Reports and position papers

Current positions on topics of chemical technology, biotechnology, education and interdisciplinary issues

Pharmaceuticals

2019

Recommendation for biological evaluation of bioreactor performance for microbial processes

(September 2019)

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".

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2018

Status Paper "Facility of the Future"

(March 2018)

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.

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2017

Phytoextracts - Proposal towards a new comprehensive research focus

(July 2017)

In order to meet the growing demand for and exploit the potential of phytoextracts for food, pharmaceutical or agrochemical applications, a coordinated research approach with adequate public funding is mandatory. In its current position paper “Phytoextracts – Proposal towards a new and comprehensive research focus”, the ProcessNet sub-division “Phytoextracts – Products and processes” outlines the state of research and technology and gives recommendations for research targets and approaches

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2016

Recommendations for process engineering characterisation of single-use bioreactors and mixing systems by using experimental methods

(February 2016)

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).

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2015

Recommendation for a risk analysis for production processes with disposable bioreactors

(September 2015)

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.

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2014

Recommendation for Leachables Studies - Standardized cell culture test for the early identification of critical films

(January 2014)

Today, single-use technology is used routinely in biopharmaceutical development and manufacturing processes. Besides many advantages, the available single-use systems still have limitations. One of the most cited disadvantages is the risk for release of potentially toxic or inhibitory substances, so-called leachables from the plastic bags. The bags are typically made of multi-layer thermoplastic films. Until now, no standardized cell culture test was available to identify critical bag films at an early stage in process development. To meet this need, a sub-team of the DECHEMA temporary working group "Single-Use Technology in Biopharmaceutical Manufacturing" developed a standardized cell culture test that would enable the early identification of non-satisfactory films for cultivation of CHO cell lines in chemically defined culture media.

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2012

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