QBDC provides GMP expertise for a BMBF Project to develop a GMP-compliant DoE Software for optimizing biotech processes
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QBDC GmbH has been recruited as an advisor on GMP topics for a BMBF project by the Hamburg University of Technology (TUHH). A consortium around Prof Ralf Pörtner (l.) and Johannes Möller (r.) of IBB at TUHH develops a novel DoE Software for improved process development in the biotech industry.
The development and optimization of bio-based products in general is still strongly empirical. Often, lengthy and specific Design of Experiment (DoE) methods are required, which lead to a large number of time-consuming experiments. The conception, particularly the limitation, of the experimental space is difficult, and the validity is often limited.
The focal point of the BMBF project is to develop modular software tools that combine DoE strategies with mathematical process models, thus, significantly reducing the experimental effort and increasing validity and applicability of a DoE. Applying GMP regulatory rules from the onset of development and later implementation of the GMP-compliant software facilitate the passage towards regulatory acceptance and eventually approval of developed and validated processes for the biotech-pharma industry.
“This project is the inception of a new concept for process development software, with combined modelling, DoE simulations, and finally applying control strategies directly onto process control systems. It decreases development periods, increases process robustness and ensures simple process transfers via its process control interface”, explains Prof Pörtner of TUHH. Johannes Möller concludes, “we will validate the software together with our partners, Prof Hass from HS Furtwangen and Prof Frahm from HS Ostwestfalen-Lippe in White and Green biotech industry and aim to implement our strategies eventually into the Red.”
About Technical University Hamburg, Prof Ralf Pörtner
Prof Ralf Pörtner, head of the Research Group for Animal Cell Culture Technology at Institute of Bioprocess and Biosystems Engineering (IBB, head: Prof Dr An-Ping Zeng) at TUHH, is highly recognized in the Pharmaceutical and Biotech Industry, with numerous publications in scientific magazines and authoring several books.
The working group of Prof Pörtner deals with concepts for model-assisted design, control and regulation of bioreactors for biotechnological production processes. Recently, the research focuses on linking methods of statistical Design of Experiments with mathematical process modeling in order to establish new, time-saving and cost-effective development strategies. An essential aspect of the work is the implementation in industrially relevant processes. Currently, the projects are funded by the DFG, BMBF and BWF Hamburg.
QBDC is a Switzerland-based, internationally active bio-pharma consultancy company with the focus on interface management. They present themselves as experts in building “bridges”, which shall facilitate the passage across technological, and cultural gaps, and they provide aide in constructing strong and sturdy GMP foundations.
Their vast experience in various biotech topics allows them to help their customers recognizing and addressing risks before they become severe, help them being prepared for looming challenges, and help them optimizing their workflows to reduce time and costs.
QBDC provides solutions for:
- CMC topics (biosimilars, ATMPs, NBEs, various cell lines, media engineering, cell culture design/optimization),
- Scale-up and tech transfer (“translate” processes to larger scale/to 3rd parties both as sender and receiver),
- Facility layout and design (design and layout from scratch, optimization and qualification of existing facilities),
- QC & QA (GMP compliance, data and document management solutions METIS and TEMIS); and
- Project management (aide in transitional phases, business planning, assess 3rd parties for potential collaborations)
QBDC Press Release, 18-04, 13.07.2018, Nusshof, Switzerland
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