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Cell therapy products come from diverse sources and have complex biological characteristics. The production processes of different categories of cell therapy products, such as mesenchymal stem cells, NK cells, CAR-T cells, and induced pluripotent stem cells, involve the ex vivo culture of cells. Ex vivo cell culture inevitably involves changes in biological properties, alterations in biological safety, exogenous contamination, and cross-contamination, all of which severely impact the progress and success of research and production processes.
According to the guidelines such as the "Technical Guidelines for Research and Evaluation of Cell Therapy Products," "Technical Guidelines for Pharmaceutical Research and Evaluation of Human-Derived Stem Cell Products (Trial)," and "Technical Guidelines for Non-clinical Research and Evaluation of Gene-modified Cell Therapy Products (Trial)," researchers need to establish quality control strategies for various types of cell therapy products. Quality control should generally consider identification, biological potency, purity, impurities, cell quantity (e.g., live cell count, functional cell count), and general safety testing (such as sterility, mycoplasma, endotoxins, appearance, and other exogenous contaminants beyond cell counts). Additionally, depending on the characteristics of the cell therapy products, quality research and testing should include cell property analysis, specific and non-specific virus detection, viral vector reversion mutations (replicative virus testing), biological activity (clarifying the biological effects and mechanisms related to clinical treatment), and more.
Canvest Bio provides comprehensive quality testing services for cell and gene therapy (CGT) products.。
For non-gene-edited cell therapy products like mesenchymal stem cells, Canvest Bio can offer:
1.Microbiological Safety Testing: Establishing quality control plans for all aspects of raw and auxiliary materials, starting materials (such as production cells, microbial strains, etc.), and products to ensure that cells and cell products meet the quality requirements of no bacterial, fungal, mycoplasma, viral contamination, or microbial metabolic product contamination.
2.Biological Safety Testing: Establishing risk prediction or elimination strategies to ensure that cell therapy products do not produce carcinogenic, abnormal immune responses, or differentiation issues when introduced into the human body.
3.Biological Attribute Testing: Evaluating biological attributes such as cell identification, activity, purity, and uniformity to reduce risks caused by the diversity, heterogeneity, and complexity of various cell therapy products.
4.Biological Potency Testing: Assessing induced differentiation capacity, immune responses, secretion of relevant active substances, etc., to predict clinical therapeutic effects.
For gene-edited immune cell therapy products such as CAR-T cells, in addition to the general cell quality control tests mentioned above, it is necessary to consider risks introduced by the production plasmids, bacterial strains, plasmids, lentiviruses, and other special production processes, such as lentiviral vector reversion mutations (RCL testing), effects on target cells, secretion of specific factors, process-related impurities (e.g., magnetic beads), and product-related impurities (such as non-functional cell populations).
Canvest Bio’s comprehensive list of testing services for cell therapy products
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序号 |
类别(产品/项目/参数) |
产品/项目/参数 |
依据的标准（方法）名称及编号（含年号） |
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序号 |
名 称 |
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1 |
细胞鉴别试验 |
1.1 |
同工酶试验 |
生物制品生产检定用动物细胞基质制备及检定规程《中国药典》2020年版三部， 生物制品生产检定用菌毒种管理及质量控制、 生物制品生产检定用动物细胞基质制备及质量控制、生物制品病毒安全性控制《中国药典》2020年版三部 Code of Federal Regulation Title 9（9 CFR） Guidance for Industry :Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications |
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1.2 |
染色体核型分析法 |
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1.3 |
STR分析法 |
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1.4 |
细胞形态观察法 |
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1.5 |
细胞表面标记物检测--流式细胞术 |
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1.6 |
DNA条形码法 |
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1.7 |
种属鉴定-- PCR法 |
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1.8 |
RAPD法（随机扩增多态性DNA） |
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2 |
无菌检查 |
2.1 |
细菌、真菌无菌检查--薄膜过滤法 |
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2.2 |
细菌、真菌无菌检查--直接接种法 |
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2.3 |
分枝杆菌检查法 |
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3 |
支原体检查 |
3.1 |
支原体检查--琼脂培养法 |
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3.2 |
支原体检查--液体培养法 |
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3.3 |
支原体检查--DNA染色法 |
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4 |
内、外源病毒因子检查 |
4.1 |
细胞形态观察及血吸附试验 |
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4.2 |
体外不同指示细胞接种培养法 |
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4.3 |
动物体内接种法 |
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4.3.1 |
乳鼠脑内及腹腔接种法 |
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4.3.2 |
小鼠脑内及腹腔接种法 |
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4.3.3 |
豚鼠腹腔接种法 |
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4.3.4 |
家兔皮内及皮下接种法 |
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4.4 |
鸡胚接种法 |
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4.4.1 |
鸡胚卵黄囊接种法 |
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4.4.2 |
鸡胚尿囊腔接种及尿囊液血凝试验 |
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4.5.1 |
逆转录病毒检测--逆转录酶活性测定法 |
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4.5.2 |
逆转录病毒检测--透射电镜观察法 |
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4.5.3 |
逆转录病毒检测--感染性试验 |
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4.5.4 |
逆转录病毒样颗粒定量--透射电镜法 |
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4.5.5 |
逆转录病毒样颗粒定量--Q-PCR法 |
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4.6.1 |
鼠源性病毒检测--细胞试验 |
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4.6.2 |
鼠源性病毒检测--动物抗体产生试验 |
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4.6.3 |
鼠源性病毒检测--鸡胚感染试验 |
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4.6.4 |
鼠源性病毒检测--Q-PCR法 |
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4.7.1 |
人源病毒检测--免疫荧光法 |
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4.7.2 |
人源病毒检测--Q-PCR法 |
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4.8.1 |
牛源性病毒检测--细胞培养法 |
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4.8.2 |
牛源性病毒检测--荧光抗体检测法 |
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4.8.3 |
牛源性病毒检测--Q-PCR法 |
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4.9.1 |
鼠细小病毒检测--细胞培养法 |
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4.9.2 |
鼠细小病毒检测--Q-PCR法 |
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4.10.1 |
猪源性病毒检测--细胞培养法 |
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4.10.2 |
猪源性病毒检测--荧光抗体检测法 |
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4.10.3 |
猪源性病毒检测--Q- PCR法 |
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4.11.1 |
杯状病毒（Vesivirus 2117）检测--Q- PCR法 |
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5 |
成瘤性检查 |
5.1 |
动物体内接种法 |
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5.2 |
软琼脂克隆形成试验 |
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5.3 |
端粒酶活性检测--Q-PCR法 |
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6 |
致瘤性检查 |
6.1 |
动物体内接种法 |
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7 |
免疫学反应检测 |
7.1 |
淋巴细胞增殖抑制试验 |
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7.2 |
特定淋巴细胞亚群检测法（Th1,Th17,Treg） |
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7.3 |
淋巴细胞分泌TNF-α抑制试验 |
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8 |
生物学有效性评价 |
8.1 |
成骨细胞分化试验 |
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8.2 |
成软骨细胞分化试验 |
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8.3 |
成脂细胞分化试验 |
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9 |
细胞活性检测 |
9.1 |
细胞计数和细胞存活率检测法 |
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9.2 |
细胞生长曲线测定法 |
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9.3 |
细胞周期测定--PI染色法 |
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10 |
残留物检测 |
10.1 |
牛血清白蛋白残留检测法 |
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10.2 |
抗生素残留检测--培养法 |
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10.3 |
抗生素残留检测--酶联免疫法 |
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10.4 |
磁珠残留 |
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10.5 |
Human IL-2残留 |
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11 |
噬菌体污染检查 |
11.1 |
透射电镜观察--负染色法 |
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11.2 |
培养观察--噬斑法 |
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12 |
菌种鉴定 |
12.1 |
菌株染色观察--普通染色法 |
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12.2 |
菌株染色观察--革兰氏染色法 |
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12.3 |
菌落形态观察-培养法 |
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12.4 |
菌株抗生素抗性试验-培养法 |
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12.5 |
菌株生化特征分析--生化反应试验 |
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12.6 |
16SrRNA分析法 |
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12.7 |
18SrRNA分析法 |
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12.8 |
26SrRNA分析法 |
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12.9 |
ITS序列分析法 |
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13 |
细菌内毒素检测 |
13.1 |
凝胶法 |
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14 |
可复制型病毒检测 |
14.1 |
复制性逆转录病毒检测--细胞培养和 Q- PCR法 |
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14.2 |
复制性慢病毒检测--细胞培养和 Q- PCR/ELISA法 |
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15 |
细胞制剂检测 |
CAR+T细胞比例 CD3+细胞比例 生物学活性 磁珠残留 Human IL-2残留 NK细胞自然杀伤活性检测 NK细胞ADCC功能检测 NK激活性和抑制性受体检测GzmB,perforin,CD107表达水平检测 |
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16 |
其他检测项目 |
流式细胞术的绝对细胞计数方法 CCK-8法则定细胞群体倍增时间 细胞克隆形成率检测方法 MSC急性毒性及抗GVHD效果评价 基于RPA-cas技术的口腔支原体检测 基于LAMP技术的肺炎支原体的可视化检测 Lb-cas12a蛋白的原核表达及纯化 基于CRISPRCas系统的多种支原体核酸检测 mRNA含量ribogreen荧光检测 mRNA疫苗总抗体滴度ELISA检测法 mRNA疫苗中和抗体效价假病毒中和试验检测法 dsRNA杂质ELISA检测法 马源性病毒检查（3种） 禽源性病毒检查（3种） 昆虫细胞CO1条形码分析法 昆虫细胞螺原体qPCR检测 昆虫杆状病毒检测 昆虫黄病毒检测 昆虫诺达病毒检测 昆虫弹状病毒（内源性/外源性）检测 SV40大T抗原核酸序列检测 腺病毒5型EIA基因检测 胎畸瘤形成试验 |
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