Our clients develop safe, 作为他们在生物制剂和先进治疗药物(ATMPS)(如细胞和基因治疗)领域的合作伙伴，我们提供高质量的数据，使他们对有效的产品充满信心. im体育APP在ATMPS，特别是生物治疗方面的经验从R&D to CMC activities to support IND and BLA filings, commercialization, and post-marketing product lifecycle management.
生物制剂和atmp商业化道路上的主要挑战是什么?
Biologics and ATMPs now represent a major class of modern therapeutics, 在过去的几十年里，医疗保健领域经历了向生物制药的巨大转变. Despite this growth, the path to commercialization is bottle-necked 与化学，制造和控制要求相关的重大成本. 对于那些内部缺乏能力和专业知识来开发和执行符合监管意图的必要分析方法的公司来说，情况尤其如此.
What are the key benefits of im体育APP biologics and ATMP 分析?
当您与im体育APP合作进行生物制剂分析时，您将能够:
- Gain a competitive edge through a more efficient process作为值得信赖的生物制药合同研究机构(CRO)和合同测试实验室(CTL), im体育APP partners with our customers to increase efficiency, cut down on cost, and break down barriers, 确保客户在药物开发的每一步都能获得所需的关键数据, from discovery to regulatory submissions and beyond.
- Confidently submit robust data to agencies我们的客户相信我们会提供他们需要的关键数据，并回答他们在此过程中遇到的任何问题. Along with access to our purposefully equipped labs, 您可以利用我们团队在生物制剂和ATMP测试的各个阶段的专业知识, spanning from R&D to commercialization. 我们快速设计和开发强大的细胞效价或复杂分子色谱方法，帮助客户获得监管提交和释放测试所需的关键数据.
- 接受量身定制的，适合阶段的测试服务，以满足您的确切需求im体育APP的咨询专家团队在处理各种生物药物产品和模式方面具有深远的经验，例如:
- Recombinant proteins
- Recombinant proteins
- Monoclonal antibodies (mAbs)
- Bispecific antibodies
- Antibody-drug conjugates (ADCs)
- 肽
- Cell and Gene Therapy 产品s (e.g. adeno-associated virus and lentivirus-associated therapeutics)
- Cancer vaccines
- Microbiome or other bacterially derived products.
im体育APP's industry-leading biologics testing & 分析
Our industry-leading, experienced scientists can develop, 优化, and transfer fit-for-purpose analytical methods for biologics, 同时对哺乳动物和微生物表达系统进行适当阶段的方法验证和原料分析.
Recombinant proteins and enzymes蛋白质和酶可以作为替代疗法的活性成分，也可以作为诊断和分子生物学试剂盒的试剂. 蛋白质和酶替代疗法的CMC策略可以非常多样化. im体育APP可以成为您的CMC合作伙伴，同时为您提供成功归档的分析解决方案.
Monoclonal antibodies represent a large class of biological therapeutics. 常用的分析方法包括QTOF的质量验证, 纯度 by HPLC, and assay by immunoreactivity.
肽: 具有介于小分子和蛋白质之间的特性, peptides have their own analytical challenges. The structure of a polypeptide could be a simple coil-coil, or more complex if they take on a cyclic ring structure, or if they form oligomers and have the tendency to aggregate. im体育APP具有开发和验证强大的液相色谱分析多肽试验和相关物质的经验. 采用LC-QTOF质量验证或免疫反应性斑点斑点法对多肽进行鉴定.
Gene Therapy & AAV载体在过去几年中，生物技术的进步在监管机构中获得了动力，为更安全、更有效的基因疗法提供了空间，其中许多疗法使用腺相关病毒(AAV)作为病毒载体. 然而, 确定病毒载体纯度和转导效率对许多创新者来说仍然是一个重大的分析挑战. 在这里, im体育APP可以利用我们的蛋白质组学经验和广泛的质谱可用性，帮助公司为每种独特的AAV产品开发正确的方法, BioRad digital droplet (ddPCR), HPLCs equipt with RI, 蒸发光散射检测器, 计算机辅助设计, UV detectors, Protein Simple capillary electrophoresis system, and cell culture facility.
Common Process Impurities 测试im体育APP开发了分析方法来检测和量化来自上游和下游生物制剂生产过程的常见杂质. 常见的杂质有宿主细胞DNA、宿主细胞蛋白、碘沙醇、百乐康、CsCl等. im体育APP for the full list of impurities and associated methods.
Biologics test methods & 技术
- 使用色谱法的非药典方法的定制设计方法开发和验证, mass spectrometry, and bioassays
- HPLC (计算机辅助设计, IR, 蒸发光散射检测器, CD, DAD, FLD, UV Detectors)
- LC-MS/MS (Agilent QQQ, Sciex QQQ, Thermo Orbitrap)
- LC-QTOF
- 气相
- gc - MS / MS
- Cell culture
- ddPCR
- Plate readers
- Immunoassays
- Capillary Electrophoresis (CE, CE-SDS by Protein Simple)
- sds - page
- Western Blot
- Cellular-based potency assays
- Specific activity, enzymatic activity assays
- 肽图
- Bottom-up proteomics
- Top-down mass determination
- Post-translational modification 分析
The im体育APP advantage
Customers rely on im体育APP’s expertise to ensure the safety, 质量, 纯度, 以及新生物制剂在整个产品开发生命周期中的效力. 我们经验丰富的科学家团队紧跟最新的科学突破 and regulatory guidance, 确保您的大分子开发和制造计划符合严格的安全要求, 质量, and efficacy standards.
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Vaccine 分析
As you develop your vaccines, having assurance that they are safe is a critical regulatory requirement. im体育APP provides vaccine 分析 and safety testing.
Gene Therapy
元件采用了广泛的正交分析方法和能力，以确保安全性, 身份, 质量, 纯度 and strength of gene therapies.
Monoclonal Antibody (mAb) Characterization & 分析
im体育APP的单克隆抗体(mAb)鉴定和分析服务是量身定制的，以满足您在整个生物制药产品生命周期中的需求.
