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Veterinary vaccine development from an industrial perspective.

机译:从工业角度看兽用疫苗的开发。

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摘要

Veterinary vaccines currently available in Europe and in other parts of the world are developed by the veterinary pharmaceutical industry. The development of a vaccine for veterinary use is an economic endeavour that takes many years. There are many obstacles along the path to the successful development and launch of a vaccine. The industrial development of a vaccine for veterinary use usually starts after the proof of concept that is based on robust academic research. A vaccine can only be made available to the veterinary community once marketing authorisation has been granted by the veterinary authorities. This review gives a brief description of the regulatory requirements which have to be fulfilled before a vaccine can be admitted to the market. Vaccines have to be produced in a quality controlled environment to guarantee delivery of a product of consistent quality with well defined animal and consumer safety and efficacy characteristics. The regulatory and manufacturing legislative framework in which the development takes place is described, as well as the trend in developments in production systems. Recent developments in bacterial, viral and parasite vaccine research and development are also addressed and the development of novel adjuvants that use the expanding knowledge of immunology and disease pathology are described.
机译:目前在欧洲和世界其他地区可获得的兽用疫苗是由兽药工业开发的。兽用疫苗的开发是一项需要多年的经济努力。成功开发和推出疫苗的过程中存在许多障碍。兽医用疫苗的工业开发通常在基于可靠的学术研究的概念证明之后开始。只有获得兽医部门的销售许可后,才能向兽医社区提供疫苗。这篇综述简要介绍了疫苗进入市场之前必须满足的监管要求。疫苗必须在质量控制的环境中生产,以确保交付具有明确定义的动物和消费者安全性和功效特性的稳定质量的产品。描述了进行开发的法规和制造法律框架,以及生产系统的发展趋势。还讨论了细菌,病毒和寄生虫疫苗研究和开发的最新进展,并描述了利用免疫学和疾病病理学不断发展的知识的新型佐剂的开发。

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