第六章。影响多肽治疗生产可持续性的经济和环境因素

E. Lax, T. Shah
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引用次数: 2

摘要

多肽治疗药物的前景是光明的。医学适应症的范围正在扩大,多肽治疗药物获得批准的速度正在增加。新的配方和替代的递送方式正在克服许多肽类药物的固有弱点。从许多角度来看,肽疗法受益于生物制剂的成功。然而,考虑到过去20-30年该行业的整合,基于肽的新化学实体(NCEs)的独立合同生产的可持续性在临床试验中获得批准的产品和候选产品中受到质疑。目前,只有少数几家公司从事这种专门类型的制造活动。本章分析了合并的原因,并检查了影响肽治疗制造的当前经济和环境问题。
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Chapter 6. Economic and Environmental Factors Affecting the Sustainability of Peptide Therapeutic Manufacturing
The outlook for peptide therapeutic drugs is bright. The range of medical indications is expanding and the rate at which peptide therapeutic drugs are being approved is increasing. New formulations and alternative delivery modalities are overcoming many of the inherent weaknesses of peptide-based pharmaceuticals. From many perspectives, peptide therapeutics are benefiting from the success of biologics. However, the sustainability of independent contract manufacturing of peptide-based new chemical entities (NCEs) for approved products and candidates in clinical trials is open to question given the consolidation in the industry over the last 20–30 years. At present, this specialized type of manufacturing activity is performed by only a few companies. This chapter analyzes the causes of the consolidation and examines the current economic and environmental issues that affect peptide therapeutic manufacturing.
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Peptide Therapeutics: Fundamentals of Design, Development, and Delivery Chapter 5. Peptide Manufacturing Methods and Challenges Chapter 2. Regulatory Perspective on Synthetic Peptides in Europe Chapter 13. Assessing the Impact of Functional Excipients on Peptide Drug Product Attributes During Pharmaceutical Development Chapter 9. Impurity Characterization and Quantification by Liquid Chromatography–High-resolution Mass Spectrometry
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