Human lymphoblastoid interferon for clinical trials: large scale purification and safety tests

Human lymphoblastoid cell lines are one of the best sources for the production of large amounts of human interferon for clinical trials. The potential risk of using transformed cell lines for production of a substance for human use can be overcome by an extensive purification of the interferon to a high degree, and by carefully testing the final product for DNA content and toxic materials. In previous reports we described a method for large scale production of interferon by a human lymphoblastoid cell line (Namalva). In this report a system for large scale purification of Namalva interferon and safety tests is presented. The procedure consists of three main steps: 1. Concentration of crude interferon by ultrafiltration. II. Gel filtration on Sephadex G-75 or Ultrogel AcA 54 columns. III. Affinity chromatography on anti-interferon antibody column. All steps were adapted for the processing of batches of hundreds of litres and can be easily further scaled-up. The final highly purified product undergoes a series of quality control tests such as purity, sterility, toxicity, pyrogenicity and DNA content. After passing all tests the IFN is released for clinical trials.