Evaluation of recombinant human interferon beta 1b by liquid chromatography methods and bioassay

Recombinant human interferon beta 1b (rhIFNß-1b) is clinically used to treat multiple sclerosis. A reversed-phase liquid chromatography (RP-LC) method was carried out on a Jupiter C4 column (250 mm × 4.6 mm i.d.). The mobile phase A consisted of 0.1% trifluoroacetic acid (TFA) in water, and the mobile phase B was acetonitrile with 0.1% TFA run at a flow rate of 1.0 mL/min. A size exclusion liquid chromatography (SE-LC) method was carried out on a BioSep-SEC-S 2000 column (300 mm × 7.8 mm i.d.). The mobile phase consisted of 1 mM monobasic potassium phosphate, 8 mM sodium phosphate dibasic and 200 mM sodium chloride buffer pH 7.4, run isocratically at a flow rate of 0.8 mL/min. Retention times were 31.87 and 17.78 min, and calibration curves were linear over the concentration range of 1-200 µg/mL (r2 = 0.9998) and 0.50-200 µg/mL (r2 = 0.9999), respectively, for RP-LC and SE-LC, with detection at 214 nm. Liquid chromatography (LC) methods were validated and employed in conjunction with the in vitro bioassay to assess the content/potency of rhIFNß-1b, contributing to improve the quality control and to ensure the efficacy of the biotherapeutic

The Global Development of the Biopharmaceutical Industry / 中国生物工程杂志

The number of new medical products based on chemistry launches at the lowest level for many years. The pharmaceutical industry puts emphasis on biotechnology-derived products. Both genomics and protemics are contributing to understanding and determining more targets which involved in human disease.This means that there will be more opportunities for biopharmaceutical breakthroughs,eventually,more and better biomedicines will be approved.Several trends in development for biopharmaceuticals were analyzed:(1) Biological medicine and Chinese traditional medicine have developed rapidly between 1998~2005, the number of the papers about biological medicine increases dramaticly. (2)The emphasis is on biological medicine in pharmaceutical industry and the biotech market is concentrating in United States and multinational. (3)The proportion of biotech products is becoming larger gradually. More concern is focused on biotech products.(4)In order to reduce the cost of R&D and increase the number of new drugs, more and more M&A occur between the biotech companies.(5)The governments all over the world attach importance to biotech products.(6)Tissue engineering, cell therapy and gene therapy have a good future, full of opportunities and challenges.