NNE's drug delivery experts bring extensive experience from different corners of the drug delivery supply chain. That means that we can support you in all aspects of drug delivery to help you launch combination products with success. Our drug delivery team covers a broad range of competences and offers holistic drug delivery support services within the following areas:
- Primary container development
- Filling process development (including isolator, restricted-access barrier system, cleanroom)
- Medical device manufacture
- Packaging and serialization
Our drug delivery team work closely together with the rest of the NNE organisation to support our customers in everything from product development to establishment of pharma production facilities. Working with NNE means access to:
- Proven product result – extremely safe and effective medical devices for critical life sustaining drugs
- Superior execution capabilities
- Design control and risk mitigation
- CMO (contract manufacturing organisation) tech transfer and sustainment
- Supply chain development, improvement and sustainment
- Design improvement and refresh
This is generated by leveraging our core pharma and biotech engineering development experience to deliver best-in-class drug delivery solutions in an agile and proactive manner.
Integrating primary container, medical device and filling for robust solutions
The road to a robust drug delivery programme has three lanes: primary container, medical device and filling. Making sure that these three lanes merge into a robust supply chain is key to a successful drug delivery programme.
NNE is one of the few companies – if not the only one – that has hands-on experience within all three aspects. Our knowledge and experience enable us to support our customers with consulting and engineering services related to primary container, medical device and filling processing and with proficiently integrating the three aspects into one robust drug delivery programme.
As such, a wealth of consulting and engineering services to support your drug delivery programme:
- Development of project management models and technology development models
- Project portfolio management
- Tolerance chain analysis
- Front-end innovation: Human factors engineering/usability studies, user studies, idea generation, industrial design, concept development and selection
- General risk management consulting
- Design review
- CMO search and selection
- Mechanical design, CAD drawings
- Mould flow analysis
- FMEA analysis
- Design for manufacture
- Material selection and changes
- Device verification testing
Joint development with customers
At NNE, we want to be considered more than a trusted partner. Our ambition is to engage in joint endeavours with our customers in the development of new combination products. By joining forces, we can capitalise on both companies' knowledge and patient insight and achieve tailormade solutions that make you stand out in the market.
Based on decades of experience developing medical devices and combination products, we have developed our own design concepts, which can be adapted to individual customer needs and wishes. We even offer independent and tailored medical device testing in our own in-house laboratory.
Collaboration for robust products
A successful drug delivery programme integrates the requirements of a wealth of stakeholders from patient through manufacturing to distribution. In addition to the traditional project team meetings, we thus utilise a series of workshops to collect information from all relevant stakeholders. Workshops are a great platform for linking NNE's extensive experience in drug delivery with stakeholders from filling, packaging, production, marketing, human factors, R&D, regulatory, formulation, medical, etc., to understand the use scenario and drive the right product attributes. This information will be used to author concept requirements and later refine specifications.
We have seen over and over the importance of control in relation to product robustness. Therefore, we will:
- Follow your quality management system
- Follow your project governance structure
- Create documents and drawings based on your templates
Even after launch, we are there to help make design changes and improvements to help you sustain your combination product. NNE can manage your supply chain by providing moulded components and sub-assemblies including design history file, device master record, tech transfer, design and process verification and validation as well as sustainment activities.