治疗性多肽分析

Characterize and optimize therapeutic peptide programs with im体育APP’s deep bench of advanced technology and understanding of biological chemistry while generating characterization data required to meet crucial regulatory milestones.

肽治疗, 再加上化学合成的进步, 是否打开了通往新发现机会的新大门, 考虑到它们独特的混合属性, 简单的后期生产, 低制造成本. Peptide therapeutics are a prominent and impactful class of pharmaceuticals, 特别是用于治疗某些代谢疾病, 癌症, 以及传染病. Therapeutic peptides play a critical role as signaling molecules and hormones, and they continue to be valuable for interventions that closely mimic native interactions. 对于小公司, 进入门槛也较低, 因为不需要复杂的生物制造.

Although the barriers to entry are lesser, therapeutic peptides pose a number of challenges. Naturally occurring peptides can suffer from low 生物利用度, 化学和物理不稳定性, 膜渗透性差, 以及快速的新陈代谢和排毒. 另外, potentially hazardous residual components can be produced when peptides are manufactured through chemical synthesis, 要求识别, 控制, and mitigation strategies to be in place before production can be scaled. 而这个分子相对容易获得, companies pursuing peptide therapeutics do need access to specialized instruments, 方法, and expertise to complete the necessary analytical testing for regulatory filings and future commercialization. As programs advance, there is also room for greater efficiencies to expedite the path-to-market. These are just some of the areas where im体育APP’s peptide analysis capabilities can make a major impact.

Overcome challenges and expedite path-to-market with im体育APP’s comprehensive peptide analysis suite of services which have been built to maximize efficiencies, 重点关注肽的稳定性和功效. Using a combination of technology and deep understanding of biological chemistry, we can help you characterize and optimize your therapeutic peptide program, 同时生成法规遵从性所需的数据.

多肽分析方法和能力

Peptides have unique properties and analytical needs and can be filed with health agencies as a small molecule, 具有小蛋白分子特性. Strengthen your regulatory submission strategy with im体育APP’s expert regulatory and scientific guidance regarding the best approach for each program, 还有化验结果, 工具, 以及提供高度可靠结果所需的技术.

A deep understanding of chemical synthesis residuals and how to identify and quantify their presence underpins our therapeutic peptide analysis service offerings. Our consultative teams of scientific and regulatory experts have the biochemical knowledge needed to develop optimal, scalable 方法 to characterize and select specification ranges. im体育APP is adept at developing and executing innovative analytical 方法 that get to the heart of your therapeutic. Knowing the challenges associated with peptide activity and stability, our team can expertly access each peptide material to help you collect relevant data as you optimize your lead compounds for features such as half-life, 生物利用度, 目标交付. Leading biopharmaceutical organizations rely on im体育APP to provide best-in-class support with data, 文档, 分析证书的符合性, 第1, bla和其他法规要求.

治疗性肽分析服务

• 强制降解研究
• Residual organic solvent determination per USP <467>
• Purity/Potency assessment by HPLC (reversed-phase, size exclusion, ion-exchange, etc.)
• Purity assessment by capillary electrophoresis (CE, CGE, cIEF)
• Clinical samples preparation and testing for pharmacodynamics and pharmacokinetics studies by multiple reactions monitoring and LC-MS/MS
• 细胞培养的体外细胞效力
• 体外活性测定方法的发展
• 残留宿主细胞蛋白分析
• SDS-PAGE和Western Blot

仪表

• 毛细管电泳(CE, Protein Simple Maurice)
• Ultra-performance liquid chromatography (UPLC, Agilent) with UV-DAD and FLD
• High-performance liquid chromatography (HPLC, Agilent) with UV-DAD, Sedex, Varian, ELSD
• Dionex ICS-3000离子色谱系统
• 西弗斯总有机碳分析仪
• 安捷伦7500ce ICP-MS
• AB Sciex Triple Quadrupole API 2000 and 3000 Mass Spectrometers
• Waters Acquity UPLC with Xevo G2-S Quadrupole Time of Flight (QTOF)
• 哺乳动物细胞培养设施
• 碳稳定室(自定义设置)
• Metrohm 899KF卡尔费希尔电量计
• Perkin-Elmer Spectrum 65 and Spectrum 100 Fourier Transform Infrared Spectrometers (FTIR)
• 珀金埃尔默Lambda 365紫外/可见分光光度计
• 荧光 & 紫外线板阅读器

im体育APP优势

Leading healthcare brands trust im体育APP’s unparalleled ability to understand the unique needs of peptide programs throughout the entire drug development life cycle. Strengthen your peptide therapeutic program with our deep understanding of the identification and quantitation of chemical synthesis residuals and novel method development and validation for superior characterization and optimization at scale. Successfully navigate regulatory submissions with im体育APP’s consultative experts, 管理专业知识, 以及如何最好地处理每个项目的指导, 还有化验结果, 工具, 以及提供高度可靠结果的技术.

For more information about im体育APP’s comprehensive suite of therapeutic peptide services, 或者要求报价, 立即im体育APP.