NNE Pharmaplan has developed a new facility concept called Bio on demandâ„¢, which enables facilities to be established in one to two years. The result is a flexible facility that is fully operational, locally compliant, and contains functioning quality systems. Bio on demandâ„¢ involves a high degree of single-use technology to ensure cost-effective production and fast establishment.
Facilities based on our Bio on demandâ„¢ concept can be delivered globally, but they are primarily intended for growth markets where time-to-market is particularly essential.
Full Package for Full Predictability
The Bio on demandâ„¢ concept includes engineering and supply of a facility as well as related quality systems, standard operating procedures, and coordination of necessary quality tests.
When executing a project, NNE Pharmaplan’s overall objective is that the customer develops new capabilities and grows existing ones. And by not only providing a facility but also a full turn-key solution, we allow our customers to focus on creative aspects rather than technicalities. That is essential to accomplishing expected benefits and contributing to strategic objectives and visions. Customers also gain better predictability of projects and future production.
High Flexibility for Customized Solutions
Bio on demand™ is a standard concept that can be adapted to individual customers’ needs and for local and site-specific conditions. With our Bio on demand™ facility concept, we can build facilities on site in the traditional way or off site as a modular facility, depending on the customer’s preferences. Standardized process and utility modules are combined in various ways to accommodate all functions in a modern biotech facility and meet the need for flexibility and adaption to local building and good manufacturing practice (GMP) regulations and practices. The concept is adaptable for a wide range of business cases and commercial possibilities.
Accelerated Timeline for Speed to Market
Our Bio on demandâ„¢ concept enables fast-track project execution with parallel execution and single-use technology that decouples building and process to allow late freeze of the process. Verification is based on ASTM E-2500, which ensures speed and cost effectiveness. The overall focus is on integration of activities related to first GMP batch for a timeline target of only 18 months from finished basic design to the start of the first GMP batch.
Who We Are
NNE Pharmaplan is a leading engineering and consulting company within the life-science industry. We work with some of the world’s most prominent pharmaceutical and biotechnology companies to help them develop, establish, and improve their manufacturing and ensure regulatory compliance. NNE Pharmaplan employs about 2,000 people at more than 25 locations around the world. Engineering for a healthier world is our role in an industry that improves people’s lives worldwide.
To learn more about our company and our Bio on demandâ„¢ facility concept, please visit nnepharmaplan.com.
Niels Guldager is senior technology partner of biopharmaceuticals at NNE Pharmaplan, Nybrovej 80, 2820 Gentofte Denmark, 45-3079-7246; ngu@nnepharmaplan.com, www.nnepharmaplan.com.