Product case study Avastin

Avastin (tradename, also known as bevacizumab) is a 149 kDa recombinant humanized monoclonal IgG1 antibody first approved for medical use in the USA in 2004, and subsequently in the EU in 2005. It is indicated for first-line treatment of patients with metastatic colorectal cancer, in combination with specified (5-fluorouricil-based) small molecule chemotherapeutic drugs.

The antibody brings about its effect by inhibiting angiogenesis (the formation of new blood vessels), a process required to support tumour growth. Specifically, the antibody binds human vascular endothelial growth factor. This prevents the latter from binding to its cell surface receptor, a process central to triggering new blood vessel formation in both normal and diseased tissue.

The engineered antibody is produced in a CHO cell line using 12 000 l bioreactors. Purification is achieved mainly by protein A affinity chromatography, followed by sequential anion and cation ion-exchange chromatography. It is formulated as a sterile solution in single-use vials containing either 100 or 400 mg active substance. Excipients include phosphate buffer components, trehalose and polysorbate 20. The product is generally administered by i.v. infusion (5 mg kg-1) once every 2 weeks.

Pharmacokinetic studies in patients yielded an estimated product half-life of approximately 20 days (11-50 days range) and the product clearance was found to be variable according to body weight, gender and tumour burden. Safety and efficacy were established by three randomized, controlled trials. The first study was a randomized double-blind trial involving 813 patients. The primary end-point measured was overall survival, which was extended from a median of 15.6 months to 20.3 months.

Serious, sometimes fatal, side effects reported included gastrointestinal perforation, wound healing complications and haemorrhage, and the product should not be administered for at least 28 days following major surgery. Avastin was developed by Genentech.

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