Therapeutic Peptide Analysis

利用Element的先进技术和对生物化学的理解，表征和优化治疗肽程序，同时生成满足关键监管里程碑所需的表征数据.

Peptide therapies, coupled with advances in chemical synthesis, have opened new doors to new discovery opportunities, given their unique blend of properties, simple late-stage production, and low manufacturing costs. 肽治疗剂是一个突出的和有影响力的一类药物, notably as treatments for certain metabolic diseases, cancer, and infectious diseases. 治疗肽作为信号分子和激素发挥着至关重要的作用, 而且它们在密切模仿原生相互作用的干预中仍然很有价值. For smaller companies, the barriers to entry are also lower, as complex biomanufacturing is not required.

虽然进入壁垒较小，但治疗性肽提出了许多挑战. 天然存在的多肽可能存在生物利用度低的问题, chemical and physical instability, poor membrane permeability, and fast metabolism and elimination. Additionally, 当多肽通过化学合成制造时，可能会产生潜在的有害残余成分, requiring identification, control, 在生产规模扩大之前，必须制定缓解战略. While this molecule is relatively accessible, 从事肽治疗的公司确实需要获得专门的仪器, methods, 以及为监管备案和未来商业化完成必要分析测试的专业知识. 随着项目的推进，还有提高效率的空间，以加快进入市场的步伐. 这些只是Element的肽分析能力可以产生重大影响的一些领域.

克服挑战，加快进入市场的途径与im体育APP的全面肽分析套件的服务，已经建立了最大限度地提高效率, with a focus on peptide stability and efficacy. 将技术与对生物化学的深刻理解相结合, 我们可以帮助您描述和优化您的治疗肽程序, while generating the data needed for regulatory compliance.

Peptide analysis methods and capabilities

多肽具有独特的性质和分析需求，可以作为小分子提交卫生机构, with small protein molecular characteristics. 通过Element关于每个项目最佳方法的专家监管和科学指导，加强您的监管提交策略, along with the assays, tools, and techniques needed to deliver highly reliable results.

对化学合成残留物的深刻理解以及如何识别和量化它们的存在是我们治疗肽分析服务的基础. 我们的科学和监管专家咨询团队拥有开发最佳生物化学所需的知识, 可扩展的方法来表征和选择规格范围. Element擅长开发和执行创新的分析方法，达到您治疗的核心. 了解与肽活性和稳定性相关的挑战, 我们的团队可以熟练地访问每种肽材料，帮助您收集相关数据，以优化您的先导化合物的特征，如半衰期, bioavailability, and target delivery. 领先的生物制药组织依靠Element提供一流的数据支持, documentation, and compliance for certificates of analysis, INDs, BLAs and other regulatory requirements.

Therapeutic peptide analysis services

Forced degradation studies
Residual organic solvent determination per USP <467>
HPLC纯度/效价评价(反相，大小排除，离子交换等).)
毛细管电泳(CE, CGE, cIEF)纯度测定
采用多重反应监测和LC-MS/MS技术进行临床样品制备及药效学和药代动力学研究
In vitro cellular potency in cell culture
In vitro activity assay method development
Residual host cell protein analysis
SDS-PAGE and Western Blot

Instrumentation

Capillary electrophoresis (CE, Protein Simple Maurice)
超高效液相色谱(UPLC, Agilent)与UV-DAD和FLD
高效液相色谱(HPLC, Agilent)， UV-DAD, Sedex, Varian, ELSD
Dionex ICS-3000 Ion Chromatography System
Seivers Total Organic Carbon Analyzer
Agilent 7500ce ICP-MS
AB Sciex三重四极杆API 2000和3000质谱仪
搭载Xevo G2-S四极杆飞行时间(QTOF)的Waters Acquity UPLC
Mammalian cell culture facility
Caron stability chambers (custom settings)
Metrohm 899KF Karl Fisher Coulometer
珀金-埃尔默光谱65和光谱100傅立叶变换红外光谱仪(FTIR)
Perkin Elmer Lambda 365 UV/Vis Spectrophotometer
Fluorescent & UV plate readers

The Element advantage

领先的医疗保健品牌信任Element在整个药物开发生命周期中了解肽项目独特需求的无与伦比的能力. 通过我们对化学合成残留物鉴定和定量的深刻理解，以及对大规模表征和优化的新方法开发和验证，加强您的肽治疗计划. 与Element的咨询专家一起成功处理监管文件, regulatory expertise, and guidance as to how to best approach each program, along with the assays, tools, and techniques to deliver highly reliable results.

有关Element的综合治疗肽服务的更多信息, or to request a quote, contact us today.