Verfahrenstechnik Production in a plastic bag

The number and variety of single-use systems available on the market for biopharmaceutical R&D and production applications has increased steadily over the past ten years. For upstream processing users today can choose from a large selection of products provided by a whole range of suppliers. The range of options includes bioreactors which use wave motion to mix materials (from GE Healthcare and Sartorius Stedim Biotech) as well as single-use stirred bioreactors available in a variety of versions. Similar systems for downstream processing are not as significant a factor as the upstream systems. The basic downstream processing steps used in the production of biopharmaceutical products include conventional filtration and chromatographic techniques as well as recent developments such as functional filtration/absorption and mixed-mode technologies. Process characterization and standardization of single-use systems are still inadequate both in upstream and downstream processing. Others limitations of single-use systems apply to pressure, flow rates, centrifugal force, temperature and O ₂/CO ₂stripping rates. The list of constraints also includes the limited set of leachables and extractables, size limits, the higher cost of consumables, security of supply issues and the current lack of automation sensors. In addition, successful implementation of single-use technologies also depends on changes and new approaches to system design, quality assurance and production flows, all of which have to start back in the development phase. Despite all of that, the products which are already available on the market, when used and handled properly, provide a route to smaller, cheaper, safer and faster development and production. That undoubtedly explains why these systems have established a firm foothold in all of the main process steps found in small to medium scale production of biopharmaceuticals and biosimilars. They reduce development cycles and time to market for new biotherapeutics such as antibodies and veterinary and human vaccines. “Especially in vaccine production, we believe that the applications potential is very significant: small volumes, batch production, flexible production requirements and cross-contamination risk. This is an area where single-use technologies can show their strengths,” claims Dr. Karsten Behrend from M+W Process Industries. The majority of biotherapeutics producers deploy single-use systems wherever possible. The list of companies in the German speaking region includes Baxter Austria, Boehringer Ingelheim, Hoffmann La-Roche, Merck Serono, Novartis, Rentschler and Werthenstein BioPharma. Growth in the market for disposable systems which are used in the production of protein-based therapeutic products can be expected to slow down. However if development work continues, the products needed for complete single-use production systems and the “single-use factory in a box” will become closer to reality. “There is already a vision for an SUS container-based vaccine factory which can be shipped anywhere in the world in a very short space of time to produce vaccine - assuming the availability of qualified staff,” reported Prof. Regine Eibl from Zurich University of Applied Sciences. We will probably also see new applications of single-use bioreactors in the production of microbial niche products, for production methodologies involving algae and for products in the pharmaceutical, food and cosmetics industries which are based on plant suspension cells, hairy root cultures and mesenchymal tissue. Eibl is convinced that personalized medicine, especially the production of cell therapeutics using stem and T cells, is likely to be one of the most promising future applications of single-use technology. Cell therapeutics are generally regarded as a major product segment in personalized medicine. Products for regenerative medicine (skin, cartilage and bone) have been making their way into the market since the 1990‘s; the first person-specific vaccine for treating prostrate cancer received FDA approval in April 2010. More than 200 cell therapeutics for transplant medicine, cancer and aids therapy are currently at the clinical trial stage. This is a great opportunity not only for the medical field but also for single-use technologies.