Hib疫苗生产和制造工艺_英文版录入.docVIP

Haemophilus influenzae Type b Conjugate Vaccine Haemophilus influenzae Type b Conjugate Vaccine is a preparation made by covalently binding the purified capsular polysaccharide (CPS) antigen from Haemophilus influenzae Type b to tetanus toxoid through the linkage of adipic dihydrazide (ADH). It is used to prevent childhood infectious diseases caused by Haemophilus influenzae Type b, such as cerebrospinal meningitis, and pneumonia, etc. Basic requirement The facilities, source and subsidiary materials, water, apparatus, and animals used for production and quality control shall comply with the requirements set forth in the General Notices. Manufacturing Bacterial seed The bacterial seed used for production complies with the Requirements for Bacterial and Viral strains/seeds Used for Production and Quality Control of Biologics. Name and origin of bacterial strains The bacterial strain used for production shall be Haemophilus influenzae type b strain CMCC58547 or CMCC58534. Establishment of seed lot system It complies with the Requirements for Bacterial and Viral strains/seeds Used for Production and Quality Control of Biologics. Passage of seed lots The subculture of the seed from master seed lot to working seed lot shall not exceed five passages; the subculture of the seed from working seed lot to the final fermentation shall not exceed five passages. Control tests on the seed lots Chocolate agar medium containing sheep blood or Hib comprehensive medium can be used for the control tests on the seed lots. Cultural characteristics The Hib strain shall not grow on a common agar medium, but grow on a chocolate agar medium containing sheep blood or a Hib comprehensive medium. Its growth requires Factor X ( chlorhematin ) and Factor V ( β coenzyme A ); the satellite phenomenon shall be positive; the colonies shall be greyish-white, translucent, smooth, convex and humid with regular edge. Microscopic examination of stained smears The stained smears made from the culture sh