{"title":"Meet our Editorial Board Member: Dr. Andreas Tsakalof","authors":"A. Tsakalof","doi":"10.17145/jab.18.013","DOIUrl":"https://doi.org/10.17145/jab.18.013","url":null,"abstract":"","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87082942","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mendy Ter Avest, Anette Veringa, K. van Hateren, R. Koster, D. Touw, J. Alffenaar
{"title":"Method for Therapeutic Drug Monitoring of Voriconazole and its Primary Metabolite Voriconazole-N-oxide in Human Serum using LC-MS/MS","authors":"Mendy Ter Avest, Anette Veringa, K. van Hateren, R. Koster, D. Touw, J. Alffenaar","doi":"10.17145/jab.18.016","DOIUrl":"https://doi.org/10.17145/jab.18.016","url":null,"abstract":"","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81501665","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
a gorgeous font of chemical compounds for drug discovery. Advances in genome sequencing and mining, in addition to bio-synthetic pathway manipulation, allow the expression of silent (cryptic) gene clusters and provide the access to previously underexplored sources such as new groups of microorganisms, consequently highlighting that is possible to discover new chemical entities. A fundamental role is played by the progress in compound detection technologies. Indeed, the main intent is to shorten the time necessary to discard known compounds and identify the new ones. High resolution mass spectrometry (HRMS) has become a reliable detection responding to several analytical challenges. Actually, the employment of Mass Spectrometry has grown up like a giant tree developing many branches and a thick crown that invaded almost all research fields regarding the omics sciences (metabolomics, proteomics, lipidomics, etc.) [1]. Hence, an extraordinary time started to strongly stimulate analytical data acquisition; it became possible to directly analyze crude extracts without the need for purification/ isolation of specific species and large data sets can be processed at once [2]. Several experimental databases, such as Dictionary of Natural Products DNP, ChemSpider, REAXYS, and several software tools such as METLIN, MIDAS and MetFRAg [3] can be used for metabolite identification in metabolomics; molecular structures were provided and matching of measured mass spectra (MS/MS) against the predicted fragments of metabolites can be performed although very often the signals found do not correspond with the described ones [4]. MS based metabolomics became the technique of choice for rapid detection and dereplication of secondary metabolites, not only in natural product microbial cultures. Clear indications for performing this study are available [5] but software tailored to predict all the metabolites modifications have not yet been fully developed, established that not only enzymatic transformations but also exogenous compounds from different environmental factors can contribute to production of new metabolites. We would like to comment some of advantages and challenges of HRMS and its future potential leading to interesting structural information that can direct the an1Fondazione Istituto Insubrico Ricerca per la Vita, 21040 Gerenzano (Va), Italy 2Istituto di Ricerche Chimiche e Biochimiche G. Ronzoni, 20133 Milan, Italy
一个华丽的化合物字体的药物发现。基因组测序和挖掘方面的进展，除了生物合成途径操作之外，还允许沉默(隐式)基因簇的表达，并提供了以前未充分探索的来源，例如新的微生物群，从而突出了发现新化学实体的可能性。化合物检测技术的进步起着根本性的作用。事实上，其主要目的是缩短丢弃已知化合物和识别新化合物所需的时间。高分辨率质谱(HRMS)已经成为一种可靠的检测方法，可以应对许多分析挑战。实际上，质谱技术的应用已经像一棵枝叶茂密的大树，几乎侵入了所有与组学相关的研究领域(代谢组学、蛋白质组学、脂质组学等)[1]。因此，一个不寻常的时间开始强烈刺激分析数据采集;直接分析粗提取物成为可能，而无需对特定物种进行纯化/分离，并且可以一次处理大量数据集[2]。几种实验数据库，如Dictionary of Natural Products DNP、ChemSpider、REAXYS等，以及METLIN、MIDAS、MetFRAg等软件工具[3]可用于代谢组学中的代谢物鉴定;提供分子结构，并将测量的质谱(MS/MS)与预测的代谢物片段进行匹配，尽管通常发现的信号与所描述的信号不一致[4]。基于质谱的代谢组学成为快速检测和分离次生代谢物的首选技术，而不仅仅是在天然产物微生物培养中。进行这项研究有明确的适应症[5]，但专门用于预测所有代谢物修饰的软件尚未完全开发，确定不仅酶转化，而且来自不同环境因素的外源化合物也可以促进新代谢物的产生。我们想评论一下HRMS的一些优势和挑战，以及它未来的潜力，从而产生有趣的结构信息，可以指导1 . fondazione instituto Insubrico Ricerca per la Vita, 21040 Gerenzano (Va)，意大利2 . instituto di Ricerche Chimiche Biochimiche G. Ronzoni, 20133米兰，意大利
{"title":"High Resolution-Mass Spectrometry as a unique Bioanalytical Tool in Natural Product Studies","authors":"L. Carrano, Elena Urso","doi":"10.17145/jab.18.014","DOIUrl":"https://doi.org/10.17145/jab.18.014","url":null,"abstract":"a gorgeous font of chemical compounds for drug discovery. Advances in genome sequencing and mining, in addition to bio-synthetic pathway manipulation, allow the expression of silent (cryptic) gene clusters and provide the access to previously underexplored sources such as new groups of microorganisms, consequently highlighting that is possible to discover new chemical entities. A fundamental role is played by the progress in compound detection technologies. Indeed, the main intent is to shorten the time necessary to discard known compounds and identify the new ones. High resolution mass spectrometry (HRMS) has become a reliable detection responding to several analytical challenges. Actually, the employment of Mass Spectrometry has grown up like a giant tree developing many branches and a thick crown that invaded almost all research fields regarding the omics sciences (metabolomics, proteomics, lipidomics, etc.) [1]. Hence, an extraordinary time started to strongly stimulate analytical data acquisition; it became possible to directly analyze crude extracts without the need for purification/ isolation of specific species and large data sets can be processed at once [2]. Several experimental databases, such as Dictionary of Natural Products DNP, ChemSpider, REAXYS, and several software tools such as METLIN, MIDAS and MetFRAg [3] can be used for metabolite identification in metabolomics; molecular structures were provided and matching of measured mass spectra (MS/MS) against the predicted fragments of metabolites can be performed although very often the signals found do not correspond with the described ones [4]. MS based metabolomics became the technique of choice for rapid detection and dereplication of secondary metabolites, not only in natural product microbial cultures. Clear indications for performing this study are available [5] but software tailored to predict all the metabolites modifications have not yet been fully developed, established that not only enzymatic transformations but also exogenous compounds from different environmental factors can contribute to production of new metabolites. We would like to comment some of advantages and challenges of HRMS and its future potential leading to interesting structural information that can direct the an1Fondazione Istituto Insubrico Ricerca per la Vita, 21040 Gerenzano (Va), Italy 2Istituto di Ricerche Chimiche e Biochimiche G. Ronzoni, 20133 Milan, Italy","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85885662","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Today’s bioanalysis outsourcing market is growing rapidly and, as CROs grow and evolve to meet market needs and market challenges, they also need to consider how they can offer additional value to their sponsors in the face of increased competition. Effective CROs are adapting their offerings to meet the growing biologics space, whilst optimizing their processes to be more efficient in delivering timely methods, audits, and results to sponsors whilst adhering to the regulatory expectations. Making your teams more effective enables you do to much more work with the same resources and frees up employees to support emerging techniques and this is all possible through the adoption of process control through software, such as LES (Lab Execution Systems) and ELN (Electronic Laboratory Notebook) systems.
{"title":"How CROs can gain a Competitive Advantage in the Bioanalysis Market","authors":"M. Clifford","doi":"10.17145/JAB.18.015","DOIUrl":"https://doi.org/10.17145/JAB.18.015","url":null,"abstract":"Today’s bioanalysis outsourcing market is growing rapidly and, as CROs grow and evolve to meet market needs and market challenges, they also need to consider how they can offer additional value to their sponsors in the face of increased competition. Effective CROs are adapting their offerings to meet the growing biologics space, whilst optimizing their processes to be more efficient in delivering timely methods, audits, and results to sponsors whilst adhering to the regulatory expectations. Making your teams more effective enables you do to much more work with the same resources and frees up employees to support emerging techniques and this is all possible through the adoption of process control through software, such as LES (Lab Execution Systems) and ELN (Electronic Laboratory Notebook) systems.","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89563184","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A. Charnot, D. Gouveia, S. Ayciriex, J. Lemoine, J. Armengaud, C. Almunia, A. Chaumot, O. Geffard, A. Salvador
{"title":"On-Line Solid Phase Extraction Liquid Chromatography-Mass Spectrometry Method for Multiplexed Proteins Quantitation in an Ecotoxicology Test Specie: Gammarus fossarum","authors":"A. Charnot, D. Gouveia, S. Ayciriex, J. Lemoine, J. Armengaud, C. Almunia, A. Chaumot, O. Geffard, A. Salvador","doi":"10.17145/JAB.18.012","DOIUrl":"https://doi.org/10.17145/JAB.18.012","url":null,"abstract":"","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73163897","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Recently, the USFDA issued the new 2018 guidance document for industry on bioanalytical validation. Due to this occasion, it would be worthy to look back in time as well into the (near) future on potential practical impacts the 2018 guidance document might have on bioanalytical method validation and laboratory operations. Bioanalytical method development and validation is the most important part in regulated bioanalysis. Validated bioanalytical methods are used for the quantitative measurement of drugs and their metabolites, endogenous compounds, and biomarkers in biological fluids. Drug concentrations are indispensable for the evaluation and interpretation of pharmacokinetic (PK), toxicokinetic (TK), and bioequivalence (BE) study data. The bioanalytical methods are not only applied for quantification of small molecules (molecular weight ≤ 900 Da) but also for larger molecules such as proteins, antibodies, and peptides. Bioanalysis can be quite challenging due to the complexity of the biological sample matrix. In addition to the sample complexity, data quality obtained from analyzed samples is directly related to the bioanalytical method’s performance. Without any doubt, it is of utmost importance that bioanalytical methods used in bioanalysis have to provide reliable data. According to the USFDA is the purpose of bioanalytical method validation: 1) to validate operation conditions, limitations, and 2) to determine the method suitability for its intended purpose and 3) to ensure that the bioanalytical method is optimized for sample analysis. For a long time, method validation procedures and strategies used in bioanalysis, as well as acceptance criteria needed for validation procedures, were a matter of personal prejudice. Many years there existed a lack of guidance uniformity on bioanalytical method development and validation within the bioanalytical community. This suddenly changed when industrial committees and regulatory agencies initiated the development and introduction of guidance documents on bioanalytical method validation for industry [1]. The first USFDA guidance document for industry on bioanalytical method validation was issued as a draft guidance in January 1999. Two years later this draft guidance document was finalized after incorporation of public comments, and the guidance was released as an official guidance document in May 2001. The guidance docuMLM Medical Labs GmbH, Dohrweg 63, 41066 Mönchengladbach, Germany.
{"title":"Bioanalytical Method Development and Validation: from the USFDA 2001 to the USFDA 2018 Guidance for Industry","authors":"R. Meesters, Stephan Voswinkel","doi":"10.17145/JAB.18.010","DOIUrl":"https://doi.org/10.17145/JAB.18.010","url":null,"abstract":"Recently, the USFDA issued the new 2018 guidance document for industry on bioanalytical validation. Due to this occasion, it would be worthy to look back in time as well into the (near) future on potential practical impacts the 2018 guidance document might have on bioanalytical method validation and laboratory operations. Bioanalytical method development and validation is the most important part in regulated bioanalysis. Validated bioanalytical methods are used for the quantitative measurement of drugs and their metabolites, endogenous compounds, and biomarkers in biological fluids. Drug concentrations are indispensable for the evaluation and interpretation of pharmacokinetic (PK), toxicokinetic (TK), and bioequivalence (BE) study data. The bioanalytical methods are not only applied for quantification of small molecules (molecular weight ≤ 900 Da) but also for larger molecules such as proteins, antibodies, and peptides. Bioanalysis can be quite challenging due to the complexity of the biological sample matrix. In addition to the sample complexity, data quality obtained from analyzed samples is directly related to the bioanalytical method’s performance. Without any doubt, it is of utmost importance that bioanalytical methods used in bioanalysis have to provide reliable data. According to the USFDA is the purpose of bioanalytical method validation: 1) to validate operation conditions, limitations, and 2) to determine the method suitability for its intended purpose and 3) to ensure that the bioanalytical method is optimized for sample analysis. For a long time, method validation procedures and strategies used in bioanalysis, as well as acceptance criteria needed for validation procedures, were a matter of personal prejudice. Many years there existed a lack of guidance uniformity on bioanalytical method development and validation within the bioanalytical community. This suddenly changed when industrial committees and regulatory agencies initiated the development and introduction of guidance documents on bioanalytical method validation for industry [1]. The first USFDA guidance document for industry on bioanalytical method validation was issued as a draft guidance in January 1999. Two years later this draft guidance document was finalized after incorporation of public comments, and the guidance was released as an official guidance document in May 2001. The guidance docuMLM Medical Labs GmbH, Dohrweg 63, 41066 Mönchengladbach, Germany.","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79003900","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
During drug development, anti-drug antibodies (ADA) is closely monitored for immunogenicity assessment. Ligand binding assay is currently the most widely used platform for ADA detection. Very recently, immunocapture-LC/MS was developed for ADA analysis including isotyping and semi-quantitation. This mini-review summarizes literatures pertaining to immunocapture-LC/MS ADA analysis with focus on methodology, applications and regulatory aspects. Current thinking and considerations as well as outlook are also presented.
{"title":"Current Status of Anti-Drug Antibody Analysis Using Immunocapture-Liquid Chromatography/Mass Spectrometry","authors":"Lin-Zhi Chen","doi":"10.17145/JAB.18.011","DOIUrl":"https://doi.org/10.17145/JAB.18.011","url":null,"abstract":"During drug development, anti-drug antibodies (ADA) is closely monitored for immunogenicity assessment. Ligand binding assay is currently the most widely used platform for ADA detection. Very recently, immunocapture-LC/MS was developed for ADA analysis including isotyping and semi-quantitation. This mini-review summarizes literatures pertaining to immunocapture-LC/MS ADA analysis with focus on methodology, applications and regulatory aspects. Current thinking and considerations as well as outlook are also presented.","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87324194","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Meet our editorial board member: Dr. Victoria F. Samanidou","authors":"V. Samanidou","doi":"10.17145/JAB.18.006","DOIUrl":"https://doi.org/10.17145/JAB.18.006","url":null,"abstract":"","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75020054","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A. Daskapan, K. V. Hateren, Y. Stienstra, J. Kosterink, T. Werf, D. Touw, J. Alffenaar
OBJECTIVES: The aim was to develop and validate a LC-MS/MS assay to determine antiretrovirals in human plasma for routine therapeutic drug mon-itoring. METHODS: The selectivity, sensitivity, linearity, accuracy, precision, recovery, matrix effect, stability and dilution integrity and carry-over were validated ac-cording to EMA and FDA standards. RESULTS: For accuracy and precision, the highest overall bias was 11.3% at LLOQ of both lopinavir and saquinavir. The highest overall CV was 15.6% at the LLOQ of darunavir. Storage stability at 4°C, 20–25°C and 10°C had a maximum CV of 13.2% at low QC level (0.2 mg/L) for saquinavir. Freeze-thaw stability had a maximum overall bias of 7.4% at low QC level (0.8 mg/L) for tipranavir. Selectivity and specificity showed no interfering peaks of more than 20% of the LLOQ. CONCLUSIONS: The bioanalytical method is suitable for both TDM in stan-dard care and clinical studies. Werf T, Touw D, Alffenaar JW. Develop-ment and validation of a bioanalytical method for the simultaneous determi-nation of 14 antiretroviral drugs using liquid chromatography-tandem mass spectrometry. J Appl Bioanal 4(2), 37-50 (2018).
{"title":"Development and Validation of a Bioanalytical Method for the Simul- taneous Determination of 14 Antiretroviral Drugs using Liquid Chro- matography-Tandem Mass Spectrometry","authors":"A. Daskapan, K. V. Hateren, Y. Stienstra, J. Kosterink, T. Werf, D. Touw, J. Alffenaar","doi":"10.17145/JAB.18.007","DOIUrl":"https://doi.org/10.17145/JAB.18.007","url":null,"abstract":"OBJECTIVES: The aim was to develop and validate a LC-MS/MS assay to determine antiretrovirals in human plasma for routine therapeutic drug mon-itoring. METHODS: The selectivity, sensitivity, linearity, accuracy, precision, recovery, matrix effect, stability and dilution integrity and carry-over were validated ac-cording to EMA and FDA standards. RESULTS: For accuracy and precision, the highest overall bias was 11.3% at LLOQ of both lopinavir and saquinavir. The highest overall CV was 15.6% at the LLOQ of darunavir. Storage stability at 4°C, 20–25°C and 10°C had a maximum CV of 13.2% at low QC level (0.2 mg/L) for saquinavir. Freeze-thaw stability had a maximum overall bias of 7.4% at low QC level (0.8 mg/L) for tipranavir. Selectivity and specificity showed no interfering peaks of more than 20% of the LLOQ. CONCLUSIONS: The bioanalytical method is suitable for both TDM in stan-dard care and clinical studies. Werf T, Touw D, Alffenaar JW. Develop-ment and validation of a bioanalytical method for the simultaneous determi-nation of 14 antiretroviral drugs using liquid chromatography-tandem mass spectrometry. J Appl Bioanal 4(2), 37-50 (2018).","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88771234","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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