RTI International, Research Triangle Park, NC, USA.
Hum Vaccin Immunother. 2022 Apr 29;18(2):1940650. doi: 10.1080/21645515.2021.1940650. Epub 2021 Jun 30.
The use of antibodies in the treatment of lung diseases is of increasing interest especially as the search for COVID-19 therapies has unfolded. Historically, the use of antibody therapy was based on multiple targets including receptors involved in local hyper-reactivity in asthma, viruses and micro-organisms involved in a variety of pulmonary infectious disease. Generally, protein therapeutics pose challenges with respect to formulation and delivery to retain activity and assure therapy. The specificity of antibodies amplifies the need for attention to molecular integrity not only in formulation but also during aerosol delivery for pulmonary administration. Drug product development can be viewed from considerations of route of administration, dosage form, quality, and performance measures. Nebulizers and dry powder inhalers have been used to deliver protein therapeutics and each has its advantages that should be matched to the needs of the drug and the disease. This review offers insight into quality and performance barriers and the opportunities that arise from meeting them effectively.
抗体在肺部疾病治疗中的应用越来越受到关注，尤其是在 COVID-19 治疗方法的探索过程中。从历史上看，抗体治疗的应用基于多个靶点，包括哮喘局部高反应性相关的受体、各种肺部传染病涉及的病毒和微生物。通常，蛋白质治疗在保留活性和确保治疗效果方面，在制剂和给药方面都存在挑战。抗体的特异性增加了对分子完整性的关注，不仅在制剂方面，而且在肺部给药的气溶胶输送过程中也是如此。药物产品开发可以从给药途径、剂型、质量和性能衡量标准等方面进行考虑。雾化器和干粉吸入器已被用于输送蛋白质治疗药物，它们各有优势，应根据药物和疾病的需求进行匹配。本综述提供了对质量和性能障碍的深入了解，并探讨了有效应对这些障碍所带来的机遇。
