Cell and gene therapies (CGT) is a fast-growing product segment in pharma. And for manufacturers, the new product types are raising a lot of questions concerning everything from the strategic direction to daily operations. NNE’s experts can help you answer all these questions, e.g.
- Should you make or buy production capacity?
- How do you ensure compliance with regulatory expectations?
- How do you move from development to industrialization?
- What are the considerations for automating CGT production?
- How much capacity should you design for?
- What does it take in terms of time and cost to build a CGT facility?
We have more than 30 people with in-depth knowledge within the area of CGT, covering expertise within compliance, process, automation and project execution. Our cross-disciplinary cooperation means that we can deliver integrated and customized engineering and consulting services to help you succeed with CGT.
Solving your CGT challenges
At NNE, we have more than 30 people with in-depth knowledge within the area of cell and gene therapies, covering expertise within compliance, facility, process, automation and project execution. Our cross-disciplinary cooperation means that we can deliver integrated and customized engineering and consulting services to help you succeed with CGT.
Making the right strategic decisions
Investments into advanced therapy medicinal products come with high risk. Making the right decisions at the right time can be a game changer. NNE can help you with feasibility studies (basis for decision) and provide high level cost estimate, project schedule estimate as well as initial facility and layout requirements.
Building your business case
How much does a new facility for cell and gene therapy cost? How long does it take to design it, build it and test it? And what are the project and business risks? NNE’s experts can help you answer all these questions. We can prepare a feasibility study (basis for decision) or a conceptual brief/design (basis for design) to help you clarify if you should pursue the opportunity of building a facility or do something else. We can also help establish what your ideal manufacturing setup is and how much capacity you will need.
Ensuring GMP compliance
Cell and gene therapies are vastly different in nature from traditional pharma products – and consequently so are the regulatory requirements. For many manufacturers the GMP regulations for ATMPs seem like a moving target. One of the challenges is how to be sure the product is safe if it is not following the traditional clinical phases with a high number of clinical test persons. NNE’s compliance consultants can support you with GMP advice and review to ensure that your cell and gene therapy facility and production live up to regulatory expectations.
Transforming your process
Our process experts help customers design and evolve first generation process operation to ensure robust results. Our single-use technology specialists ensure an operationally friendly design for your facility, no matter the scale. We combine best practice solutions from all suppliers for an optimal design. We can help youtake your manual process solution within cell and gene therapy to the next level and lift quality and compliance to meet the highest regulatory standards.
Automating cell and gene therapy manufacturing
Automation process steps for cell and gene therapies pose several challenges. For instance, your current process control system or built-in programmable logic controller may not be compatible. And what about 21 CFR Part 11 compliance – how do you handle that when each patient represents one batch record? How do you ensure sufficient traceability to avoid cross contaminations, mix ups, etc.? NNE’s automation experts can help you create a robust automation and IT strategy.
Accelerate industrialization of your cell and gene therapy
Unsure how to bridge the gap between R&D, tech transfer and commercial manufacturing?NNE can provide you with a roadmap that empowers you to make the right technological decisions to maximize yields, cost of goods sold, logistics, automation by analytics, etc. With the right expertise, it is possible to achieve operational excellence by designing a facility of the future with today’s technology.