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Comparability studies of hemin from two different origins porcine and bovine in the production of Haemophilus influenzae type b (Hib) polysaccharide.
Biologicals ( IF 1.7 ) Pub Date : 2020-08-04 , DOI: 10.1016/j.biologicals.2020.07.006
Suresh Beri 1 , Darshan Gandhi 1 , Pankaj Sharma 1 , Dattatraya Gundpatil 1 , Sunil Goel 1 , Sunil Gairola 1
Affiliation  

Hemin is one of the critical components of medium required for growth of Haemophilus influenzae type b (Hib) organisms. It is important to have different sources of critical components to ensure continuous supply for commercial production. Regulatory bodies also recommend having multiple sources for critical components. Hemin is produced from animal blood and the main sources are porcine and bovine origin. The approved Hib vaccine of SIIPL used for immunization is produced using hemin obtained from porcine origin. The present work focuses on the comparison of the growth of organisms on a large scale using hemin from bovine or porcine origin. Purified polysaccharide obtained using bovine source is tested with respect to the set WHO specifications as recommended by regulatory bodies and compared with commercial lots of PRP obtained from using hemin of porcine source. Identical product profile and quality attributes were obtained for PRP produced using bovine hemin and the regular commercial product suggests that there is no change in the product. Hemin from bovine source can be used as a replacement for hemin from porcine source in the fermentation medium for country specific requirement of Hib conjugate vaccine as long as it meets the guidelines on TSE/BSE risk.



中文翻译:

两种不同来源猪和牛血红素在生产 b 型流感嗜血杆菌 (Hib) 多糖中的可比性研究。

血红素是流感嗜血杆菌生长所需培养基的关键成分之一b型(Hib)生物。重要的是要有不同的关键组件来源,以确保商业生产的持续供应。监管机构还建议为关键组件提供多个来源。血红素是从动物血液中提取的,主要来源是猪和牛。用于免疫的经批准的 SIIPL Hib 疫苗是使用从猪来源获得的血红素生产的。目前的工作侧重于使用牛或猪来源的血红素大规模比较生物体的生长。使用牛源获得的纯化多糖按照监管机构推荐的 WHO 规范进行测试,并与使用猪源血红素获得的商业批次 PRP 进行比较。使用牛血红素生产的 PRP 获得了相同的产品概况和质量属性,常规商业产品表明产品没有变化。只要符合 TSE/BSE 风险指南,牛源血红素可用作发酵培养基中猪源血红素的替代品,以满足国家对 Hib 结合疫苗的特定要求。

更新日期:2020-10-06
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