College of Pharmacy, The University of Texas at Austin, Austin, TX 78712, USA; Formulation Development Group, Regeneron Pharmaceuticals Inc., Tarrytown, NY 10591, USA(2).
College of Pharmacy, The University of Texas at Austin, Austin, TX 78712, USA.
Adv Drug Deliv Rev. 2021 May;172:183-210. doi: 10.1016/j.addr.2021.02.011. Epub 2021 Mar 8.
Recent advances in formulation sciences have expanded the previously limited design space for biological modalities, including peptide, protein, and vaccine products. At the same time, the discovery and application of new modalities, such as cellular therapies and gene therapies, have presented formidable challenges to formulation scientists. We explore these challenges and highlight the opportunities to overcome them through the development of novel formulations and drug delivery systems as biological solids. We review the current progress in both industry and academic laboratories, and we provide expert perspectives in those settings. Formulation scientists have made a tremendous effort to accommodate the needs of these novel delivery routes. These include stability-preserving formulations and dehydration processes as well as dosing regimes and dosage forms that improve patient compliance.
制剂科学的最新进展扩大了先前生物制剂（包括肽、蛋白质和疫苗产品）设计空间的局限性。与此同时，新治疗模式（如细胞疗法和基因疗法）的发现和应用也给制剂科学家带来了巨大的挑战。我们探讨了这些挑战，并通过开发新型制剂和药物输送系统作为生物固体来强调克服这些挑战的机会。我们回顾了工业界和学术界实验室的当前进展，并提供了这些领域的专家观点。制剂科学家为满足这些新型给药途径的需求做出了巨大努力。这些努力包括保持稳定性的制剂和脱水工艺，以及改善患者依从性的给药方案和剂型。
