施贵宝（Bristol-Myers Squibb）发言人近日表示，经评估，与Cellares合作的细胞穿梭系统被认定无法满足生产商业化Breyanzi所需的严格要求。这一决定意味着该合作伙伴关系下的技术平台，在关键性能指标上未能达标，无法支撑CAR-T疗法的大规模制造。发言人补充道，公司对质量与合规性始终秉持最高标准，任何环节的偏差都可能导致最终产品不符合监管与临床预期。因此，施贵宝选择终止该项合作评估，转而寻求其他可行的生产路径，以确保Breyanzi的供应稳定性和患者可及性不受影响。尽管Cellares的系统在早期测试中展现出一定潜力，但面对商业规模生产的复杂性与严苛条件，其表现仍存在显著差距。这一决策反映出细胞治疗领域在工艺放大与质量控制方面所面临的普遍挑战，同时也凸显了创新技术在从实验室走向市场过程中必须跨越的鸿沟。施贵宝方面未透露更多技术细节，但强调将继续致力于优化生产流程，并探索多元化的合作机会，以推动其肿瘤学管线的高效落地。
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