From the inventory of a cell by –omics to synthetic biology, from strain development to industrial biotechnological processes including downstream processing
With the new status paper “Schedule Risk Analysis for Capital Projects – A Practical Guide”, the DECHEMA/VDI Working Group Cost Engineering presents a practical guide that provides professionals from the process, chemical, and plant engineering industries, as well as project managers in operating companies, with concrete recommendations for systematically identifying, assessing, and managing schedule risks in capital projects.
In this paper, the DECHEMA/VDI Working Groups Cost Engineering and Modular Plants provide devinitions, evaluation criteria and examples for the economic and qualitative evaluation of different construction concepts.
The DECHEMA position paper describes the effects of miniaturization, automation and digitization on laboratories and the development of biotechnological processes and products. The authors recommend to focus on the convergence of these trends to exploit their full potential.
This supplement to the recommendations for process engineering characterisation (2nd edition, published December 2020) provides experimental methods for a further important parameter, the kLa(CO2).
These recommendations provide suitable experimental methods for the process engineering characterisation of single-use bioreactors and mixers.
2. revised edition
The Escherichia coli model process described in the recommendation also makes it possible to characterise the biological performance of a system. The standardised process aims to determine the performance of bioreactors, in particular single-use bioreactors, and to evaluate their suitability for microbial applications. Since microbial processes place high demands on the bioreactor system with regard to oxygen transfer, this is of particular importance; another important parameter is heat removal.
The associated Excel tool offers the possibility of a standardised evaluation, so that a comparison across bioreactor systems is possible. Calculations, e.g. of the volumetric mass transfer coefficient, will be performed automatically after input of the raw data.
Recommendation and Excel tool were developed by the "Single-Use Microbial" working group of DECHEMA's expert group "Single-Use Technology in Biopharmaceutical Manufacturing".
The biopharmaceutical industry has developed rapidly in recent decades, with biotechnologically manufactured drugs are at the top both in new approvals and new fields of application. Various trends such as the production of biosimilars have led to a real boom in new production facilities in recent years.
Pharmaceutical companies are increasingly planning and constructing more flexible, smaller plants to meet the demand. These flexible Facilities of the Future (FoF) often use single-use systems. The Status Paper of the DECHEMA working group “Single-use technology in biopharmaceutical manufacturing” is an introduction in the field.
Geobiotechnology does not only contribute to the remeditation of soil and mining waters. It offers also significant potential for the exploitation of resources from primary deposits as well as tailings and heaps and for recycling. The status paper by the Temporary Working Group Geobiotechnology gives an overview on the current status of research and technology and discusses perspectives for the further development. Relevant stakeholders in Germany and educational courses are also listed.
These recommendations of Working Group Upstream Processing of the DECHEMA expert group “Single-use technology in biopharmaceutical manufacturing” aim to select suitable experimental methods for the characterisation of single-use bioreactors (SUB) and mixers (SUM). The described methods are applicable to a broad range of of single-use systems and applications. The guidelines can also be used for the engineering characterisation of reusable systems. Furthermore, these process engineering characterisation methods intend to offer manufacturers and operators of SUB and SUM a uniform set of methods and instruments through validated Standard Operating Procedures (SOPs).
New production systems and innovative manufacturing methods such as single-use technologies bring about new challenges for quality control of biopharmaceutical production processes. In its most recent publication, the DECHEMA Working Group “Single-use technology in biopharmaceutical manufacturing” gives recommendations for a risk analysis of these processes. Based on prior publications, the compact paper lists the regulatory background as well as potential risks related to material, processes, or products. An example of an industrial application shows how risk values can be defined and risk levels calculated in order to determine appropriate countermeasures. This recommendation is based on an article in Adv. Biochem. Eng. Biotechnol. The original publication is available at www.springerlink.com.