While the single-use filtration systems and the scalable freeze/thaw platforms developed by SUSupport keep gaining traction on the international biopharma market (see news regarding the successful launch on the Indian market), SUSupport is preparing to strike again.
Though a relatively novel process, seed train intensification is quickly gaining traction globally with pharmaceutical companies and labs requiring cell cultures of different sizes for studies, personalized therapies and blockbuster production.
Last but not least COVID-19 and its challenges are currently accelerating the demand for new accelerated production processes in biopharma.
The term describes the process of how to intensify the inoculation and seed train in the so-called upstream of biopharmaceutical manufacturers at any scale by means of advanced technologies. While it is possible – and actually still quite common – to grow cell cultures using stainless-steel bioreactors, disposable single-use systems are steadily replacing the methods utilizing stainless-steel reactors. This seems only logical:
With their flexibility and scalability, single-use components are far better suited to cover the requirements of the process, which is based on the lean production principle.
Seed train intensification for upstream processes – At a very early stage of biopharma drug substance manufacturing, cells are being nurtured from 1 ml to the required amount, which can reach more than 2,000 liters. This takes approx. 5 weeks during which time there are many potential pitfalls in terms of sterility and appropriate cell perfusion. Seed train intensification offers a way to benefit from already expanded cells, thus circumventing a continuous restart with 1-ml vials.
„If you want to be on the safe side when growing a beautiful flower, you’d also rather plant seedlings instead of casting seeds.“
Following the lean production principle, the Austrian start-up Single Use Support has developed an integrable, holistic platform to cover the entire seed train intensification process for any given amount, all the way from protecting cultivated drug substances in single-use bags to fully automated filling and freezing, refrigerated transport, thawing and emptying of the bags at their final destination.
Such an agile approach is much easier to accomplish by utilizing platforms that are flexible by nature. SEED.STREAM is a closed, yet highly flexible, system that guarantees sterility by eliminating manual handling as far as possible. At the same time, it accelerates the speed of production and simplifies not only the entire operation but also the adaptation to different requirements and volumes as needed.
Like all of Single Use Support’s technologies, SEED.STREAM consists a variety of disposable parts that can be scaled in both directions.
In terms of scalability, the process can be fitted with a larger or smaller number of modules – just like a train – to achieve the required volume of cells, which adds to the list of benefits that comes with employing single-use technology:
“It considerably lowers the risk of contamination and product loss if you obtain all technologies from a single source. Complete solutions play a vital role in increasing patient safety by minimizing the risk of bio-contamination,” says Johannes Kirchmair, co-founder of Single Use Support.
If you want to be on the safe side when growing your cell cultures, be it for clinical studies or in bigger volumes for blockbuster production, SEED.STREAM is the way forward.