Pasik Katarzyna, Domańska-Blicharz Katarzyna, Iwan Ewelina, Bomba Arkadiusz
Department of Veterinary Pharmacy, Puławy, Poland.
Department of Poultry Diseases, Puławy, Poland.
J Vet Res. 2024 Dec 21;68(4):475-485. doi: 10.2478/jvetres-2024-0069. eCollection 2024 Dec.
In Europe, veterinary vaccines are strictly controlled by the Official Medicines Control Laboratories (OMCLs) of the General European OMCL Network, coordinated by the European Directorate for the Quality of Medicines & HealthCare. Despite a meticulous verification programme for immunological veterinary medicinal products (IVMPs), the products' genomic composition has not yet been subject to evaluation in veterinary pharmacy.
A study was carried out on Poland's poultry vaccines containing the infectious bronchitis virus which have the greatest market penetration. Three batches of three different vaccines were high-throughput sequenced and analysed for genomic composition, frequency of variants and the phylogeny of the strains.
The main genetic component of each vaccine was infectious bronchitis coronavirus. The identity of the vaccine strain types was confirmed to be consistent with the manufacturer's declaration (793B, Mass and QX). Most variants were identified for the same nucleotide positions in all three batches of each vaccine, demonstrating the homogeneity of the samples, while unique variants specific to single batches were rare.
High-throughput sequencing (HTS) is an effective alternative poultry IVMP quality control tool for OMCLs. This technique allows in-depth characterisation of a vaccine strain and assessment of its conformance to the manufacturer's declaration. Importantly, HTS brings new cognitive value to IVMP quality control, because it makes monitoring the level of revertants possible. However, before it could be introduced into routine quality control, a thorough analysis and characteristics of the IVMP to be evaluated is needed from the medical product's manufacturer.
在欧洲，兽用疫苗受到欧洲药品与医疗保健质量局协调的欧洲官方药品控制实验室网络（OMCLs）的严格管控。尽管对兽用免疫药品（IVMPs）有细致的验证程序，但这些产品的基因组组成在兽医药学中尚未得到评估。
对波兰市场渗透率最高的含传染性支气管炎病毒的家禽疫苗进行了一项研究。对三批三种不同的疫苗进行了高通量测序，并分析了其基因组组成、变异频率和毒株的系统发育。
每种疫苗主要的遗传成分是传染性支气管炎冠状病毒。疫苗毒株类型的一致性经确认与制造商的声明（793B、Mass和QX）相符。在每种疫苗的所有三批产品中，大多数变异都出现在相同的核苷酸位置，表明样本具有同质性，而单批产品特有的独特变异很少见。
高通量测序（HTS）是OMCLs用于家禽IVMP质量控制的一种有效替代工具。该技术能够深入表征疫苗毒株并评估其与制造商声明的一致性。重要的是，HTS为IVMP质量控制带来了新的认知价值，因为它使监测回复株水平成为可能。然而，在将其引入常规质量控制之前，需要医疗产品制造商对要评估的IVMP进行全面分析和特性鉴定。
