全球生物制药正面临一场深刻的生产革命。一方面，ADC、双抗、融合蛋白等复杂分子的稳定性和生产难度激增，对工艺开发提出了远超传统抗体的要求。质量源于设计（QbD）理念的深入，使得生产工艺不再是附属环节，而是直接决定了创新药能否成功上市及商业化的核心能力；另一方面，全球药品定价承压，降本增效从可选项变为生存发展必答题。创新药行业共同面临着成本、质量、效率、灵活性的多重压力。CDMO随之陷在一种矛盾的...
Source Link全球生物制药正面临一场深刻的生产革命。一方面，ADC、双抗、融合蛋白等复杂分子的稳定性和生产难度激增，对工艺开发提出了远超传统抗体的要求。质量源于设计（QbD）理念的深入，使得生产工艺不再是附属环节，而是直接决定了创新药能否成功上市及商业化的核心能力；另一方面，全球药品定价承压，降本增效从可选项变为生存发展必答题。创新药行业共同面临着成本、质量、效率、灵活性的多重压力。CDMO随之陷在一种矛盾的...
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