August 1, 2013
NNE Pharmaplan has developed a new facility concept called Bio on demand™, which enable facilities to be established in one to two years. The result is a flexible facility that is fully operational and locally compliant, with functioning quality systems. Bio on demand™ involves a high degree of single-use technology to ensure cost-effective production and fast establishment.
Facilities based on our Bio on demand™ 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
Bio on demand™ 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. Also, the customer gains better predictability of the project 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. Based on 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 a number of ways to accommodate all the functions in a modern biotech facility and meet the need for flexibility and adaption to local building and 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 demand™ concept enables fast-track project execution with parallel execution and single-use technology that decouples building from process to allow late freeze of 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 good manufacturing practice (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 the world’s leading engineering and consulting company in the complex field of pharmaceuticals and biotechnology. We cover all segments from biopharmaceuticals and vaccines to medical devices and help our customers develop, establish, and improve their product manufacturing. NNE Pharmaplan employs 1,700 people at more than 30 locations around the world.
To learn more about our company and our Bio on demand™ facility concept, please visit nnepharmaplan.com.
About the Author
Author Details
Niels Guldager is senior technology partner of biopharmaceuticals at NNE Pharmaplan, Nybrovej 80, 2820 Gentofte Denmark, 45-3079-7246; [email protected].
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