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APP的im体育平台app下载领先团队
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.
This is just one of the reasons why im体育APP is an invaluable partner for biologics 分析. 也可以进入我们装备精良的实验室, 我们的团队在生物制剂研发的各个阶段都拥有丰富的专业知识&D, enabling the rapid design and development of robust cellular potency or in vitro efficacy methods to help obtain the pivotal data necessary for regulatory submissions and release testing. As a trusted biopharma contract research organization (CRO) and contract development and manufacturing organization (CDMO), im体育APP与我们的客户合作加速R&提高效率，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.
im体育APP’s teams of consultative experts have far-reaching experience working with a wide range of biologic drug products and modalities including 蛋白质肽, 单克隆抗体(mab), 双特异性抗体, 抗体-药物偶联物, 腺相关病毒和慢病毒相关 基因疗法细胞疗法，癌症 疫苗，以及微生物组或其他细菌衍生产品. 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和生物仿制药的分析方法, as well as carry out phase-appropriate method validation and raw material analyses for both mammalian and microbial expression systems.
生物制剂分析
肽 -具有介于小分子和蛋白质之间的特性, 多肽在人类医学中有着悠久的历史. 他们也有自己的生物分析挑战, 特别是生物利用度和肽稳定性. im体育APP understands the unique challenges associated with determining peptide 纯度 and potency and can help you investigate your molecules stability through 强制降解研究.
蛋白质和酶 – 蛋白质和酶 can be used for an incredibly diverse set of therapeutic functions, 从替代疗法到诊断. im体育APP提供标准的分析服务，例如额外的特性描述, 强制降解研究, 肽图分析, 产品相关和工艺相关的纯度分析, 具体的活动, 体外细胞摄取法的建立与验证, 和更多的.
单克隆抗体(mab) – Monoclonal antibodies represent the fastest growing class of protein therapeutics. 鉴于它们的临床(和经济)意义, im体育APP has devoted special resources and 技术 to mAb bioanalytical testing.
基因治疗 & AAV载体 – Biotechnological advancements in the past two decades have made room for safer 和更多的 effective 基因疗法, 其中许多使用腺相关病毒(AAV)作为病毒载体. 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 Protein Simple capillary electrophoresis system, UPLC功能, and cell culture facility; all while keeping clinical safety at the forefront.
生物仿制药 -随着生物制药的重要性和重要性不断提高, 越来越多的fda批准的创新生物制剂专利将到期. 因此，生物类似药的开发将显著扩大. 而这些材料可以迅速进入市场, there are challenges associated with proving the similarity of these new product to the originally approved innovator drug. im体育APP understands the emerging potential biosimilar development holds and knows how to efficiently compare biologics to determine similarity.
生物制药 & 生物制剂试验方法 & 技术
- • 氨基酸分析
- • 纯度评估，包括AAV纯度
- • 细胞培养基验证
- • 基于细胞的生物测定服务
- • 细胞效力/功效和毒性
- • 浓度/产率的测定
- • 病毒颗粒滴度测定
- • 强制降解研究
- • 糖基化的决心
- • 杂质检验(加工过程和宿主细胞蛋白质杂质、微量金属)
- • 方法开发(比活性，酶动力学，PK/PD)
- • 肽图
- • 翻译后修饰测定
- • 蛋白质的特性
- • 原材料和标准鉴定
- • sds - page
- • 转导功效
- • 免疫印迹
im体育APP优势
Customers rely on im体育APP’s comprehensive biologics and biopharmaceutical bio分析, 分析, 并提供鉴定服务，确保安全, 质量, 纯度, and potency of novel biologics and biosimilars 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.
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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
领先于im体育平台app下载对生物治疗测试的期望
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.