Project References

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.


Project References