Case Study: Structured Design of Biotech Plants

Dirk Steinhäuser, Glatt Process & Plant Engineering Pharma + Biotech and Vice Head of Glatt Ingenieurtechnik Dresden office, used a case study to provide an overview of the company’s structured and flexible planning approach for biotechnology projects.

The biotechnology industry is dynamically developing new products for pharmaceuticals, nutritional supplements, food and bio-based chemicals. These are usually to be produced very quickly, sometimes while product development and process development are still ongoing, already for market launch quantities and then quickly ramped up to large capacity. Fast and reliable scaling methods (scale-up) from laboratory to pilot scale to transfer to commercial production are crucial for the successful introduction and implementation of new product developments as well as for the conversion or capacity expansion of existing production facilities.

The presentation provides an overview of the structured and flexible planning approach of Glatt’s Engineering division for biotechnological projects, which can take on processes that are still in the final development, accompany and support them in terms of planning. If necessary, process steps for defining process parameters are also accompanied by tests in the pilot plant or at special manufacturers. The presentation addresses typical situations and problem areas and shows possible solutions for how to deal with process steps and parameters that have yet to be defined in relation to the definition of a planning basis and how they can be supported by technologists and planners.

The procedure is presented and discussed using selected project examples (case study examples) from Germany and abroad. Information is given regarding methodology and the interaction between process developers and planners, and lessons learned from various project examples are discussed.

• Inclusion of ongoing process development as a planning basis
• Structured approach for processes scaling phases
• Design principles, definition of critical parameters, flexibility
• Plant modules, layout typicals and supply structures
• Important success factors and challenges