Establishment of Pertussis toxin BRP batch 2 for CHO clustering assay.

Q4 Medicine Pharmeuropa bio & scientific notes Pub Date : 2021-01-01
M Wall, A Costanzo, D Le Tallec, R Isbrucker
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Abstract

Recently, the Chinese hamster ovary (CHO) cell-based clustering assay replaced the in vivo Histamine Sensitisation Test (HIST) in mice in European Pharmacopoeia (Ph. Eur.) general chapter 2.6.33. ‘Residual pertussis toxin’ as the recommended method to test for residual pertussis toxin in acellular pertussis vaccine intermediates. To support the standardised CHO clustering assay, availability of a reference standard is critical. Ph. Eur. pertussis toxin Biological Reference Preparation (BRP) batch 1 was first calibrated in International Units in 2008 for the HIST and subsequently also calibrated for the CHO clustering assay in 2017. However, its stocks were dwindling and needed to be replaced. In an effort to maintain adequate supply, a project (BSP141) was initiated by the European Directorate for the Quality of Medicines & HealthCare (EDQM), under the aegis of the Biological Standardisation Programme, to establish a second pertussis toxin BRP (BRP2). Candidate material was manufactured ad hoc by an acellular pertussis vaccine manufacturer and an optimal formulation for long-term stability was defined. Exhaustive in-process and post-production controls demonstrated that the material was fit for its intended purpose and therefore a collaborative study for calibration and stability assessment of the candidate material was organised, which included 10 laboratories worldwide. As a result of the study, the candidate material was established as Ph. Eur. Pertussis toxin BRP batch 2 with a potency of 130 IU/vial for the CHO clustering assay. Unopened vials must be stored at −20°C. The BRP may be used for up to two weeks after reconstitution if appropriately handled and stored at 2–8°C.

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百日咳毒素BRP 2批CHO聚类试验的建立。
最近,在欧洲药典(Ph. Eur.)通则2.6.33章中,以中国仓鼠卵巢(CHO)细胞为基础的聚类试验取代了小鼠体内组胺致敏试验(HIST)。“残留百日咳毒素”是检测无细胞百日咳疫苗中间体中残留百日咳毒素的推荐方法。为了支持标准化的CHO聚类分析,参考标准的可用性至关重要。博士欧元。百日咳毒素生物参比制剂(BRP)第1批于2008年首次在国际单位中进行了HIST校准,随后于2017年进行了CHO聚类分析校准。然而,它的库存正在减少,需要更换。为了保持充足的供应,欧洲药品和保健质量理事会(EDQM)在生物标准化计划的支持下启动了一个项目(BSP141),以建立第二种百日咳毒素BRP (BRP2)。候选材料由非细胞百日咳疫苗制造商临时制造,并确定了长期稳定性的最佳配方。详尽的过程和生产后控制证明该材料符合其预期用途,因此组织了一项候选材料的校准和稳定性评估合作研究,其中包括全球10个实验室。研究结果表明,候选材料被确定为Ph. Eur。百日咳毒素BRP第2批效力为130 IU/瓶CHO聚类分析。未开封的小瓶必须在- 20°C下保存。如果处理得当并保存在2-8°C, BRP可在重组后使用长达两周。
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Pharmeuropa bio & scientific notes
Pharmeuropa bio & scientific notes Medicine-Medicine (all)
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