From new drug candidates and predictive cell culture models to development and manufacturing of innovative (bio-)pharmaceuticals to nanobiomedical applications.
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.
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
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.
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...