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, 商业化, 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 商业化 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?
When you partner with im体育APP for biologics 分析, you’ll be able to:
- 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, 降低成本, 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, 由R张成&D to 商业化. 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 蛋白质
- Recombinant 蛋白质
- Monoclonal antibodies (mAbs)
- Bispecific antibodies
- Antibody-drug conjugates (ADCs)
- 肽
- Cell and 基因治疗 产品s (e.g. adeno-associated virus and lentivirus-associated therapeutics)
- 癌症疫苗
- Microbiome or other bacterially derived products.
im体育APP's Industry-leading Team
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.
这正是im体育APP成为生物制剂分析无价合作伙伴的原因之一. Along with access to our purposefully equipped labs, our team has significant expertise in all stages of biologics R&D, 能够快速设计和开发强大的细胞效力或体外功效方法，以帮助获得监管提交和释放测试所需的关键数据. 作为值得信赖的生物制药合同研究组织(CRO)和合同开发与制造组织(CDMO), im体育APP partners with our customers to accelerate R&D efficiency 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.
im体育APP的咨询专家团队在广泛的生物药物产品和模式方面具有深远的经验，包括 蛋白质肽, monoclonal antibodies (mAbs), bispecific antibodies, antibody-drug conjugates (ADCs), adeno-associated virus and lentivirus-associated 基因疗法, cell therapies, cancer 疫苗, and microbiome or other bacterially derived products. Our industry-leading, experienced scientists can develop, 优化, and transfer fit-for-purpose analytical methods for biologics and biosimilars, 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.
生物制剂分析
肽 – With properties that land somewhere between small molecules and 蛋白质, peptides have a long history in human medicine. They also have their own bioanalytical challenges, particularly bioavailability and peptide stability. im体育APP了解与确定肽纯度和效力相关的独特挑战，并可以通过强制降解研究帮助您调查分子稳定性.
Proteins and enzymes -蛋白质和酶可以用于各种各样的治疗功能, from replacement therapies to diagnostics. im体育APP offers standard analytical services such as extra characterization, forced degradation studies, peptide map 分析, product-related and process-related 纯度 analyses, 具体的活动, in vitro cellular uptake method development and validation, 和更多的.
Monoclonal antibodies (mAbs) -单克隆抗体是发展最快的一类蛋白质疗法. Given their clinical (and economic) significance, im体育APP在mAb生物分析测试方面投入了特殊的资源和技术.
基因治疗 & AAV载体 -过去二十年生物技术的进步为更安全、更有效的基因疗法提供了空间, many of which use adeno-associated viruses (AAV) as viral vectors. 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可以帮助公司使用我们的Protein Simple毛细管电泳系统为每个独特的AAV产品开发正确的方法, UPLC功能, and cell culture facility; all while keeping clinical safety at the forefront.
生物仿制药 – As biopharmaceutics continue to grow in emphasis and importance, an increasing number of FDA-approved innovator biologics’ patents will expire. As a result, biosimilar development will expand significantly. While these materials can reach the market rapidly, 在证明这些新产品与最初批准的创新药物的相似性方面存在挑战. im体育APP了解新兴的潜在生物仿制药发展，并知道如何有效地比较生物制剂以确定相似性.
生物制药 & biologics test methods & 技术
- • 氨基酸分析
- • Assessment of 纯度, including AAV 纯度
- • Cell culture media validation
- • Cell-based bioassay services
- • Cellular potency/efficacy and toxicity
- • Determination of concentration/yield
- • Determination of viral particle titer
- • Forced degradation studies
- • Glycosylation determination
- • Impurities testing (process and host cell protein impurities, trace metals)
- • Method development (具体的活动, enzyme kinetics, PK/PD)
- • 肽图
- • Post-translational modification determination
- • Protein characterization
- • Raw materials and standards qualification
- • sds - page
- • Transduction efficacy
- • 免疫印迹
The im体育APP advantage
客户信赖im体育APP的综合生物制剂和生物制药生物分析, 分析, and characterization services to ensure the safety, 质量, 纯度, 以及新型生物制剂和生物仿制药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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疫苗的分析
As you develop your 疫苗, having assurance that they are safe is a critical regulatory requirement. im体育APP provides vaccine 分析 and safety testing.
基因治疗
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 基因疗法.
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.
