Abstract：
The Peptide therapeutics market was evaluated to be around USD 45.67 BN in 2023 and is projected to witness massive growth at a CAGR of around 5.63 % from 2024 to 2032 (USD 80.4 BN). Generic peptides are expected to reach USD 27.1 billion by 2032 after the patent monopoly of the pioneer peptides expires, and generic peptides become accessible. The generic manufacturers are venturing into peptide-based therapeutics for the aforementioned reasons. There is an abundance of material accessible regarding the characterization of peptides, which can be quite confusing for researchers. The FDA believes that an ANDA applicant may now demonstrate that the active component in a proposed generic synthetic peptide drug product is the \"same\" as the active ingredient in a peptide of rDNA origin that has previously been approved. To ensure the efficacy, safety, and quality of peptide therapies during development, regulatory bodies demand comprehensive characterization utilizing several orthogonal methodologies. This article elaborates the peptide characterization by segmenting into different segments as per the critical quality attribute from identification of the peptide to the physicochemical property of the peptide therapeutics which will be required to demonstrate the sameness with reference product based on the size of the peptide chain and molecular weight of the peptides. Article insights briefly on each individual technique and the orthogonal techniques for each test were explained. The impurities requirements in the generic peptides as per the regulatory requirement were also discussed.
摘要：
肽疗法市场在2023年被评估为约45.67BN，预计从2024年到2032年将以约5.63%的复合年增长率(80.4BN)大幅增长。在先锋肽的专利垄断到期后，到2032年，通用肽预计将达到271亿美元，和通用肽变得可访问。出于上述原因，通用制造商正在冒险进入基于肽的治疗剂。关于肽的表征，有大量的材料可获得，这对研究人员来说是相当混乱的。FDA认为，ANDA申请人现在可以证明，拟议的通用合成肽药物产品中的活性成分与先前已批准的rDNA来源的肽中的活性成分“相同”。为了确保疗效，安全,以及开发过程中肽疗法的质量，监管机构要求利用几种正交方法进行全面表征。本文通过根据从肽的鉴定到肽治疗剂的物理化学性质的关键质量属性分段成不同的片段来阐述肽表征,这将需要基于肽链的大小和肽的分子量来证明与参考产品的同一性。简要解释了关于每种单独技术和每种测试的正交技术的文章见解。还讨论了根据监管要求的通用肽中的杂质要求。
