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Quality control and Nonclinical Research on CAR-T Cell Products: General Principles and Key Issues

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Engineering 2019年第1期5卷 122-131页

作者： Yonghong Li Yan Huo Lei Yu Junzhi Wang national institutes for food and drug control Beijing 100050 China

Adoptive cell therapy using chimeric antigen receptor T (CAR-T) cells, which is a promising cancer immunotherapy strategy, has been developing very rapidly in recent years. CAR-T cells are genetically modified T cells that can specifically recognize tumor specific antigens on the surface of tumor cells, and then effectively kill tumor cells. At present, exciting results are being achieved in clinical applications of CAR-T cells for patients with hematological malignancies. The research and development of CAR-T cells for various targets and for the treatment of solid tumors have become a hot topic worldwide, so an increasing number of investigational new drug applications (INDAs) and new drug applications (NDAs) of CAR-T cell products are expected to be submitted in future. The quality control and nonclinical research of these products are of great significance in ensuring the safety and effectiveness of these products;however, they also present great challenges and difficulties. This article discusses the general principles of and key issues regarding the quality control and nonclinical research of CAR-T cell products based on their product characteristics and on relevant guidelines for gene and cell therapy products.

关键词： Chimeric antigen receptor T cells Quality control Nonclinical research Safety Efficacy Clinical trials Cancer immunotherapy

Detection of illegally added drugs in dietary supplements by near-infrared spectral imaging

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Journal of Innovative Optical Health Sciences 2014年第6期7卷 90-96页

作者： Rui Zhang Lihui Yin Shaohong Jin national institutes for food and drug control beijing 100050 P.R.China

The application to detect ilally added drugs in dietary supplerments by near-infrared spectral imaging was studied with the focus on nifedipine,diclofenac and *** method is based on near-infrared spectral images correlation cofficient to detect ilally added *** results comply 100%with HPLC methods test results with no false positive results.

关键词： Near infrared spectral imaging ilgally added dietary supplements

Characterization of impurities in cefpodoxime proxetil using LC–MS^(n)

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Acta Pharmaceutica Sinica B 2014年第4期4卷 322-332页

作者： Jin Li Dousheng Zhang Changqin Hu national institutes for food and drug control Beijing 100050China

Reversed-phase liquid chromatography coupled with electrospray ionization tandem mass spectrometry(ESI-MS/MS)was used to characterize impurities in cefpodoxime proxetil,an ester-modified *** on the mechanisms by which cephalosporins are degraded,stress tests were designed and *** bulk material and capsule were eluted through a C18 column with formic acid–methanol–water as the mobile *** total,15 impurities were characterized in commercial samples,including 7 known impurities and 8 new *** structures of these unknown compounds were deduced via comparison with the fragmentation patterns of cefpodoxime *** from this systematic study will help improve the safety and quality of cefpodoxime proxetil.

关键词： Cefpodoxime proxetil Cephalosporins Impurities LC–MS Structure identification

COVID-19 vaccines: progress and understanding on quality control and evaluation

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Signal Transduction and Targeted Therapy 2021年第6期6卷 1646-1652页

作者： Qunying Mao Miao Xu Qian He Changgui Li Shufang Meng Yiping Wang Bopei Cui Zhenglun Liang Junzhi Wang national institutes for food and drug control BeijingChina

The outbreak of COVID-19 has posed a huge threat to global health and *** have revolutionized norms for working,socializing,learning,and ***,vaccines have been considered as most effective tools to combat with *** of the beginning of 2021,>200 COVID-19 vaccine candidates,covering nearly all existing technologies and platforms,are being research and development(R&D)by multiple manufacturers *** has posed a huge obstacle to the quality control and evaluation of those candidate vaccines,especially in China,where five vaccine platforms are deployed in *** accelerate the R&D progress of COVID-19 vaccines,the guidances on R&D of COVID-19 vaccine have been issued by national Regulatory Authorities or organizations *** Center for drug Evaluation and national quality control laboratory in China have played a leading role in launching the research on quality control and evaluation in collaboration with relevant laboratories involved in the vaccine R&D,which greatly supported the progression of vaccines R&D,and accelerated the approval for emergency use and conditional marketing of currently vaccine *** this paper,the progress and experience gained in quality control and evaluation of COVID-19 vaccines developed in China are summarized,which might provide references for the R&D of current and next generation of COVID-19 vaccines worldwide.

关键词： approval gained travel

A rapid reporter assay for recombinant human brain natriuretic peptide(rhBNP)by GloSensor technology

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Journal of Pharmaceutical Analysis 2018年第5期8卷 297-301页

作者： Lei Yu Xinchang Shi Chunmei Han Chunming Rao Junzhi Wang national institutes for food and drug control Beijing 100050China WHO CoUahoration Centre for Biologicals Standardization and Evaluation Beijing 100050China

Accurate determination of biological activity is essential in quality control of recombinant human brain natriuretic peptide （rhBNP）. In previous study, we successfully developed a genetically modified cell line 293GCAC3-based ELISA assay for rhBNP. But ELISA procedure is still tedious, so this study was aimed to develop a rapid and simple bioassay for rhBNP using GloSensor technology, which provides a platform of flexible luciferase-based biosensors for real-time detection of signaling events in live cells, including cGMP production. A reporter cell line 293GCAGIo-G1 was constructed by transfecting pGloSensorTM 40 F plasmid into 293GCAC3. The reporter assay based on 293GCAGIo-G1 showed high precision with intraassay CV being 8.3% and inter-assay CV being 14.1%; high accuracy with 80%, 100% and 120% recovery rate being 99.2%, 102.4% and 99.0% respectively; and great linearity with R^2 of linear fitting equation being 0.99. Besides, no significant difference was found in test results of reporter assay and 293GCAC3-based ELISA assay （paired t test,p = 0.630）. All these results suggested that the reporter assay was a viable assay for biological determination of rhBNP.

关键词： RhBNP cGMP GloSensor technology Reporter assay

Deep belief network-based drug identification using near infrared spectroscopy

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Journal of Innovative Optical Health Sciences 2017年第2期10卷 1-10页

作者： Huihua Yang Baichao Hu Xipeng Pan Shengke Yan Yanchun Feng Xuebo Zhang Lihui Yin Changqin Hu College of Electronic Engineering and Automation Guilin University of Electronic Technology 1 Jinji road Guilin 541004P.R.China A utomation School beijing University of Posts 8 Telecommunications 10 Xitucheng road Beijing 100876P.R.China national institutes for food and drug control 10 tiantanxili road Beijing 100050P.R.China

Near infrared spectroscopy(NIRS)analysis technology,combined with chemometrics,can be effectively used in quick and nondestructive analysis of quality and *** this paper,an effective drug identification method by using deep belief network(DBN)with dropout mecha-nism(dropout-DBN)to model NIRS is introduced,in which dropout is employed to overcome the overfitting problem coming from the small *** paper tests proposed method under datasets of different sizes with the example of near infrared diffuse refectance spectroscopy of erythromycin ethylsuccinate drugs and other drugs,aluminum and nonaluminum ***,it gives experiments to compare the proposed method's performance with back propagation(BP)neural network,support vector machines(SVMs)and sparse denoising auto-encoder(SDAE).The results show that for both binary classification and multi-classification,dropout mechanism can improve the classification accuracy,and dropout-DBN can achieve best classification accuracy in almost all *** is similar to dropout-DBN in the aspects of classification accuracy and algorithm stability,which are higher than that of BP neural network and SVM *** terms of training time,dropout-DBN model is superior to SDAE model,but inferior to BP neural network and SVM ***,dropout-DBN can be used as a modeling tool with effective binary and multi-class classification performance on a spectrum sample set of small size.

关键词： Deep belief networks near infrared spectroscopy drug classification dropout

Discussion on the dimerization reaction of penicillin antibiotics

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Journal of Pharmaceutical Analysis 2022年第3期12卷 481-488页

作者： Qizhang Wu Xia Zhang Jiaxin Du Changqin Hu national institutes for food and drug control Beijing102629China

Penicillins are one type of the most important antibiotics used in the *** of drug impurity profiles is an important part of ensuring drug *** is particularly important in penicillins where polymerization can lead to polymers as elicitors of passive cutaneous *** current understanding of penicillin polymerization is based on reactions with amino groups,but no comprehensive mechanistic understanding has been ***,we used theoretical calculations and column switching-LC/MS techniques to study penicillin *** and benzylpenicillin were selected as representative penicillins with or without amino groups in the side chain,*** identified four pathways by which this may occur and the energy barrier graphs of each reaction process were *** benzylpenicillin without an amino group in the 6-side chain,dimerization mode A is the dominant mode,where the 2-carboxyl group of one molecule reacts with the b-lactam of another ***,ampicillin with an amino group in the 6-side chain favors dimerization mode C,where the amino group of one molecule attacks the b-lactam of another *** findings can lead to a polymer control approach to maintaining penicillin antibiotics in an active formulation.

关键词： Penicillins Dimerization reaction Theoretical calculations LC/MS

Multi-manufacturer drug identification based on near infrared spectroscopy and deep transfer learning

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Journal of Innovative Optical Health Sciences 2020年第4期3卷 39-50页

作者： Lingqiao Li Xipeng Pan Wenli Chen Manman Wei Yanchun Feng Lihui Yin Changqin Hu Huihua Yang School of Automation beijing University of Posts and Telecommunications 10 Xitucheng road Beijing 100876P.R.China School of Computer Science and Information Security Guilin University of Electronic Technology 1 Jinji road Guilin 541004P.R.China national institutes for food and drug control 10 tiantanxili road beijing 100050 P.R.China

Near infrared(NIR)spectrum analysis technology has outstanding advantages such as rapid,nondestructive,pollution-free,and is widely used in food,pharmaceutical,petrochemical,agricultural products production and testing *** neural network(CNN)is one of the most successful methods in big data analysis because of its powerful feature ex-traction and abstraction ability,and it is especially suitable for solving multi-classification ***-based transfer learning is a machine learning technique,which migrates para-meters of trained model to the new one to improve the *** transfer learning strategy can speed up the learning efficiency of the model instead of learning from *** view of the difficulty in acquisition of drug NIR spectral data and high labeling cost,this paper proposes three simple but very effective transfer learning methods for multi-manufacturer identification of drugs based on one-dimensional *** with the original CNN,the transfer learning method can achieve better classification performance with fewer NIR spectral data,which greatly reduces the dependence on labeled NIR spectral *** the same time,this paper also compares and discusses three different transfer learning methods,and selects the most suitable transfer learning model for drug NIR spectral data *** with the current popular methods,such as SVM,BP,AE and ELM,the proposed method achieves higher classification accuracy and scalability in multi-variety and multi-manufacturer NIR spectrum classification experiments.

关键词： Near-infrared spectroscopy transfer learning drug identification multi-manufacturer

In vitro genotoxicity evaluation and metabolic study of residual glutaraldehyde in animal-derived biomaterials

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Regenerative Biomaterials 2020年第6期7卷 619-625页

作者： Jianfeng Shi Huan Lian Yuanli Huang Danmei Zhao Han Wang Chunren Wang Jingli Li Linnan Ke Institute for Medical Devices control National Institutes for Food and Drug ControlNo.31 Huatuo RoadBeijing 102629China

Glutaraldehyde(GA)is an important additive that is mainly used in animal-derived biomaterials to improve their mechanical and antimicrobial ***,GA chemical toxicity and the metabolic mechanism remain relatively ***,residual GA has always been a major health risk consideration for animal-derived medical *** this study,extracts of three biopatches were tested via the GA determination test and mouse lymphoma assay(MLA).The results showed that dissolved GA was a potential mutagen,which could induce significant cytotoxic and mutagenic effects in mouse lymphoma *** toxic reactions were relieved by the S9 metabolic activation(MA)***,we confirmed that GA concentration decreased and glutaric acid was generated during the catalytic *** revealed GA could be oxidized via cytochrome P450 which was the main metabolic factor of *** found that even though GA was possibly responsible for positive reactions of animal-derived biomaterials’biocompatibility evaluation,it may not represent the real situation occurring in human bodies,owing to the presence of various detoxification mechanisms including the S9 ***,in order to achieve a general balance between risk management and practical application,rational decisions based on comprehensive analyses must be considered.

关键词： glutaraldehyde cytochrome P450 biocompatibility evaluation of medical devices animal-derived biomaterials