Day 2 :
G-CON Manufacturing Inc., USA
Time : 09:00-09:40
Maik W Jornitz, President of G-CON Manufacturing Inc., is a distinguished industry leader with close to 30 years of experience in bioprocesses, especially sterilizing gradernfiltration and single-use technologies, including regulatory requirements, integrity testing, systems design, and optimization. He has published multiple books, book chaptersrnand over 100 scientific papers. He is a member of the PDA Science Advisory Board, Marketing Advisory Board and Audit Committee, as well as an advisory board memberrnof Artemes Technologies, Biotechnology Industry Council and multiple science trade journals. He received his MEng in Bioengineering at the University of Applied Sciencesrnin Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland.
Over the last few years, biopharmaceutical-processing platforms moved from rigid traditional stainless steel to flexible singleuserntechnology. The platforms created the ability to run the process more efficient and with higher agility. The need to evolvernfrom fixed and rigid to flexible and agile systems did not stop with processes, but now shifted focus to facility designs. Traditionally,rnthe facilities built were product dedicated, large if not convoluted and involved lengthy time-to-run periods. To build such facilitiesrnthorough planning is required, especially capacity planning since the inflexibility of the structure does not allow easy scalingrnof the cleanroom space required. Overall, these types of manufacturing systems do no accommodate the need for flexibility ofrnscale, multi-product purposes, neither the benefits of single-use technology processes. Therefore, new facility systems are beingrnintroduced into the industry, ones that can be scaled, easily deployed and moved, if necessary. Prefabricated clean-room unitsrnnow replace so-called flexible modular structures, which did not show the necessary flexibility. These units are built off-site in arnfew weeks and moved into the shell building erected parallel to the manufacture of the clean-room units. Such structures creaternflexibility, scalability, and moreover, re-purposability. However, the cost comparison of these units versus traditional panel builtrnrepresents the same comparison as apples and oranges. The total cost ownership requires to be applied to determine, which facilityrndesign tool in the tool box is best for the specific project.