Ducry Laurent
Lonza Ltd, Visp, Switzerland.
Methods Mol Biol. 2012;899:489-97. doi: 10.1007/978-1-61779-921-1_29.
Advances in antibody-drug conjugates (ADCs) will permit sensitive discrimination between healthy and cancer cells. Promising clinical results generated much hope that this targeted prodrug therapy will offer more effective treatment options to patients. Manufacturing such highly potent biopharmaceuticals presents a series of unique challenges. Some specific skills required for the process development and production of ADCs are discussed. In addition to the accuracy and reliability needed to handle these potent and costly materials, coworker safety and equipment cleaning are of particular importance. The ideas and concepts shared in this article are based on the experience that Lonza has gained in the ADC field since 2004.
抗体药物偶联物（ADC）的进展将使人们能够灵敏地区分健康细胞和癌细胞。令人鼓舞的临床结果让人们满怀希望，认为这种靶向前体药物疗法将为患者提供更有效的治疗选择。生产这类高效生物制药面临一系列独特的挑战。本文讨论了ADC工艺开发和生产所需的一些特定技能。除了处理这些强效且昂贵的材料所需的准确性和可靠性外，同事的安全和设备清洁尤为重要。本文分享的观点和理念基于龙沙自2004年以来在ADC领域积累的经验。
