Manufacture and Composition

Upstream processing (cell culture) is generally performed in three sequential stages; a lab-scale seed train, an inoculum train, and a production culture. The production-scale culture is normally undertaken in a 12,000 L fermenter. The product is exported by the CHO cells into the extracellular media. Downstream processing is initiated by removal of cells from the production media, followed by a combination of high-resolution chromato-graphic steps as well as a viral inactivation step and a number of filtration steps. After excipient adjustment and adjustment of potency, the product is filter sterilized, aseptically filled into glass vials, and lyophilized. The final product contains the active substance Tenecteplase as well as L-Arg, phosphoric acid, and polysorbate 80 as excipients. The product is reconstituted immediately before use in WFI, which is provided in a prefilled syringe for single bolus IV administration [40].

Was this article helpful?

0 0

Post a comment