我们的客户开发安全, efficacious products with confidence thanks to the high 质量 data we deliver as their partners in Biologics and Advanced Therapy Medicinal 产品s (ATMPS) such as cell and gene therapy. im体育APP's experience in ATMPS and particularly biological therapeutics span from R&D到CMC的活动，以支持IND和BLA申请, 商业化, 以及上市后产品生命周期管理.
What are the key challenges on the path to biologics and ATMPs 商业化?
生物制剂和atmp现在代表了现代治疗的主要类别, as the healthcare landscape has undergone a massive shift toward biopharmaceutical drugs over the past few decades. 尽管增长迅速， 商业化的道路是瓶颈 by the significant costs associated with Chemistry, Manufacturing, and Control requirements. This is especially true for companies lacking the capacity and know-how in-house to develop and execute necessary analytical methods that meet regulatory intent.
im体育APP生物制剂和ATMP分析的主要好处是什么?
当您与im体育APP合作进行生物制剂分析时，您将能够:
- 通过更高效的流程获得竞争优势: As a trusted biopharma contract research organization (CRO) and contract testing laboratory (CTL), im体育APP与我们的客户合作以提高效率, 降低成本, 打破障碍, ensuring customers have the crucial data needed each step of the way during drug development, 从发现到提交监管文件等等.
- 自信地向机构提交可靠的数据: Our clients trust that we’ll deliver the critical data they need and answer any questions they have along the way. 也可以进入我们装备精良的实验室, you can tap into our team’s expertise in all stages of biologics and ATMP testing, 由R张成&D走向商业化. Our rapid design and development of robust cellular potency or chromatography methods for complex molecules helps clients obtain the pivotal data necessary for regulatory submissions and release testing.
- Receive tailored, phase-appropriate testing services that meet your exact needs: im体育APP’s teams of consultative experts have far-reaching experience working with a wide range of biologic drug products and modalities such as:
- 重组蛋白
- 重组蛋白
- 单克隆抗体(mab)
- 双特异性抗体
- 抗体-药物偶联物
- 肽
- 细胞和基因治疗产品.g. 腺相关病毒和慢病毒相关疗法)
- 癌症疫苗
- 微生物组或其他细菌衍生产品.
im体育APPim体育平台app下载领先的生物制剂测试 & 分析
我们的im体育平台app下载领先的, 有经验的科学家可以发展, 优化, 并转移适合生物制剂的分析方法, as well as carry out phase-appropriate method validation and raw material analyses for both mammalian and microbial expression systems.
重组蛋白和酶: Proteins and enzymes can be active ingredients in replacement therapies or as a reagent in a diagnostic and molecular biology kit. CMC strategies for proteins and enzyme replacement therapies can be incredibly diverse. im体育APP could be your CMC partner while providing you with the analytical solutions for a successful filing.
单克隆抗体 代表了一大类生物疗法. Common analytical methods to analyze mAbs therapeutics include mass verification by QTOF, HPLC纯度, 免疫反应性测定.
肽: With properties that land somewhere between small molecules and proteins, 多肽有其自身的分析挑战. 多肽的结构可以是一个简单的线圈, 如果它们呈环状结构，就会更复杂, 或者它们形成低聚物并有聚集的倾向. im体育APP has the experience to develop and validation robust liquid chromatography methods to analyze peptide assay and related substances. Mass verification by LC-QTOF or immunoreactivity by dot blot are used for identification of peptides.
基因治疗 & AAV载体: Biotechnological advancements in the past few years have gained momentum in regulatory agency made room for safer and more effective gene therapies many of which use adeno-associated viruses (AAV) as viral vectors. 然而, determining viral vector 纯度 and transduction efficiency remains a significant analytical challenge for many innovators. 在这里, im体育APP can help companies develop the right method for each unique AAV product using our proteomics experience and extensive 质谱分析 availability, BioRad数字液滴(ddPCR), 高效液相色谱配备RI, 蒸发光散射检测器, 计算机辅助设计, 紫外检测器, 简单毛细管电泳系统, 细胞培养设备.
常用工艺杂质测试: im体育APP has developed analytical methods to detect and quantify common impurities from upstream and downstream biologics manufacturing processes. Common impurities include host cell DNA, host cell protein, Iodixanol, Poloxomer, CsCl, etc. im体育APP 以获取杂质的完整列表和相关方法.
生物制剂试验方法 & 技术
- Custom designed method development and validation for non-compendial methods utilizing chromatography, 质谱分析, 和生物
- HPLC (计算机辅助设计, IR, 蒸发光散射检测器, CD, DAD, FLD, UV检测器)
- LC-MS/MS (Agilent QQQ, Sciex QQQ, Thermo Orbitrap)
- LC-QTOF
- 气相
- gc - MS / MS
- 细胞培养
- ddPCR
- 板的读者
- 免疫测定
- 毛细管电泳(CE, CE- sds by Protein Simple)
- sds - page
- 免疫印迹
- 细胞效价测定
- 比活性，酶活性测定
- 肽图
- 自底向上的蛋白质组学
- 自顶向下质量测定
- 翻译后修饰分析
im体育APP优势
客户依靠im体育APP的专业知识来确保安全, 质量, 纯度, and potency of novel biologics throughout the product development life cycle. Our team of experienced scientists stay up to date with the latest scientific breakthroughs 监管指导, ensuring that your large molecule development and manufacturing programs meet rigorous safety, 质量, 功效标准.
For more information about im体育APP’s biologics 分析 or to request a quote, im体育APP 今天.
了解更多
疫苗的分析
当你研制疫苗时, having assurance that they are safe is a critical regulatory requirement. im体育APP提供疫苗分析和安全测试.
基因治疗
im体育APP uses a wide range of orthogonal analytical methods and capabilities to ensure the safety, 身份, 质量, 基因疗法的纯度和强度.
单克隆抗体(mAb)鉴定 & 分析
im体育APP’s phase-appropriate monoclonal antibody (mAb) characterization and analytics services are tailor-made to meet your needs throughout the biopharmaceutical product lifecycle.
治疗性蛋白分析
im体育APP provides a variety of therapeutic protein 分析 and characterization services to design molecule-specific analytical strategies in support of IND and BLA regulatory pathways.
生物制剂测试挑战的资源
Getting Ahead of Industry Expectations for Biological Therapeutics 测试
在本文中, you'll learn some insight into three different pressures creating changes in industry standards that ultimately impact safety testing in biological therapeutics.
生物制品CMC方法
Click the orange "view methods" button for the complete list of qualified biologics CMC platform methods we offer.