Jiachang Biological - biotechnology services and research and development as one of the high-tech enterprises
High qualityefficienttransparent
High quality, efficient and transparent
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
|
序號 |
類(lei)別(產品/項目/參數) |
產品/項目/參數 |
依據的標準（方(fang)法(fa)）名稱(cheng)及編號（含年號） |
|
|
序(xu)號 |
名 稱 |
|||
|
1 |
細胞(bao)鑒別試驗 |
1.1 |
同工酶試驗 |
生(sheng)物制品生(sheng)產檢定(ding)用動(dong)物細胞(bao)基質制備及(ji)檢定(ding)規程《中國(guo)藥典(dian)》2020年版三部， 生(sheng)物(wu)制品(pin)(pin)生(sheng)產檢定用菌毒種管理(li)及質量控(kong)制、 生(sheng)物(wu)制品(pin)(pin)生(sheng)產檢定用動物(wu)細胞基質制備及質量控(kong)制、生(sheng)物(wu)制品(pin)(pin)病毒安全性控(kong)制《中國藥典(dian)》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 |
|
1.2 |
染色體核(he)型分析法 |
|||
|
1.3 |
STR分析(xi)法 |
|||
|
1.4 |
細胞形態觀察(cha)法(fa) |
|||
|
1.5 |
細胞表面標(biao)記物檢測--流式(shi)細胞術 |
|||
|
1.6 |
DNA條形碼法 |
|||
|
1.7 |
種屬鑒定-- PCR法 |
|||
|
1.8 |
RAPD法（隨(sui)機擴(kuo)增多態性DNA） |
|||
|
2 |
無菌檢(jian)查 |
2.1 |
細菌、真菌無菌檢查--薄膜過(guo)濾法 |
|
|
2.2 |
細(xi)菌(jun)、真菌(jun)無(wu)菌(jun)檢查--直(zhi)接接種法 |
|||
|
2.3 |
分枝桿(gan)菌檢查(cha)法 |
|||
|
3 |
支原體檢查 |
3.1 |
支原(yuan)體檢查--瓊脂培養法 |
|
|
3.2 |
支原體檢查--液體培養法 |
|||
|
3.3 |
支(zhi)原體檢查--DNA染色法 |
|||
|
4 |
內、外源(yuan)病(bing)毒因(yin)子檢查 |
4.1 |
細(xi)胞(bao)形態觀(guan)察及血吸附試驗(yan) |
|
|
4.2 |
體外(wai)不(bu)同指示細胞(bao)接種(zhong)培養(yang)法 |
|||
|
4.3 |
動物體內接(jie)種法 |
|||
|
4.3.1 |
乳(ru)鼠腦(nao)內及腹腔(qiang)接種法 |
|||
|
4.3.2 |
小(xiao)鼠腦內(nei)及(ji)腹腔接種法 |
|||
|
4.3.3 |
豚鼠腹腔接種法 |
|||
|
4.3.4 |
家兔皮內及皮下接種法 |
|||
|
4.4 |
雞(ji)胚接種法 |
|||
|
4.4.1 |
雞胚卵黃囊接種(zhong)法 |
|||
|
4.4.2 |
雞胚尿囊(nang)(nang)腔接種及尿囊(nang)(nang)液(ye)血凝試驗 |
|||
|
4.5.1 |
逆轉錄病毒檢(jian)測--逆轉錄酶(mei)活性測定法 |
|||
|
4.5.2 |
逆(ni)轉錄病毒檢測--透(tou)射電鏡觀察法(fa) |
|||
|
4.5.3 |
逆轉錄(lu)病毒(du)檢測(ce)--感染性試驗(yan) |
|||
|
4.5.4 |
逆轉錄病(bing)毒(du)樣顆粒定量--透射電鏡法 |
|||
|
4.5.5 |
逆轉錄病(bing)毒(du)樣顆粒(li)定量(liang)--Q-PCR法(fa) |
|||
|
4.6.1 |
鼠源性病(bing)毒檢測--細胞試(shi)驗 |
|||
|
4.6.2 |
鼠源性病毒檢測--動物抗體產生試驗 |
|||
|
4.6.3 |
鼠源(yuan)性病(bing)毒(du)檢測--雞胚(pei)感染試(shi)驗(yan) |
|||
|
4.6.4 |
鼠(shu)源性病毒檢測--Q-PCR法 |
|||
|
4.7.1 |
人(ren)源病毒檢測--免(mian)疫熒光法 |
|||
|
4.7.2 |
人源病(bing)毒(du)檢測(ce)--Q-PCR法 |
|||
|
4.8.1 |
牛源性病毒檢測--細胞培養法(fa) |
|||
|
4.8.2 |
牛(niu)源性病毒檢測--熒(ying)光抗(kang)體檢測法 |
|||
|
4.8.3 |
牛(niu)源(yuan)性病毒檢(jian)測--Q-PCR法 |
|||
|
4.9.1 |
鼠細小病毒檢測(ce)--細胞培養法(fa) |
|||
|
4.9.2 |
鼠(shu)細(xi)小病(bing)毒檢測--Q-PCR法 |
|||
|
4.10.1 |
豬源性病(bing)毒檢(jian)測--細胞培養法 |
|||
|
4.10.2 |
豬源性病(bing)毒檢測(ce)--熒光抗(kang)體檢測(ce)法(fa) |
|||
|
4.10.3 |
豬源性病毒檢測--Q- PCR法 |
|||
|
4.11.1 |
杯狀病毒（Vesivirus 2117）檢測(ce)--Q- PCR法 |
|||
|
5 |
成瘤性(xing)檢查(cha) |
5.1 |
動物體(ti)內接種法 |
|
|
5.2 |
軟(ruan)瓊(qiong)脂克隆(long)形成(cheng)試驗 |
|||
|
5.3 |
端粒酶活性檢測--Q-PCR法 |
|||
|
6 |
致瘤性(xing)檢(jian)查 |
6.1 |
動物(wu)體內接種法 |
|
|
7 |
免疫學反應檢(jian)測 |
7.1 |
淋巴(ba)細胞(bao)增(zeng)殖(zhi)抑制試驗 |
|
|
7.2 |
特定淋巴細胞亞群檢測法(fa)（Th1,Th17,Treg） |
|||
|
7.3 |
淋(lin)巴細胞分泌TNF-α抑(yi)制試驗 |
|||
|
8 |
生物學有(you)效性評價 |
8.1 |
成骨細胞分(fen)化試驗 |
|
|
8.2 |
成軟骨細胞(bao)分(fen)化試驗 |
|||
|
8.3 |
成脂細胞分化試驗 |
|||
|
9 |
細胞活性檢測 |
9.1 |
細(xi)胞計(ji)數(shu)和細(xi)胞存活率檢測法 |
|
|
9.2 |
細胞生(sheng)長曲線測定法 |
|||
|
9.3 |
細胞(bao)周期測定--PI染色法 |
|||
|
10 |
殘留物檢測 |
10.1 |
牛(niu)血清白(bai)蛋白(bai)殘留(liu)檢測(ce)法 |
|
|
10.2 |
抗生(sheng)素殘留檢測--培養法 |
|||
|
10.3 |
抗生素殘留(liu)檢(jian)測--酶聯免疫法 |
|||
|
10.4 |
磁(ci)珠殘(can)留 |
|||
|
10.5 |
Human IL-2殘留 |
|||
|
11 |
噬菌體污(wu)染(ran)檢查 |
11.1 |
透射電鏡觀察(cha)--負(fu)染色(se)法 |
|
|
11.2 |
培養觀察--噬斑法 |
|||
|
12 |
菌種鑒定 |
12.1 |
菌株染色觀察--普(pu)通(tong)染色法 |
|
|
12.2 |
菌(jun)株染(ran)色觀察--革蘭氏染(ran)色法 |
|||
|
12.3 |
菌落形態觀察-培養法 |
|||
|
12.4 |
菌株(zhu)抗(kang)生素抗(kang)性試驗-培養法 |
|||
|
12.5 |
菌株生化(hua)(hua)特征分析--生化(hua)(hua)反應試驗 |
|||
|
12.6 |
16SrRNA分析法 |
|||
|
12.7 |
18SrRNA分析法 |
|||
|
12.8 |
26SrRNA分析法 |
|||
|
12.9 |
ITS序列分析法 |
|||
|
13 |
細菌內毒素(su)檢測 |
13.1 |
凝膠法 |
|
|
14 |
可(ke)復制型病毒(du)檢測 |
14.1 |
復制性逆轉錄病毒檢測(ce)--細胞培養(yang)和 Q- PCR法 |
|
|
14.2 |
復制性慢病(bing)毒(du)檢測--細(xi)胞培養和 Q- PCR/ELISA法 |
|||
|
15 |
細胞(bao)制劑檢測(ce) |
CAR+T細胞比例 CD3+細胞比例 生物學(xue)活性 磁珠殘留(liu) Human IL-2殘(can)留 NK細胞自然殺傷(shang)活性檢測 NK細胞ADCC功能(neng)檢測 NK激(ji)活性和抑制性受體檢測GzmB,perforin,CD107表達水平檢測 |
|
|
|
16 |
其他檢測(ce)項目 |
流式(shi)細胞術(shu)的絕對細胞計數方法 CCK-8法(fa)則(ze)定細(xi)胞群體倍增時間 細胞克隆形成率檢測方法 MSC急性毒(du)性及抗GVHD效果評價 基于RPA-cas技術的口腔支原體檢測 基于LAMP技術的肺(fei)炎支原體的可視化檢測(ce) Lb-cas12a蛋白的(de)原(yuan)核(he)表達及純化 基于CRISPRCas系統的多(duo)種支原體核(he)酸(suan)檢測 mRNA含量(liang)ribogreen熒光(guang)檢測 mRNA疫(yi)苗總抗體滴度ELISA檢測法 mRNA疫苗中(zhong)和抗體效價假病毒中(zhong)和試驗檢測法 dsRNA雜(za)質ELISA檢測法 馬源性(xing)病毒檢查(cha)（3種） 禽(qin)源性病毒檢查（3種） 昆蟲細胞(bao)CO1條形碼分(fen)析(xi)法(fa) 昆(kun)蟲細胞螺原體(ti)qPCR檢(jian)測 昆蟲桿狀(zhuang)病毒檢測 昆(kun)蟲黃病毒檢測 昆蟲(chong)諾(nuo)達病(bing)毒檢測 昆蟲彈(dan)狀病毒(du)（內源性/外源性）檢測 SV40大T抗原核酸序列檢測 腺(xian)病毒(du)5型(xing)EIA基因檢測 胎畸瘤形成試驗(yan) |
||
