Applications of Single–Use Technology in New Fields
Growth in the market for disposable systems (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 of course the availability of qualified staff),” reported Prof. Regine Eibl from Zurich University of Applied Sciences (ZHAW).
We will probably also see new applications of single-use bioreactors, such as – in the production of microbial niche products; for production methodologies involving algae; and for products in the pharmaceutical, food and cosmetics industries that are based on plant suspension cells, hairy root cultures and mesenchymal tissue. “A large number of 100 per cent SUS-based implementations of fermentation processes involving animal cell cultures are already established, and more are on the way,” said Detlef Eisenkrätzer from Roche.
Biotherapeutics – The Future of Single–Use Technology?
The latest generation of biotherapeutics will have a decisive influence on the future development of single-use technology. Eibl is convinced that personalised 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 is generally regarded as a major product segment in personalised medicine. Products for regenerative medicine (skin, cartilage and bone) have been making their way into the market since the 1990s, and the first customised (patient or person specific) vaccine for treating prostrate cancer received FDA approval in April 2010. Compared to established biopharmaceutical manufacturing techniques for protein therapeutics, even today cell therapy is in its infancy. Innovative equipment and new technologies will be absolutely essential for commercial success.
Given the product requirements and the way the products are used, there is no alternative to single-use systems. 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.
* Source: DECHEMA ad-hoc Single-Use Technologies Working Group Courteously of PROCESS India