本次会议涉及生物制药的病毒清除研究的合理设计，包括重组蛋白，如单克隆抗体和，作为研讨会的新范围，腺相关病毒（AAV）载体的病毒清除。对于重组蛋白，在过去的几十年中积累了大量数据集，旨在用于加速产品工艺开发和简化病毒清除研究。如何在病毒清除验证中利用先验知识，以及如何在风险评估工具中使用它来决定在产品开发期间是否需要进行额外的病毒清除研究，本次会议的三个介绍都在讨论。这还包括用于新型洗涤剂(例如CG-110)的先验预期设计和验证数据的生成,以建立平台数据集,用作未来营销应用中的先验知识。另一个介绍研究了新开发的疏水相互作用色谱（HIC）树脂的病毒去除机制，并证明了与最近的HIC树脂的中度至较差的病毒减少相比，在定义的过程范围内，高度疏水抗体对逆转录病毒和杂质的适当减少。最后两个演讲涉及AAV的病毒清除方法，随着ICHQ5A修订版的批准，这将成为强制性的。适当的病毒去除和病毒灭活程序可以实施到AAV载体的制造过程中，包括病毒过滤，病毒灭活(例如，热失活)，亲和层析,和阴离子交换色谱法，似乎可以对辅助病毒和外来病毒实现良好的清除。当理解产物特征和工艺条件时,热处理步骤甚至可以是AAV产物的腺病毒辅助灭活的稳健步骤。
This session deals with the rational design of viral clearance studies for biopharmaceuticals including recombinant proteins such as monoclonal antibodies and, as new in scope of the symposium, also viral clearance for adeno-associated viral (AAV) vectors. For recombinant proteins, large datasets were accumulated over the last decades and are intended to be used for accelerated product process development and streamlining of viral clearance studies. How to utilize prior knowledge in viral clearance validation and how it can be used in a risk assessment tool to decide whether additional virus clearance studies are necessary during product development is being addressed by three of the presentations of this session. This also includes an a priori intended design and generation of validation data for a new kind of detergent such as CG-110, to build up a platform dataset to be used as prior knowledge in future marketing application. Another presentation investigates the virus removal mechanism of a newly developed hydrophobic interaction chromatography (HIC) resin and demonstrates for highly hydrophobic antibodies appropriate reduction for a retrovirus and impurities in a defined process range in contrast to the moderate to poor virus reduction of recent HIC resins. The last two presentations deal with virus clearance approaches for AAV, which will become mandatory with approval of the ICH Q5A revision. Appropriate virus removal and virus inactivation procedures can be implemented into the manufacturing processes of AAV vectors including viral filtration, viral inactivation (e.g., heat inactivation), affinity chromatography, and anion-exchange chromatography with which it seems possible to achieve a good clearance for helper and also adventitious viruses. The heat treatment step can be even a robust step for adenovirus helper inactivation for AAV products when product characteristics and process conditions are understood.
