From new drug candidates and predictive cell culture models to development and manufacturing of innovative (bio-)pharmaceuticals to nanobiomedical applications.
Production, analytics & regulatory aspects of advanced therapy medicinal products
The Subject Division Plant based Extracts - Products and Processes of ProcessNet (an initiative of DECHEMA – Society for Chemical Engineering and...
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.
> Download programme as PDF Enzymes are considered to be little miracle substances for innovation, process advantages and cost...
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.
ALEXANDER - Mucus Permeating Nanoparticulate Drug Delivery Systems - was a large-scale collaborative research project within the 7th European Framework Programme for Research and Technological Development. The project ran from April 1, 2012 to March 31, 2016.
Within ALEXANDER, 14 partners from industry and academia have joined forces, combing leading expertise in chemistry, biochemistry, pharmacy, chemical engineering, pharmaceutical technology, molecular physiology, biopharmaceutics, toxicology, drug development and project management.
Kreysa, Gerhard / Schütze, Michael (Hrsg.) Corrosion Handbook - Corrosive Agents and Their Interaction with Materials Volume 11: Sulfuric Acid Corrosion...