Single–Use Technology: Roadblocks On the Way
Process characterisation and standardisation of single-use systems are still inadequate both in upstream and downstream processing. Other limitations of single-use systems apply to pressure, flow rates, centrifugal force, temperature and O2/CO2 stripping 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, employee training, quality assurance and production flows, all of which have to start back in the development phase.
However despite all of that, the products which are already available on the market, when used and handled properly, provide a route to smaller, cheaper, greener, 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, particularly in upstream processing.
Huge Potentials for Single–Use Technology in Vaccines Production
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 (especially contract manufacturers) deploy single-use systems wherever possible. The list of companies in the German speaking region includes Baxter Austria, Boehringer Ingelheim (Germany), Hoffmann La-Roche Germany and Switzerland, Merck Serono Germany and Switzerland, Novartis Switzerland and Austria, Rentschler and Werthenstein BioPharma.
Hybrid Production Systems for Biotechnology and Pharmaceutical Industries
As a general rule, hybrid production systems are still the norm at these companies. Single-use systems are combined with conventional systems made of glass or stainless steel. However, plans are in place to introduce production lines that are fully based on single-use systems. Global developers and manufacturers are included in the general trend towards single use systems. GE Healthcare, Merck Millipore and Sartorius Stedim Biotech currently have the largest portfolio. However, a lot is going on in development and production. Some new players are entering the market, but experts expect that market consolidation will set in over the coming few years. Companies, which have a broad product portfolio and are able to guarantee user support for the entire process, will have an advantage.
Layout, Handling and Disposal – Challenges to Overcome
Facility layout, handling and disposal pose the biggest challenges – when users migrate to single-use systems. Facility layout is driven both by company standards and regulatory requirements. The potential risk of active ingredient contamination is the primary consideration. The quality of the cleanroom design and the associated HVAC systems have to meet stringent standards. Besides the size of the up-front investment, the ongoing operational cost factor is anything but trivial.
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