Jiachang Biological - biotechnology services and research and development as one of the high-tech enterprises
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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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序號 |
類別(產(chǎn)品/項(xiàng)目/參數(shù)) |
產(chǎn)品/項(xiàng)目/參數(shù) |
依據(jù)的標(biāo)準(zhǔn)（方法）名稱及編號（含年號） |
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序號 |
名 稱 |
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1 |
細(xì)胞鑒別試驗(yàn) |
1.1 |
同工酶試驗(yàn) |
生物制品生產(chǎn)檢定用動物細(xì)胞基質(zhì)制備及檢定規(guī)程《中國藥典》2020年版三部， 生物制品生產(chǎn)檢定用菌毒種管理及質(zhì)量控制、 生物制品生產(chǎn)檢定用動物細(xì)胞基質(zhì)制備及質(zhì)量控制、生物制品病毒安全性控制《中國藥典》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 |
染色體核型分析法 |
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1.3 |
STR分析法 |
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1.4 |
細(xì)胞形態(tài)觀察法 |
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1.5 |
細(xì)胞表面標(biāo)記物檢測--流式細(xì)胞術(shù) |
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1.6 |
DNA條形碼法 |
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1.7 |
種屬鑒定-- PCR法 |
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1.8 |
RAPD法（隨機(jī)擴(kuò)增多態(tài)性DNA） |
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2 |
無菌檢查 |
2.1 |
細(xì)菌、真菌無菌檢查--薄膜過濾法 |
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2.2 |
細(xì)菌、真菌無菌檢查--直接接種法 |
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2.3 |
分枝桿菌檢查法 |
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3 |
支原體檢查 |
3.1 |
支原體檢查--瓊脂培養(yǎng)法 |
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3.2 |
支原體檢查--液體培養(yǎng)法 |
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3.3 |
支原體檢查--DNA染色法 |
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4 |
內(nèi)、外源病毒因子檢查 |
4.1 |
細(xì)胞形態(tài)觀察及血吸附試驗(yàn) |
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4.2 |
體外不同指示細(xì)胞接種培養(yǎng)法 |
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4.3 |
動物體內(nèi)接種法 |
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4.3.1 |
乳鼠腦內(nèi)及腹腔接種法 |
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4.3.2 |
小鼠腦內(nèi)及腹腔接種法 |
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4.3.3 |
豚鼠腹腔接種法 |
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4.3.4 |
家兔皮內(nèi)及皮下接種法 |
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4.4 |
雞胚接種法 |
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4.4.1 |
雞胚卵黃囊接種法 |
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4.4.2 |
雞胚尿囊腔接種及尿囊液血凝試驗(yàn) |
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4.5.1 |
逆轉(zhuǎn)錄病毒檢測--逆轉(zhuǎn)錄酶活性測定法 |
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4.5.2 |
逆轉(zhuǎn)錄病毒檢測--透射電鏡觀察法 |
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4.5.3 |
逆轉(zhuǎn)錄病毒檢測--感染性試驗(yàn) |
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4.5.4 |
逆轉(zhuǎn)錄病毒樣顆粒定量--透射電鏡法 |
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4.5.5 |
逆轉(zhuǎn)錄病毒樣顆粒定量--Q-PCR法 |
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4.6.1 |
鼠源性病毒檢測--細(xì)胞試驗(yàn) |
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4.6.2 |
鼠源性病毒檢測--動物抗體產(chǎn)生試驗(yàn) |
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4.6.3 |
鼠源性病毒檢測--雞胚感染試驗(yàn) |
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4.6.4 |
鼠源性病毒檢測--Q-PCR法 |
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4.7.1 |
人源病毒檢測--免疫熒光法 |
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4.7.2 |
人源病毒檢測--Q-PCR法 |
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4.8.1 |
牛源性病毒檢測--細(xì)胞培養(yǎng)法 |
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4.8.2 |
牛源性病毒檢測--熒光抗體檢測法 |
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4.8.3 |
牛源性病毒檢測--Q-PCR法 |
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4.9.1 |
鼠細(xì)小病毒檢測--細(xì)胞培養(yǎng)法 |
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4.9.2 |
鼠細(xì)小病毒檢測--Q-PCR法 |
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4.10.1 |
豬源性病毒檢測--細(xì)胞培養(yǎng)法 |
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4.10.2 |
豬源性病毒檢測--熒光抗體檢測法 |
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4.10.3 |
豬源性病毒檢測--Q- PCR法 |
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4.11.1 |
杯狀病毒（Vesivirus 2117）檢測--Q- PCR法 |
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5 |
成瘤性檢查 |
5.1 |
動物體內(nèi)接種法 |
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5.2 |
軟瓊脂克隆形成試驗(yàn) |
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5.3 |
端粒酶活性檢測--Q-PCR法 |
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6 |
致瘤性檢查 |
6.1 |
動物體內(nèi)接種法 |
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7 |
免疫學(xué)反應(yīng)檢測 |
7.1 |
淋巴細(xì)胞增殖抑制試驗(yàn) |
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7.2 |
特定淋巴細(xì)胞亞群檢測法（Th1,Th17,Treg） |
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7.3 |
淋巴細(xì)胞分泌TNF-α抑制試驗(yàn) |
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8 |
生物學(xué)有效性評價 |
8.1 |
成骨細(xì)胞分化試驗(yàn) |
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8.2 |
成軟骨細(xì)胞分化試驗(yàn) |
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8.3 |
成脂細(xì)胞分化試驗(yàn) |
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9 |
細(xì)胞活性檢測 |
9.1 |
細(xì)胞計(jì)數(shù)和細(xì)胞存活率檢測法 |
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9.2 |
細(xì)胞生長曲線測定法 |
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9.3 |
細(xì)胞周期測定--PI染色法 |
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10 |
殘留物檢測 |
10.1 |
牛血清白蛋白殘留檢測法 |
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10.2 |
抗生素殘留檢測--培養(yǎng)法 |
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10.3 |
抗生素殘留檢測--酶聯(lián)免疫法 |
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10.4 |
磁珠殘留 |
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10.5 |
Human IL-2殘留 |
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11 |
噬菌體污染檢查 |
11.1 |
透射電鏡觀察--負(fù)染色法 |
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11.2 |
培養(yǎng)觀察--噬斑法 |
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12 |
菌種鑒定 |
12.1 |
菌株染色觀察--普通染色法 |
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12.2 |
菌株染色觀察--革蘭氏染色法 |
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12.3 |
菌落形態(tài)觀察-培養(yǎng)法 |
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12.4 |
菌株抗生素抗性試驗(yàn)-培養(yǎng)法 |
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12.5 |
菌株生化特征分析--生化反應(yīng)試驗(yàn) |
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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 |
細(xì)菌內(nèi)毒素檢測 |
13.1 |
凝膠法 |
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14 |
可復(fù)制型病毒檢測 |
14.1 |
復(fù)制性逆轉(zhuǎn)錄病毒檢測--細(xì)胞培養(yǎng)和 Q- PCR法 |
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14.2 |
復(fù)制性慢病毒檢測--細(xì)胞培養(yǎng)和 Q- PCR/ELISA法 |
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15 |
細(xì)胞制劑檢測 |
CAR+T細(xì)胞比例 CD3+細(xì)胞比例 生物學(xué)活性 磁珠殘留 Human IL-2殘留 NK細(xì)胞自然殺傷活性檢測 NK細(xì)胞ADCC功能檢測 NK激活性和抑制性受體檢測GzmB,perforin,CD107表達(dá)水平檢測 |
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16 |
其他檢測項(xiàng)目 |
流式細(xì)胞術(shù)的絕對細(xì)胞計(jì)數(shù)方法 CCK-8法則定細(xì)胞群體倍增時間 細(xì)胞克隆形成率檢測方法 MSC急性毒性及抗GVHD效果評價 基于RPA-cas技術(shù)的口腔支原體檢測 基于LAMP技術(shù)的肺炎支原體的可視化檢測 Lb-cas12a蛋白的原核表達(dá)及純化 基于CRISPRCas系統(tǒng)的多種支原體核酸檢測 mRNA含量ribogreen熒光檢測 mRNA疫苗總抗體滴度ELISA檢測法 mRNA疫苗中和抗體效價假病毒中和試驗(yàn)檢測法 dsRNA雜質(zhì)ELISA檢測法 馬源性病毒檢查（3種） 禽源性病毒檢查（3種） 昆蟲細(xì)胞CO1條形碼分析法 昆蟲細(xì)胞螺原體qPCR檢測 昆蟲桿狀病毒檢測 昆蟲黃病毒檢測 昆蟲諾達(dá)病毒檢測 昆蟲彈狀病毒（內(nèi)源性/外源性）檢測 SV40大T抗原核酸序列檢測 腺病毒5型EIA基因檢測 胎畸瘤形成試驗(yàn) |
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