im体育APPim体育平台app下载领先的专业知识, 方法, and purpose-built laboratories help to guide a steady, efficient path through regulatory approval for monoclonal antibody (mAb) therapies, the fastest-expanding class of protein therapeutics.
To build a lasting therapeutic franchise, leading healthcare brands must actively push for the very best in safety and efficacy while bringing therapies to patients as quickly as possible. Monoclonal antibody therapies have significant potential, 但它们也带来了重大风险, reinforcing the need for a partnership with trusted a CDMO that excels in monoclonal antibody characterization and analysis.
When targeted monoclonal antibodies are cloned from immune cells, a mass of high-affinity molecules are released that can bind vital antigens to everything from cancer cells to pathogens. 然而, 免疫原性是一个持续的挑战, and competition in the market is growing with the introduction of 生物仿制药. 在im体育APP, 我们总是领先一步, exceling in QC-minded monoclonal antibody characterization and analysis. We offer a range of critical analytical tests to ensure the highest safety, 再现性, and yield prior to large-scale biomanufacturing. 作为一个真正的伙伴, we advise and work alongside clients to develop a robust data package and efficient regulatory submission strategy.
Monoclonal antibody characterization capabilities
- 浓度/屈服的决心
- 纯洁的评估
- 蛋白质鉴定服务
- 强制降解研究
- 细胞效力和功效
- 糖基化的决心
- Post-translational modification determination
- 宿主细胞蛋白杂质检测
- 微量金属分析
- 工艺杂质检测
- 细胞培养基验证
Industry-leading support for monoclonal antibody specificity and sensitivity testing
在接下来的十年里, the global therapeutic antibody market is expected to double, partly due to the addition of emerging technologies such as phage display. In addition to navigating established analytical challenges, including screening multitudes of clonal variants for specificity, drug developers and researchers must be proactive about the scalability of process 方法.
im体育APP’s scientists understand the impact of solubility, 稳定, and distribution in monoclonal antibody development. 具有积极主动的qc思维, our teams work alongside clients to pre-empt manufacturing challenges, ensuring a holistic view of cell productivity and critical quality attributes is maintained throughout the entire engagement. Even with the additional complexities brought on by antibody humanization and glycosylation, we generate needed data efficiently and effectively, helping companies reach their commercial goals.
im体育APP优势
im体育APP is committed to providing comprehensive scientific and regulatory support to the world's leading healthcare brands as they develop and bring leading-edge monoclonal antibody therapies to market. From optimized method development and validation for long-term manufacturing efficiency, to providing guidance on data and documentation needed to meet regulatory requirements the first time around, im体育APP’s full-service solutions extend across the entire product development lifecycle. Facilitate a smooth transition as you prepare to manufacture at scale and realize the full potential of your mAb with our skilled tech transfer capabilities.
For more information about im体育APP’s monoclonal antibody (mAb) analysis and characterization services or to request a quote, im体育APP 今天.
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Biopharmaceuticals and Biologics 分析
im体育APP’s significant expertise in all stages of biologics R&D, from in-house protein biochemistry and molecular biology to cellular biology and QC experience, supports the entire product development life cycle.
治疗性蛋白分析
im体育APP provides a variety of therapeutic protein analysis and characterization services to design molecule-specific analytical strategies in support of IND and BLA regulatory pathways.
细胞培养 & 基于细胞的生物检测服务
im体育APP's cellular assay experts provide best-in-class cell culture and cell-based bioassay services for biologic drug discovery and development programs.
发现生物学
Establish a strong foundation for commercially successful therapies and advance from concept to candidate. Accelerate pre-clinical drug discovery with a large number of biochemical and cell-based assays.