基于细胞的效价检测

A scientist wearing gloves and a mask uses a pipette to prepare samples for pharmacokinetic/pharmacodynamic (PK/PD) analysis in a lab setting.

基于细胞的效价检测服务

基于细胞的效价检测是药物用于临床试验与商业化放行所必需的关键分析工具。这类方法的可获得性与适用性,为保障合规性与效率创造了重要契机,也受到监管机构的高度关注。 采用与研发阶段相适配的效价检测方法,对避免监管审批延误或临床试验搁置起到至关重要的作用。

凭借在获批药品商业化领域的丰富经验,康龙化成可为细胞治疗、基因治疗及生物制剂开发并验证符合药品生产质量管理规范(GMP)的基于细胞的效价测定方法提供端到端服务。我们可靠的基于细胞的效价检测服务,能够确保您的制药及生物制药产品符合监管标准,顺利实现上市放行。

康龙化成致力于在效价测定方法开发的任一阶段为您排忧解难,提供定制化的体外效价检测与基于细胞的测定方法开发解决方案。相信我们,选择我们作为合作伙伴,助你顺利取得监管审批,实现商业化成功。

选择康龙化成的理由:

  • 具备使获批药品商业化的丰富经验
  • 全⾯的端到端效价检测开发和验证
  • 精通符合GMP规范的细胞治疗、基因治疗及生物制剂相关工艺
  • 恪守监管合规要求,助力审批高效落地
In vitro potency assays and cell-based potency assays are crucial analytical tools required for releasing drug products for clinical testing and commercial use.

复杂的生物治疗产品需要通过多种检测形式开展效价测定。根据治疗产品的类型不同,检测内容可能包括评估基因递送能力(通过对病毒拷贝数进行定量分析实现)、感染性检测,或是治疗性基因的蛋白表达水平检测。同时,还需开展作用机制检测,以阐明该治疗分子本身特性所产生的生物学效应。

资源与技术支持

An image depicting a whitepaper advertisement for Pharmaron titled "Potency Assay Development for Cell and Gene Therapy Products." It includes a thumbnail of the whitepaper cover, an RNA/DNA strand background, and a "Download Whitepaper Below" button with the Pharmaron logo. The paper also touches on genetic toxicology insights.

应用于细胞与基因治疗药物的效价检测方法开发

Poster titled "Development of in vitro potency assays to evaluate early activation, Granzyme B secretion, and cytotoxicity of CAR-T cells," featuring detailed charts and graphs. The background includes purple and blue geometric patterns with the Pharmaron logo in the bottom right corner, underlining their expertise in bioanalytical development. A download button is provided below.

用于评估早期激活作用的
体外效价检测方法开发

Promotional image for Pharmaron's "Potency Assay Guide" ebook. Left section shows the ebook cover, with icons for safety, integrity, and results. Right section has "Potency Assay" text with a "Download eBook Below" button, overlaid on a DNA strand background that hints at bioanalytical development.

应用于细胞与基因治疗药物的效价检测电子书

A promotional poster displays scientific information on leveraging imaging technologies for drug potency testing in orthotopic and heterotopic tumor models. It includes text, graphs, and images related to Preclinical ADME studies. A "Download Below" button is visible, along with Pharmaron's logo.

运用IVIS活体成像技术
进行药效检测