Ottiger H P
Institute of Virology and Immunoprophylaxis IVI, OMCL Vaccine Control, Swiss Federal Veterinary Office, Mittelhäusern, Switzerland.
Dev Biol (Basel). 2006;126:309-19; discussion 327.
The detection of extraneous agents (EA) has always been critical for assessing the safety associated with vaccines. Vaccines and other biological medicines are derived from living substrates. This poses particular problems with regard to assuring their efficacy and safety due to the inherent variability of starting materials, the production processes, and the complex nature of the products themselves. For viral vaccines and other biological medicines, the key to effective quality control is rigorous testing and validation applied to the seed lots and also to the final batches. The quality assurance requirements for marketing products in Europe are given in the European Pharmacopoeia (EP). With the advent of molecular biotechnology, there are increasing uses of molecular methods for the characterization and quality control of vaccines. PCR for extraneous agent testing for live and inactivated poultry vaccines has been recognized to be a valid alternative testing method and is now being used extensively as a diagnostic tool in assuring the freedom from EAs. A number of generic PCR assays for product testing have been developed and validated. The current status and issues of the application of nucleic acid testing (NAT) to the standardization and control of vaccines will be reviewed.
检测外源因子（EA）对于评估疫苗的安全性一直至关重要。疫苗和其他生物药品源自活体基质。由于起始原料、生产工艺的固有变异性以及产品本身的复杂性质，这在确保其有效性和安全性方面带来了特殊问题。对于病毒疫苗和其他生物药品，有效的质量控制关键在于对种子批以及最终批次进行严格测试和验证。欧洲药典（EP）给出了欧洲上市产品的质量保证要求。随着分子生物技术的出现，分子方法在疫苗的特性鉴定和质量控制中的应用越来越多。用于活禽和灭活禽用疫苗外源因子检测的PCR已被公认为一种有效的替代检测方法，目前作为确保无EA的诊断工具被广泛使用。已经开发并验证了许多用于产品检测的通用PCR检测方法。将综述核酸检测（NAT）在疫苗标准化和控制中的应用现状及问题。
