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Biotech and active pharmaceutical ingredients

Biotech pipelines are booming with new products and treat¬ments calling for flexible and efficient processes. Establishing and maintaining fully compliant and cost-effective manufacturing capabilities is as challenging as ever.

Biotech, and particularly the field of biopharmaceuticals, has been growing fast and will constitute more than 50% of the pharmaceutical drug market by 2020.

Biopharmaceuticals include a broad range of product types requiring different production technologies. Most manufacturing methods utilise either microbial or mammalian expression systems, but other systems are utilised for specialised products such as vaccines. Additionally, the industry is facing new challenges, based on the introduction of new and even more complex products such as antibody-drug conjugates (ADC), which require facilities that are capable of handling biologics and potentially very potent (toxic) small molecule products in the same facilities.

As such, the industry is moving away from a state of stable development of biopharmaceutical products for especially diabetes (insulin), cancer, arthritis (monoclonal antibodies) and other special diseases. The next generation of biopharmaceutical products require more complex manufacturing methods. A large portion of the products, e.g. orphan drugs or immunotherapy, is produced in much smaller quantities. Moreover, many existing facilities are more than 20 years old, making them overdue for an upgrade to meet both current and future requirements.

Full lifecycle support to biotech/API manufacturers

Our support covers the complete lifecycle of the product from the initial idea to optimising the operation of established commercial manufacturing facilities. This includes applying our manufacturing experience into facility design, based on a combination and in-depth knowledge within process, quality, facility, automation and physical project delivery.

For more than 80 years, NNE has helped customers manage challenges related to biopharmaceutical production, e.g.:

  • Making the right manufacturing decisions based on thorough analysis of a broad range of options
  • Establishing compliant, cost-effective development and manufacturing facilities
  • Project management ensuring successful project execution on time and within budget
  • Revamps of running facilities, where downtime has to be minimal
  • Supporting flexible, fast and modular manufacturing
  • Preparing for future changes in the product portfolio
  • Safe and controlled introduction of new technologies
  • Preparing for seamless audits
  • Applying industry standards for qualification and validation activities
  • Strategies applying the right level of automation
  • Implementing effective quality control systems
  • Implementing product quality focused control strategies 
  • Supporting cost-effective and compliant daily operation

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