Reports and position papers

Recommendations for process engineering characterisation of single-use bioreactors and mixing systems by using experimental methods
Supplement to the 2nd edition: Volumetric mass transfer coefficient of CO₂

(October 2021)

This supplement to the recommendations for process engineering characterisation (2nd edition, published December 2020) provides experimental methods for a further important parameter, the k_La(CO₂).

Recommendations for process engineering characterisation of single-use bioreactors and mixing systems by using experimental methods (2nd Edition)

(December 2020)

These recommendations provide suitable experimental methods for the process engineering characterisation of single-use bioreactors and mixers.

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".

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.

Geobiotechnology - Status and Prospects

(September 2017)

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.

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).

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.

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.

Report Of The Temporary Working Group: Single-use Technology in Biopharmaceutical Production

(March 2012)

En Route to the Knowledge-Based Bio-Economy - Cologne-Paper

(May 2007)

Renowned experts from academia and industry were invited to contribute to an expert paper which outlines the perspectives of a KBBE within the next 20 years. The resulting so-called 'Cologne Paper' was published on 30 May 2007 in Cologne on behalf of the German Presidency of the Council of the European Union.