build the confidence to move into the next phase of a continuous manufacturing project.