Calibration Curve enables Proper Quantitation and Suitable Analytical Assay Sensitivity

We set-up and validate robust analytical methods for quantitation of your drugs and biomarkers, considering distinct assay factors such as analytical specificity, selectivity, and sensitivity. Analytical specificity represents the assay’s ability to measure a specific analyte within a sample with matrix and ingredients. Analytical selectivity defines the capability to separate and detect the analyte within a complex matrix without any interference from other components. Analytical sensitivity asserts the smallest amount of an analyte that can be measured in an assay correctly.

Likewise, our team utilizes a suitable calibration curve to determine the concentration of your analyte in an unknown sample. This analysis requires a comparison of unknown samples to a set of standard samples of known concentration and quality controls processed within the same matrix. Sometimes, these assays become very challenging – especially if the unknown sample is endogenous, environmental, or biologically complex. That said, our veteran scientists at NorthEast BioLab are quite familiar with these method and analysis hurdles and capably resolve such issues if/when they arise.

Our team of scientists works diligently to base our research and studies as per the boundaries outlined within your analytical assay. We tenaciously pursue precision and accuracy for our methods to ensure reliable and reproducible results. We rely extensively on the triple quadrupole mass spectrometry and ligand binding detection techniques as they usually deliver superior sample analysis results.

Neobiolab免疫原性测定对于测量针对治疗性蛋白质的免疫反应至关重要。这些测试还可以测量各种抗药物抗体（ADA）和可溶性蛋白质生物标志物。这些测量结果会影响剂量选择和药物的安全性。在ADA分析过程中量化的可溶性蛋白质生物标记物可以揭示靶标参与，提供作用机制并预测与药物相关的免疫反应。

用于免疫原性测定的样品包含复杂的基质，可能会产生相当大的干扰并导致不准确。因此，科学家制定了减少免疫原性测试干扰并准确支持治疗性抗体和其他候选药物开发的策略。

NorthEast Biolab在为生物技术和制药公司设计，优化和验证ADA分析方面拥有15年以上的经验。我们分别在临床前和临床阶段对新的生物制剂实施GLP和GCP评估。我们的资深科学家致力于各种免疫原性测试分析，以提供高度敏感和选择性的方法。

在免疫原性测定开发过程的所有阶段，我们的服务均包括以下步骤：

• 抗体的纯化，修饰和采购

• 免疫原和抗原制备

• 细胞系形成

• 免疫测定的开发和优化

• 试剂准备

• 抗药物抗体筛选

• 滴定和同型