SEED.STREAM

NEXT Generation Cell Culture Intensification: Taking the shortcut in biopharma upstream manufacturing process!

SEED.STREAM by Single Use Support describes the next generation of cell culture intensification - 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 technologies by Single Use Support. This process includes end-to-end qualification during filling, freezing, thawing and draining of drug substance.

At the very early stage of biopharma drug substance manufacturing, the cell banking during upstream, cells are being nurtured from 1 ml to more than 2000 liters within approx. 5 weeks. There are many potential pitfalls in terms of sterility and appropriate cell perfusion when it comes to growing cell lines to their full potential.
Seed train intensification is a way to circumvent the continuous “back to start” with 1 ml and to benefit from the already expanded cells into bioreactors.

 

More than 60% time savings -> start at 5 instead of at 0, every time.
Reduce contamination potential -> close your cell seeding into cryobags.
Be room independent -> distribute seed train intermediates to decentralized global production facilities.

 

And this is where the SEED.STREAM, the next generation of seed train intensification, comes into play.

The very fragile cells need advanced automation, process control and high cell density cryopreservation in order to

  • secure sterility by process in a closed system
  • avoid manual handling
  • reduce environmental requirements at the manufacturing site
  • accelerate the speed of production
  • simplify the operation in-plant and
  • save huge operation costs during repetitive upstream

If you want to be on the safe side when growing a beautiful flower, you’d also rather plant seedlings instead of casting seeds.

MANUFACTURER CELL BANK
SEED TRAIN

Seed train intensification for upstream process - SEED.STREAM the next generation

The term seed train intensification describes the upstream process of cell culture intensification in order to generate an adequate number of cells for the inoculation of a production bioreactor. This procedure takes place during the upstream process at the very beginning of biopharma drug substance manufacturing. Within approx. 5 weeks, cells are being nurtured from 1 ml to the required amount, which can reach more than 2,000 liters.

Lean production principles applied to seed train intensification for upstream process

Cells are a highly fragile matter that requires automated and controlled handling during the entire seed train intensification for upstream process in order to guarantee optimum results. SEED.STREAM by Single Use Support is based on lean production principles and utilizes single-use components to generate a closed process with the advantages of

  • avoiding manual handling
  • securing sterility
  • accelerating production speed
  • increasing output
  • simplifying in-plant operation
  • reducing costs and environmental requirements

Flexible and scalable seed train intensification on the basis of single-use technologies

Additionally, thanks to the flexible nature of single-use technology components, if you employ SEED.STREAM for your seed train intensification, you can cultivate any given volume of cells.

SEED.STREAM process by Single Use Support is scalable in both directions – it allows you to cater to your exact needs– no more and no less. As opposed to traditional methods that are based on large stainless-steel Cryovessels, this advanced system utilizes multiple single-use bags for the process of cell culture intensification. With volumes ranging from 10 ml to 20 l each, this approach allows for the highest possible level of flexibility and scalability and can be used all the way from the lab to blockbuster production.

A holistic and comprehensive platform for the entire seed train intensification for upstream processes

SEED.STREAM is an integrable, holistic platform that covers the entire seed train intensification for upstream processes all the way from protected cultivation in single-use bags to fully automated filling and freezing, refrigerated transport, thawing and emptying of the bags at their final destination. It is a closed, yet highly flexible, system that guarantees sterility by eliminating manual handling as far as possible.

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.