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Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics

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Journal of pharmaceutical Analysis 2024年第6期14卷 785-804页

作者： Patanachai K.Limpikirati Sorrayut Mongkoltipparat Thinnaphat Denchaipradit Nathathai Siwasophonpong Wudthipong Pornnopparat Parawan Ramanandana Phumrapee Pianpaktr Songsak Tongchusak Maoxin Tim Tian Trairak Pisitkun Department of Food and pharmaceutical Chemistry Faculty of Pharmaceutical SciencesChulalongkorn UniversityPathumwanBangkok10330Thailand pharmaceutical sciences and Technology(PST)Graduate program Faculty of Pharmaceutical SciencesChulalongkorn UniversityPathumwanBangkok10330Thailand Center of Excellence in Systems Biology(CUSB) Faculty of MedicineChulalongkorn UniversityPathumwanBangkok10330Thailand Department of pharmaceutical Chemistry Faculty of Pharmaceutical SciencesHuachiew Chalermprakiet UniversityBang PhliSamut Prakan10540Thailand Division of Research Affairs Faculty of MedicineChulalongkorn UniversityPathumwanBangkok10330Thailand

In this review,we focus on providing basics and examples for each component of the protein therapeutic specifications to interested pharmacists and biopharmaceutical scientists with a goal to strengthen understanding in regulatory science and *** specifications comprise a list of important quality attributes for testing,references to use for test procedures,and appropriate acceptance criteria for the tests,and they are set up to ensure that when a drug product is administered to a patient,its intended therapeutic benefits and safety can be rendered *** of drug substance or drug product to the specifications is achieved by testing an article according to the listed tests and analytical methods and obtaining test results that meet the acceptance *** attributes are chosen to be tested based on their quality risk,and consideration should be given to the merit of the analytical methods which are associated with the acceptance criteria of the *** criteria are set forth primarily based on efficacy and safety profiles,with an increasing attention noted for patient-centric *** in this work are related guidelines that support the biopharmaceutical specification setting,how to set the acceptance criteria,and examples of the quality attributes and the analytical methods from 60 articles and 23 pharmacopeial *** are also explored on process analytical technologies and other orthogonal tools which are on-trend in biopharmaceutical characterization and quality control.

关键词： Biopharmaceutical analysis Biopharmaceutical quality control Biopharmaceutical specifications Monoclonal antibodies Protein therapeutics Regulatory science

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Comprehensive review on ethnomedicinal, phytochemistry and pharmacological profile of Ficus Religiosa L.

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Journal of Traditional Chinese Medicine 2024年第5期44卷 1052-1057页

作者： Rahul Rawat Harish Kumar Neetu Singh Aakash Deep Balasubramanian Narasimhan Surender Singh Yadav Sanjiv Kumar Department of pharmaceutical sciences Chaudhary Bansi Lal University Department of Botany Maharshi Dayanand University Faculty of pharmaceutical sciences Maharshi Dayanand University

Ficus religiosa L.(F. religiosa) or sacred fig is a large perennial tree belonging to the family Moraceae or mulberry family. Though the tree has pan-tropical distribution but originally it is indigenous to the Indian subcontinent and Indochina region. Popularly the tree is named "Pepal or bodhi tree". Traditionally, it is practiced for the treatment of asthma, nose bleeding, heart disorders, diabetes, wound healing, ear problems, constipation, hyperlipidemia, gonorrhea, ulcers and infectious disorders. Chemical analysis demonstrated the presence of numerous bioactives including tannins, phenols, saponins, sugars, alkaloids, methionine, terpenoids, flavonoids, glycosides, proteins, separated amino acids, essential and volatile oils and steroids etc., which are probably responsible for its diverse pharmacological actions. The present work is an attempt to compile up-to-date comprehensive information on F. religiosa that covers its taxonomy, ethnomedicinal importance, phytochemistry, pharmacological attributes and clinical trials. Keeping in mind the various health attributes of F. religiosa, future research can be aimed at in-depth elucidation of the structure-function relationship and multifactorial signalings pathways.

关键词： Ficus religiosa clinical trials ethnomedicine health benefits pharmacology phytoconstituents

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Oral delivery of ferroptosis inducers for effective treatment of hepatic fibrosis

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Nano Research 2024年第8期17卷 7621-7630页

作者： Yinglan Yu Shunlong Zhang Yongfeng Xu Hao Shao Lei Luo College of pharmaceutical sciences Southwest UniversityChongqing 400715China

Liver fibrosis is characterized by the excessive accumulation of extracellular matrix(ECM),which is primarily produced by activated hepatic stellate cells(HSCs).However,effective therapies for hepatic fibrosis are currently *** is a promising anti-fibrotic drug candidate,but its clinical application is hindered by limited ***,we present a novel oral delivery platform that enhances the HSCs uptake of artesunate and induces potent *** platform is vitamin Adecorated nanoparticles encapsulated with *** multifunctional ligand vitamin A interacts with retinol-binding proteins that are highly expressed on the intestinal epithelium to promote transcytosis,highly expressed on the surface of HSCs but lowly expressed in normal *** oral administration,this oral delivery platform enhances transepithelial transport in the intestine,improves drug accumulation in the liver,and continuously increases HSCs uptake of *** drug release in HSCs,artesunate depletes glutathione peroxidase 4 and glutathione,effectively initiating *** vivo experiments demonstrate that this strategy induces pronounced ferroptosis,efficiently relieving liver *** work provides a proof-ofconcept demonstration that an oral delivery strategy for ferroptosis inducers may be beneficial for liver fibrosis treatment.

关键词： liver fibrosis hepatic stellate cells oral delivery intestinal epithelium ferroptosis

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Caffeic acid 3,4-dihydroxyphenethyl ester prevents colorectal cancer through inhibition of multiple cancer-promoting signal pathways in 1,2-Dimethylhydrazine/dextran sodium sulphate mouse model

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Journal of Traditional Chinese Medicine 2024年第1期44卷 70-77页

作者： JIN Tao ZHOU Qian SHEN Jichen ZHANG Zhizhong LIAN Xiaoyuan College of pharmaceutical sciences Zhejiang UniversityHangzhou 310058China pharmaceutical Informatics Institute College of Pharmaceutical SciencesZhejiang UniversityHangzhou 310058China Ocean College Zhoushan Campus of Zhejiang UniversityZhoushan 316021China

OBJECTIVE:To elucidate the potential feature and mechanism of the caffeic acid 3,4-dihydroxyphenethyl ester(CADPE)molecule,which can prevent colorectal cancer(CRC)in the 1,2-Dimethylhydrazine(DMH)/dextran sodium sulphate(DSS)-induced mouse ***:Institute of cancer research(ICR)male mice were injected with 20 mg/kg DMH for a *** that,2%DSS was administered in the drinking water for another 7 *** CADPE treatment was given to the DMH/DSS induced male mice at three different periods until their *** examination was used for observing the CRC development at colonic ***(IHC),blood cells smearing and crypt damage scoring methods were used for investigating the anti-inflammation feature of CADPE related to *** reversing targets searching method was applied with artificial intelligence(AI),computeraided drug designing(CADD)and Ingenuity Pathway Analysis(IPA)techniques for predicting the potential targets and mechanism of CADPE highly related to ***:The data indicated that CADPE inhibited CRC tumor development in the colitis-associated DMH/DSS induced mouse model after giving the early *** also impeded the acute inflammation by decreasing the infiltration of neutrophils significantly during the initial stage of CRC ***,our data showed that CADPE prevented CRC by blocking active sites of three pivotal protein targets including epidermal growth factor receptor(EGFR),extracellular signal-regulated kinase(ERK)and mammalian target of rapamycin(m TOR)in two major cancer development ***:CADPE effectively prevented CRC at early stage of tumor germination in the DMH/DSS mouse model highly likely due to its anti-acute inflammation characteristic and the ability of blocking EGFR,ERK and m TOR activities in two highly related CRC developing pathways.

关键词： caffeic acids colorectal neoplasms inflammation chemoprevention Sarcandra glabra

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Pharmacological potential of Manilkara zapota(L.)***(Sapodilla):a narrative review

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Journal of Traditional Chinese Medicine 2024年第2期44卷 403-407页

作者： Priyanka Sharma Aakash Deep Harish Kumar Nitin Bansal Sanjiv Kumar Arun Davinder Kumar Department of pharmaceutical sciences Chaudhary Bansi Lal UniversityBhiwani 127021India Department of pharmaceutical sciences Maharishi Dayanand UniversityRohtak 124001India

Herbal medicine is safe and effective in treating various *** herbal medicine plays a tremendous role in treatment of various diseases and accompanying complications,hence herbal medicine requires remarkable attention in further research for the development of numerous active formulations for treatment of health *** plant needs special consideration for development and research of unidentified compound and characterization of novel active molecules that overcome multiple pathological *** genus Manilkara contains 135 plants around the *** overview discusses all the virtues of most important and commonly used plant Manilkara zapota(L.)***(***),also known as *** has various traditional beneficial effects in treatment of various diseases and disorders dating back to prehistoric times and used in ancient traditional system of herbal medicine.

关键词： herbal medicine Manilkara zapota phytoconstituents pharmacological activity review

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Real-time model correction using Kalman filter for Raman-controlled cell culture processes

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Chinese Journal of Chemical Engineering 2024年第6期70卷 251-260页

作者： Xiaoxiao Dong Zhuohong He Xu Yan Dong Gao Jingyu Jiao Yan Sun Haibin Wang Haibin Qu pharmaceutical Informatics Institute College of Pharmaceutical SciencesZhejiang UniversityHangzhou 310058China Hisun Biopharmaceutical Co.Ltd. Hangzhou 311404China

Raman spectroscopy has found extensive use in monitoring and controlling cell culture *** this context,the prediction accuracy of Raman-based models is of paramount ***,models established with data from manually fed-batch cultures often exhibit poor performance in Raman-controlled ***,there is a need for effective methods to rectify these *** objective of this paper is to investigate the efficacy of Kalman filter(KF)algorithm in correcting Raman-based models during cell ***,partial least squares(PLS)models for different components were constructed using data from manually fed-batch cultures,and the predictive performance of these models was ***,various correction methods including the PLS-KF-KF method proposed in this study were employed to refine the PLS ***,a case study involving the auto-control of glucose concentration demonstrated the application of optimal model correction *** results indicated that the original PLS models exhibited differential performance between manually fed-batch cultures and Raman-controlled *** glucose,the root mean square error of prediction(RMSEP)of manually fed-batch culture and Raman-controlled culture was 0.23 and 0.40 g·L^(-1).With the implementation of model correction methods,there was a significant improvement in model performance within Raman-controlled *** RMSEP for glucose from updating-PLS,KF-PLS,and PLS-KF-KF was 0.38,0.36 and 0.17 g·L^(-1),***,the proposed PLS-KF-KF model correction method was found to be more effective and stable,playing a vital role in the automated nutrient feeding of cell cultures.

关键词： Raman spectroscopy Model correction Algorithm Model-predictive control Bioprocess

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The Contributions of Thrombospondin-1 to Epilepsy Formation

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Neuroscience Bulletin 2024年第5期40卷 658-672页

作者： Yao Cheng Yujie Zhai Yi Yuan Qiaoyun Wang Shucui Li Hongliu Sun School of pharmaceutical sciences Binzhou Medical UniversityYantai264003China

Epilepsy is a neural network disorder caused by uncontrolled neuronal hyperexcitability induced by an imbalance between excitatory and inhibitory *** synaptogenesis plays a vital role in the formation of overexcited *** evidence has confirmed that thrombospondin-1(TSP-1),mainly secreted by astrocytes,is a critical cytokine that regulates synaptogenesis during ***,numerous studies have reported that TSP-1 is also involved in other processes,such as angiogenesis,neuroinflammation,and regulation of Ca^(2+)homeostasis,which are closely associated with the occurrence and development of *** this review,we summarize the potential contributions of TSP-1 to epilepsy development.

关键词： Thrombospondin-1 Epileptogenesis Synaptogenesis Hyperexcitability

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Genome mining of multi-substituted alkylresorcinols from a hybrid highly reducing-and typeⅢ-polyketide pathway

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Chinese Chemical Letters 2024年第7期35卷 345-349页

作者： Huaran Zhang Yuting Huang Yingjie Tang Dekun Kong Yi Zou College of pharmaceutical sciences Southwest UniversityChongqing 400715China

Fungal alkylresorcinols are a class of polyketides,which are commonly synthesized by the hybridization of highly reducing polyketide synthase(hrPKS)with non-reducing polyketide synthase(nrPKS).In this study,we identified and demonstrated a new assembly model for synthesizing alkylresorcinol(scirpilin A,1),which was accomplished by collaboration of a hrPKS(FscA)and a typeⅢPKS(FscB).Furthermore,three post-tailoring enzymes(FscC,FscD,and FscE)act iteratively on 1 skeleton,including successive 14e-oxidation of inert carbons,di-halogenation,and di-methylation,to form highly oxidized and multisubstituted *** work presents an unusual synthesis manner of alkylresorcinols,sheds light on the collaborative mechanism between hrPKS and typeⅢPKS and provides three valuable enzymatic catalysts for the tailoring of alkylresorcinol family natural products in future.

关键词： Genome mining Alkylresorcinol hrPKS TypeⅢPKS Iterative catalysis

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Enantioselective iridium-catalyzed allylic substitution with a Reformatsky reagent: direct construction of β-stereogenic homoallylic esters

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Science China Chemistry 2024年第11期67卷 3791-3797页

作者： Debasis Pal Kirana D.Veeranna Yuk Fai Wong P.Andrew Evans Department of Chemistry Queen's University Xiangya School of pharmaceutical sciences Central South University

The Reformatsky reagent derived from ethyl bromoacetate circumvents the challenge associated with the direct regio-and enantioselective iridium-catalyzed allylic alkylation with an unstabilized aliphatic ester enolate. Notably, this work represents the first example of using a Reformatsky reagent in a metal-allyl reaction, which permits the direct construction of enantioenriched β-stereogenic homoallylic esters without preactivation of the pronucleophile or post-reaction modification of the product(e.g., thermal decarboxylation of a 1,3-dicarbonyl). Moreover, the process allows the coupling of a broad range of sterically and electronically diverse electrophiles bearing aryl, heteroaryl and alkenyl derivatives, including the significantly more challenging alkyl-substituted allylic carbonates. The versatility of the ester product is exemplified by a series of functional group manipulations and the development of a concise and efficient enantioselective total synthesis of the natural product,(+)-descurainolide A. Finally, mechanistic studies indicate that the zinc enolate behaves as a soft nucleophile that undergoes outer-sphere alkylation.

关键词： allylic substitution asymmetric catalysis mechanistic studies natural product synthesis Reformatsky reagent

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Complications and comorbidities associated with antineoplastic chemotherapy:Rethinking drug design and delivery for anticancer therapy

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Acta Pharmaceutica Sinica B 2024年第7期14卷 2901-2926页

作者： Xiaoman Mao Shuang Wu Dandan Huang Chong Li College of pharmaceutical sciences Southwest UniversityChongqing 400715China Medical Research Institute Southwest UniversityChongqing 400715China School of pharmaceutical sciences Southern Medical UniversityGuangzhou 510515China

Despite the considerable advancements in chemotherapy as a cornerstone modality in cancer treatment,the prevalence of complications and pre-existing diseases is on the rise among cancer patients along with prolonged survival and aging *** relationships between these disorders and cancer are intricate,bearing significant influence on the survival and quality of life of individuals with cancer and presenting challenges for the prognosis and outcomes of ***,we review the prevailing complications and comorbidities that often accompany chemotherapy and summarize the lessons to learn from inadequate research and management of this scenario,with an emphasis on possible strategies for reducing potential complications and alleviating comorbidities,as well as an overview of current preclinical cancer models and practical advice for establishing bio-faithful preclinical models in such complex context.

关键词： Complications Comorbidities Chemotherapy Preclinical cancer models Drug design Drug delivery

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