FDA OK for Life Therapeutics' tetanus serum
Tuesday, 15 February, 2005
Life Therapeutics' (formerly Gradipore, ASX: LFE) US subsidiary Life Sera has received FDA approval to begin collecting tetanus hyperimmune serum for use as a prophylactic treatment following potential exposure to the tetanus toxin.
The product may bring US$2 million of sales into the company this calendar year. It is the third new product to be produced by Life Sera in the last three years and the second licensed product since the business was acquired by Life Therapeutics a year ago.
Last week, Life Therapeutics said its Life Bioprocess division in Sydney had completed the evaluation of its Gradiflow technology for the purification of high quality transgenic IgG for US-based company Hematech.
The technology was shown to be scalable and also to efficacious at removing both viral and DNA contaminants during the separation process, meeting regulatory requirements for biological manufacturing processes.
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