Gross S
Paul-Ehrlich-Institut, Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel, Paul-Ehrlich-Straße 51-59, 63225, Langen, Deutschland,
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2014 Oct;57(10):1185-7. doi: 10.1007/s00103-014-2034-0.
The Paul-Ehrlich Institute (PEI) is an independent institution of the Federal Republic of Germany responsible for performing official experimental batch testing of sera. The institute decides about the release of each batch and performs experimental research in the field. The experimental quality control ensures the potency of the product and also the absence of harmful impurities. For release of an immunoglobulin batch the marketing authorization holder has to submit the documentation of the manufacture and the results of quality control measures together with samples of the batch to the PEI. Experimental testing is performed according to the approved specifications regarding the efficacy and safety. Since implementation of the 15th German drug law amendment, the source of antibody is not defined anymore. According to § 32 German drug law, all batches of sera need to be released by an official control laboratory. Sera are medicinal products, which contain antibodies, antibody fragments or fusion proteins with a functional antibody portion. Therefore, all batches of monoclonal antibodies and derivatives must also be released by the PEI and the marketing authorization holder has to submit a batch release application. Under certain circumstances a waiver for certain products can be issued with regard to batch release. The conditions for such a waiver apply to the majority of monoclonal antibodies.
保罗·埃利希研究所（PEI）是德意志联邦共和国的一个独立机构，负责对血清进行官方实验性批次检测。该研究所决定每一批次的放行，并在该领域开展实验研究。实验质量控制确保了产品的效力以及不存在有害杂质。对于免疫球蛋白批次的放行，上市许可持有人必须向PEI提交生产文件、质量控制措施结果以及该批次的样品。实验检测是根据关于效力和安全性的批准规范进行的。自德国第15次药品法修正案实施以来，抗体来源不再有明确规定。根据德国药品法第32条，所有血清批次都需要由官方控制实验室放行。血清是含有抗体、抗体片段或具有功能性抗体部分的融合蛋白的药品。因此，所有单克隆抗体及其衍生物批次也必须由PEI放行，上市许可持有人必须提交批次放行申请。在某些情况下，可以针对特定产品发布批次放行豁免。此类豁免的条件适用于大多数单克隆抗体。
