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Establishment of the first international standard for PEGylated granulocyte colony stimulating factor (PEG-G-CSF): Report of an international collaborative study

机译：建立第一个国际标准的聚乙二醇化粒细胞集落刺激因子（PEG-G-CSF）：一项国际合作研究的报告

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We assessed the feasibility of developing a suitable international reference standard for determination of in vitro biological activity of human sequence recombinant PEG-G-CSF products with a 20 kD linear PEG linked to the N-terminal methionyl residue of G-CSF (INN Filgrastim), produced using a conjugation process and coupling chemistry similar to that employed for the lead PEGfilgrastim product. Based on initial data which showed that the current WHO 2nd international standard, IS for G-CSF (09/136) or alternatively, a PEG-G-CSF standard with a unitage traceable to the G-CSF IS may potentially serve as the IS for PEG-G-CSF products, two candidate preparations of PEG-G-CSF were formulated and lyophilized at NIBSC. These preparations were tested by 23 laboratories using in vitro bioassays in a multi-centre collaborative study. Results indicated that on the basis of parallelism, the current WHO 2nd IS for G-CSF or any of the PEG-G-CSF samples could be used as the international standard for PEG-G-CSF preparations. However, because of the variability in potency estimates seen when PEG-G-CSF preparations were compared with the current WHO 2nd IS for G-CSF, a candidate PEG-G-CSF was suitable as the WHO IS. The preparation 12/188 was judged suitable to serve as the WHO IS based on in vitro biological activity data. Therefore, the preparation coded 12/188 was established by the WHO Expert Committee on Biological Standardization (ECBS) in 2013 as the WHO 1st IS for human PEGylated G-CSF with an assigned in vitro bioactivity of 10,000 IU per ampoule.
机译：我们评估了开发合适的国际参考标准以测定人序列重组PEG-G-CSF产品的体外生物学活性的可行性，该产品具有与G-CSF N末端甲硫酰基残基相连的20 kD线性PEG（INN Filgrastim） ，使用类似于PEGfilgrastim铅产品的偶联方法和偶联化学方法生产。根据初步数据，该数据表明当前的WHO第二国际标准，即G-CSF IS的IS（09/136），或者具有可追溯至G-CSF IS的单位的PEG-G-CSF标准，有可能成为IS对于PEG-G-CSF产品，配制了两种PEG-G-CSF候选制剂并在NIBSC冻干。这些制剂由23个实验室使用多中心协作研究中的体外生物测定法进行了测试。结果表明，在平行度的基础上，当前用于G-CSF或任何PEG-G-CSF样品的WHO 2nd IS可以用作PEG-G-CSF制剂的国际标准。但是，由于将PEG-G-CSF制剂与当前的WHO第二代IS用于G-CSF的效价估计值存在差异，因此候选PEG-G-CSF适合作为WHO IS。根据体外生物活性数据，认为制剂12/188适合用作WHO IS。因此，由WHO生物学标准化专家委员会（ECBS）在2013年建立了编码为12/188的制剂，作为WHO对人PEG化G-CSF的1st IS，其体外生物活性为10,000 IU /安瓿。

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