Habisch Rebecca, Neubauer Peter, Soza-Ried Jorge, Puschmann Eva
Boehringer Ingelheim, Viral Therapeutics Center, Ochsenhausen, Germany.
Department of Bioprocess Engineering, Institute of Biotechnology, Technische Universität Berlin, Berlin, Germany.
Front Bioeng Biotechnol. 2024 Dec 5;12:1505338. doi: 10.3389/fbioe.2024.1505338. eCollection 2024.
Viral products keep gaining importance in multiple therapeutic fields. Considering the scale and production slot limitations, optimizing the outcome of every manufacturing batch is essential to minimize costs and make this therapeutic modality broadly available to patients. Most manufacturing processes for oncolytic viruses currently in clinical studies are based on a batch process. Here, we evaluated the benefits in terms of titer increase of a repeated harvest approach and compared it to the classical batch production process. While no effect on cell density was observed, the cumulated infectious titer following repeated harvest was over 400 times higher than the evaluated batch process yield. This shows that repeated harvests or perfusion have the potential to boost viral yields and should be considered when deciding on a process format for production.
病毒产品在多个治疗领域的重要性不断增加。考虑到规模和生产时段限制,优化每个生产批次的结果对于降低成本以及使这种治疗方式能够广泛应用于患者至关重要。目前临床研究中的大多数溶瘤病毒制造工艺都基于分批工艺。在此,我们评估了重复收获方法在提高滴度方面的益处,并将其与传统的分批生产工艺进行了比较。虽然未观察到对细胞密度的影响,但重复收获后的累积感染滴度比评估的分批工艺产量高出400多倍。这表明重复收获或灌注有可能提高病毒产量,在决定生产工艺形式时应予以考虑。