Upstream & Downstream Manufacturing Process

In the pharmaceutical industry upstream and downstream are the two major steps in bioprocess manufacturing of small molecules and biologics, e.g. ribo-mAbs, hormones, cell and gene therapies.

Upstream processing includes media preparation, inoculum, fermentation and or cell expansion/division and harvest. Goal is to produce cells or cell-derived molecules from defined/optimized strains/cell lines with most possible yield.

Downstream, on the other hand, includes unit operations for isolating, purification, concentration and formulation to obtain the final biopharmaceutical product at highest quality, efficacy and stability. Chromatography, filtration and separation are utilized in process steps to support inactivation of viruses, removal of impurities, particles and buffer exchange and concentration.

Single use bag filling system RoSS.FILL

Fluid Management around Single-Use Technologies

E2E Process Overview_QUER_with Manifold

Closely connected to the implementation of both production processes upstream and downstream is the contribution of single-use technologies in biophharma. Single-use systems are likely to be relied on for media preparation, connecting the process flow with starting materials and intermediate steps but also the cold chain transport. A wide range of products supporting and involving single-use systems come into play:

Products

Single-use bioprocess container by Single Use Support

Packaging: IRIS Single-Use Bioprocess Container

Innovative. Robust. Individual. Single-Use. Make sure your supply chain is uninterrupted. Get your IRIS single-use bioprocess container from Single Use Support in any size with the fastest possible delivery times. Store and ship anything from cell culture samples to large drug substance volumes reliably and on time.

RoSS.FILL - single use filling system for drug substances

Fill & Drain: RoSS.FILL

RoSS.FILL is a flexible automated single-use technology for dispensing biopharmaceuticals into single-use bags. The fluid path is designed to be fully disposable and is able to accommodate a variety of sterile connection and disconnection options.

ross-pftu-large-scale

Freeze & Thaw: RoSS.pFTU Large-Scale

Our large scale freezing platform system is a plate-based freeze-thaw unit for any scale and batch size. Well-established RoSS.pFTU large scale is compatible with single-use bags of all sizes and manufacturers. The hybrid solution offers freeze-thaw capabilities for bags and bottles up to 220L in one platform.