On Sept. 13, 2001, the Food and Drug Administration (FDA) announced it had approved Genentech’s  request for it’s biologics license application for Alteplase, to provide for a 2 mg vial strength and a new indication for the restoration of function to central venous access devices (as assessed by the ability to withdraw blood). The labeling had the trade name Cathflo Activase.

Cathflo
Activase
[Alteplase] is a tissue plasminogen activator (t-PA) produced by recombinant DNA technology. It is a sterile, purified glycoprotein of 527 amino acids. It is synthesized using the complementary DNA (cDNA) for natural human tissue-type plasminogen activator (t-PA) obtained from an established human cell line.

The manufacturing process involves secretion of the enzyme Alteplase into the culture medium by an established mammalian cell line (Chinese hamster ovary cells) into which the cDNA for Alteplase has been genetically inserted. Fermentation is carried out in a nutrient medium containing the antibiotic gentamicin sulfate, 100 mg/L. The presence of the antibiotic is not detectable in the final product.