Biotech
Over the years, NE has been an integral part of the biologics revolution. From the first insulin treatments to today's breakthrough technologies in gene and cell therapy, tissue engineering and transgenic products, NE continues to deliver innovative and creative solutions for our customers.
NE services featured in:
Establishing compliant, cost-effective facilities
Building versus buying
Delivering high stakes revamp
Flexible, fast, modular
Get strategic with single-use technologies
Next generation biotech facilities
Single-use technology catalogue
Yield increases create new bottlenecks
200 percent increase through bioprocess optimisation
Automated approval of chromatography runs
Plasma fractionation
Challenges in advanced therapy facilities
Project References
Gene/Cell Therapy
Having performed many CAR-T and cell and gene projects globally, NE will leverage this knowledge and practical experience by focusing on the success factors from previous projects for our Customers:
Product contamination and Mix-ups
Crossing Flows
Differential pressure regimes
Jumps in GMP room classifications
Lack of dedicated janitors in cleanrooms
Reuse of utilities (pipes & equipment)
Equipment and surfaces are not cleanable or easy to maintain
GMP in combination with containment/Biocontainment
Facility & Building Monitoring Systems
Project References
OSD
With more than 24 years of experience in Oral Solid Dose(OSD), NE has the know-how and resources to help customers meet the challenges of increasing demand and competition for OSD products. Leveraging our experience, we help you optimise productivity and cost-effectiveness by providing engineering and consulting services related to facility, process and automation and IT, including:
Flexible multipurpose facility design, including: horizontal and gravity flow concept with closed systems, containment facility concept
Technology transfers
API containment risk assessment
High-potency API containment strategies
Containment equipment solutions
Achieving the best balance between investment and running costs
Increasing capacity and flexibility without disrupting the ongoing production
Process mapping
De-bottlenecking
Product and process optimisation and process development
Optimisation of packaging and logistics
Manual or fully automated material handling, including full integration from receiving to shipping area and integration of automated warehouses in the production
Optimisation of material and personnel flow
Transfer of automation strategies, including mapping of production processes and design
Protection strategies for operators and environment
Continuous manufacturing
Chemical synthesis processes
Project References
Lab
Laboratories is an integral part of modern pharma facilities and a part of the pharma value chain. NE works closely across architectural and engineering disciplines to deliver optimised and efficient quality control and research operations that meet the needs for flexibility, long-term capacity and regulatory compliance. Our specialist skills include:
Quality control laboratories
R&D laboratories
In-vivo facilities
R&D facilities
Small-scale production facilities for personalised medicine
Multipurpose laboratories and vivariums to support multiple products
Laboratories are key for pharma and biotech companies, from basic research, through drug development to the final quality control of production batches. Drug development and quality control require laboratories that are in GMP compliance. If the substances include biological agents or genetically modified organisms (GMOs), the laboratories must in addition comply with biocontainment requirements and have a carefully planned and functional design.
Personalised medicine changes the games in healthcare. This kind of medicine in its most personalised form, i.e. cell- and gene therapy using the individual patient’s own stem cells as the raw material, poses a number of challenges. NE has been working with the customers by supporting their establishment of the facility.
Project References
Medical device
Medical devices play a huge role in many different healthcare settings. they are crucial in patient treatment and diagnostics.
Although medical devices are immensely diverse, they still require some common areas of expertise. NE has been the in-house engineering and consulting partner of Novo Nordisk since the early medical device days. The services is expand to other area of products e.g. IVD and our famous customer includes Roche Diagnostics, Siemens etc.