Recombinant Thrombolytic Agents

Recombinant tissue plasminogen activator (tPA) was the first product from cell culture (7). Genentech obtained the approval for tPA production from CHO cells in 1987 (Table 2). tPA is produced in a large-scale (>10,000 L) cell culture process. Although the current tPA is highly efficacious, there are several attempts to improve the pharmacokinetics of the molecule. In addition, there is a new generation of recombinant thrombolytic agents under development.

Recombinant tPA from Genentech is marketed as Activase® and it is used for acute myocardial infarction (approved in 1987), acute massive pulmonary embolism (approved in 1990), acute myocardial infarction accelerated infusion (approved in 1995), and ischemic stroke within 3-5 hr of symptom onset (approved in 1996).

Table 1 Approved Monoclonal Antibodies

Product

Company

Indication

Approved

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