im体育APP’s consultative team of expert scientists work with customers to design molecule-specific analytical strategies for extensive analysis and characterization of proteins and therapeutic enzymes in support of IND and BLA regulatory pathways.
Proteins and enzymes play a critical role in human health and disease, which has led to protein therapeutics playing a central role in modern medicine. Proteins offer a wide range of benefits when compared to small molecule drugs, including more complex mechanisms and the ability to limit off-target effects through specificity. 此外, protein therapeutics are often well-tolerated by patients, 也可以用作诊断性生物标志物. Although orphan disease or 快-track regulatory pathways are available for many investigational protein investigational protein and enzyme therapeutics, there is a constant and growing need for streamlined, 具有成本效益的蛋白质分析.
减轻常见并发症和挑战, 包括蛋白质溶解度, 稳定, 分布, 以及给药途径, im体育APP’s scientists use a variety of refined protein characterization assays, in conjunction with specialized tools for protein quantification, 稳定性分析等. Our consultative scientists have the experience and expertise to help to identify issues unique to peptide and enzyme therapeutics, such as 翻译修饰s (PTM) and enzyme kinetics. im体育APP’s comprehensive protein analytics suite of services brings together a wide variety of methods, 包括氨基酸分析, 浓度/屈服的决心, 细胞效力和体外细胞培养, 糖基化的决心, 翻译修饰, 和更多的.
Please note while this section focuses on analytical services for proteins and enzymes, information regarding monoclonal antibodies (mAbs) is not included. Due to both their importance and differences compared to other protein classes, im体育APP’s antibody therapeutics offerings are detailed separately; see here for information about monoclonal antibody analytical services.
Comprehensive therapeutic protein and enzyme analysis and support
Leading biopharmaceutical organizations trust im体育APP’s deep bench of scientific expertise to advance therapeutic enzymes throughout the drug development lifecycle, depending upon our highly skilled teams of scientists to develop robust enzymatic activity assays and enzyme kinetics studies. We offer a comprehensive suite of services to support drug substance characterization for IND and BLA regulatory pathways, 包括分析方法开发, 强制降解研究, 阶段相适应的方法鉴定, 稳定的程序, 杂质识别, 以及产品质量调查. 此外, our strategic method development services enable the optimization of processes, 收益率, 在大规模生产之前的纯度.
im体育APP’s scientists collaborate with customers to determine the best analytical strategy to help them reach their goals, acting as a true partner and extension of their team. 另外, consultative regulatory experts also provide guidance around the data and documentation needed to demonstrate long-term safety at the preclinical level.
治疗性蛋白分析 and characterization services
- 氨基酸分析
- 浓度/屈服的决心
- Process-related and product-related purity assessment by U/HPLC (Reversed-phase, 大小排斥, 离子交换, 等.)
- 产品 purity assessment by capillary (gel) electrophoresis (CE and CGE)
- Charge heterogeneity and weighted pI determination by capillary isoelectric focusing (cIEF)
- SDS-PAGE / Western Blot
- 质谱法鉴定蛋白质
- Cellular potency and in vitro efficacy in cell culture
- 酶活性测定的发展
- 酶动力学研究
- 质谱法测定糖基化
- Post-translational modification determination by mass spectrometry and CE
- ELISA法分析宿主细胞蛋白杂质
- 微量金属分析 摘要利用
- Cell culture media characterization and qualification
- Analytical method development, validation, and transfer
- 阶段相适应的方法鉴定
- 生物制品质量调查
- Contaminant and 杂质识别 in large molecule therapies
- 蛋白质特性测定
- 蛋白定量
- Forced degradation studies of proteins and enzymes
- 治疗性蛋白质稳定性项目
im体育APP优势
im体育APP tailors bioanalytical testing to the needs of each specific large-molecule therapy, considering both the protein and manufacturing approach, ensuring the rapid assessment of biomolecule efficacy and swift delivery of an accurate certificate of authentication (COA), 让你按部就班地完成重要的里程碑. im体育APP’s QC-minded scientists help our customers analyze and develop materials to reach those significant milestones. 凭借我们对蛋白质疗法的深入了解, we can perform a multitude of state-of-the-art analytics to provide the answers you need, 快.
For more information about im体育APP’s protein analytics services or to request a quote, im体育APP 今天.
了解更多
生物制药和生物制品分析
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.
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.
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.