2,444 results match your criteria Bioanalysis [Journal]


Effective presentation of immunogenicity risk assessments and related data in regulatory dossiers.

Authors:
Paul Chamberlain

Bioanalysis 2019 Feb 15. Epub 2019 Feb 15.

NDA Advisory Services, Ltd, Grove House, Guildford Road, Leatherhead, Surrey KT22 9DF, UK.

The purpose of this article is to provide practical advice about how to present immunogenicity-related information in regulatory dossiers, with a particular focus on a model for an Integrated Summary of Immunogenicity to be submitted in the marketing authorization application for novel biopharmaceutical products in ICH regions (EU, USA and Japan). A format that links the analysis of potential risk factors to a justification of the methodology applied for risk evaluation and conclusions for risk mitigation is presented as a model that can be adapted according to the weight of evidence to be submitted in support of the assessment of impact on overall clinical benefit versus risk for the particular situation. Read More

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http://dx.doi.org/10.4155/bio-2018-0209DOI Listing
February 2019

Toward highly sensitive and reproducible LC-MS/MS analysis of MK-8591 phosphorylated anabolites in human peripheral blood mononuclear cells.

Bioanalysis 2019 Feb 15. Epub 2019 Feb 15.

Department of Pharmacokinetics, Pharmacodynamics & Drug Metabolism, Merck & Co., Inc., West Point, PA, USA.

Aim: MK-8591 (EFdA), a novel anti-HIV nucleoside analog, is converted to mono-, di- and tri-phosphates (MK-8591-MP, MK-8591-DP and MK-8591-TP) intracellularly, among which MK-8591-TP is the active pharmacological form. An ultrasensitive LC-MS/MS assay was required to measure MK-8591-DP and MK-8591-TP levels in human peripheral blood mononuclear cells (PBMCs). Sensitivity and reproducibility were major bottlenecks in these analyses. Read More

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http://dx.doi.org/10.4155/bio-2018-0101DOI Listing
February 2019

A practical workflow for capillary microsampling in nonclinical studies.

Bioanalysis 2019 Feb 15. Epub 2019 Feb 15.

Bioanalytical Science, Bristol-Myers Squibb, Princeton, NJ 08543, USA.

Aim: The result of investigation on the procedure of sample handling and bioanalysis of small volume of plasma sample for nonclinical studies stored in 0.5-ml micronic tubes was reported. Results/methodology: Sample integrity of the small volume (25 μl) during long-term storage and the feasibility and data reliability of performing multiple re-assays on the small volume sample using 5 μl aliquot per analysis was evaluated. Read More

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http://dx.doi.org/10.4155/bio-2018-0224DOI Listing
February 2019

Direct quantitation of therapeutic antibodies for pharmacokinetic studies using immuno-purification and intact mass analysis.

Bioanalysis 2019 Feb 8. Epub 2019 Feb 8.

Pharmacokinetics, Pharmacodynamics & Drug Metabolism, Merck & Co., Inc., 770 Sumneytown Pike, West Point, PA 19486, USA.

Aim: The quantitation of therapeutic antibodies by MS often utilizes a surrogate peptide approach. Recent enhancements in instrumentation and sample preparation have enabled quantitation by detection of the intact molecule using MS. Experimental Methods & Results: A comparison of three methods for quantitative analysis of therapeutic monoclonal antibodies including analysis after deglycosylation, after hinge digestion and at the fully intact antibody level is reported. Read More

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http://dx.doi.org/10.4155/bio-2018-0240DOI Listing
February 2019

Welcome to the 11th volume of Bioanalysis.

Authors:
Rhiannon Finnie

Bioanalysis 2019 Jan;11(1):1-5

Future Science Group, Unitec House, 2 Albert Place, London N31QB, UK.

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http://dx.doi.org/10.4155/bio-2018-0289DOI Listing
January 2019

Evaluation of polysaccharide-based chiral stationary phases in modern SFC-MS/MS for enantioselective bioanalysis.

Bioanalysis 2019 Jan 23. Epub 2019 Jan 23.

Drug Metabolism & Pharmacokinetics, Genentech Inc. 1 DNA Way, South San Francisco, CA 94080, USA.

Aim: The applicability of polysaccharide-based chiral stationary phases in modern supercritical fluid chromatography (SFC)-MS/MS for chiral bioanalysis was evaluated.

Materials & Methods: Ten popular polysaccharide-based chiral stationary phases (CSPs) were tested using a set of 23 drugs against three cosolvents. The effect of temperature and backpressure on separation was examined. Read More

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https://www.future-science.com/doi/10.4155/bio-2018-0168
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http://dx.doi.org/10.4155/bio-2018-0168DOI Listing
January 2019
4 Reads

Compatibility of immunogenicity guidance by the EMA and the US FDA.

Authors:
Pekka Kurki

Bioanalysis 2019 Jan 23. Epub 2019 Jan 23.

University of Helsinki, Clinical Immunology, Lukupolku 19, FI-00680 Helsinki, Finland.

The guidelines for immunogenicity studies by the European Medicines Agency and the US FDA are based on different legislations and regulatory philosophies. In spite of the different background, the main guidelines are compatible on the scientific level, especially for new innovative therapeutic protein products. The importance of sensitive and drug-tolerant antidrug antibody assays and multidisciplinary approach to development and assessment are highlighted by both agencies. Read More

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http://dx.doi.org/10.4155/bio-2018-0243DOI Listing
January 2019

HPLC-MS/MS-based analysis of everolimus in rabbit aqueous humor: pharmacokinetics of in situ gel eye drops of suspension.

Bioanalysis 2019 Jan 21. Epub 2019 Jan 21.

College of Pharmaceutical Sciences, Zhejiang University of Technology, Hangzhou 310014, PR China.

Aim: Everolimus is an inhibitor of mTOR which is derived from rapamycin. Its high corneal permeability and bioavailability makes it an effective treatment for ocular disorders. To study the pharmacokinetics of in situ gel eye drops of everolimus suspension after ocular administration in rabbit aqueous humor, we developed a rapid and reliable HPLC-MS/MS method. Read More

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http://dx.doi.org/10.4155/bio-2018-0227DOI Listing
January 2019
1 Read
3.003 Impact Factor

Perspectives and strategies for anti-doping analysis.

Bioanalysis 2019 Jan 21. Epub 2019 Jan 21.

Department of Pharmacy & Biotechnology (FaBiT), Alma Mater Studiorum - University of Bologna, Bologna, Italy.

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http://dx.doi.org/10.4155/bio-2018-0290DOI Listing
January 2019
1 Read

Current direction and advances in analytical sample extraction techniques for drugs with special emphasis on bioanalysis.

Bioanalysis 2019 Jan 21. Epub 2019 Jan 21.

National Institute of Pharmaceutical Education & Research (NIPER) - Ahmedabad, Gujarat, India.

Analytical techniques may not be compatible or sufficiently sensitive to the analytes, unless it undergoes a specific sample extraction procedure. Sample extraction can be considered as one of the key steps in analysis. Analysis of a poorly treated sample may produce inferior quality of analytical data. Read More

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http://dx.doi.org/10.4155/bio-2018-0144DOI Listing
January 2019
1 Read

Green sample preparations for the bioanalysis of drugs of abuse in complex matrices.

Bioanalysis 2019 Jan 21. Epub 2019 Jan 21.

Department of Clinical & Toxicological Analyses, School of Pharmaceutical Sciences, University of São Paulo, Av. Professor Lineu Prestes, 580, 13B, São Paulo, SP 05508-000, Brazil.

The sample preparation is the most critical step involved in the bioanalytical process. When dealing with green analytical chemistry, sample preparation can be even more challenging. To fit the green analytical chemistry principles, efforts should be made toward the elimination or reduction of the use of toxic reagents and solvents, minimization of energy consumption and increased operator safety. Read More

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http://dx.doi.org/10.4155/bio-2018-0208DOI Listing
January 2019
1 Read

Schizophrenia: recent advances in LC-MS/MS methods to determine antipsychotic drugs in biological samples.

Bioanalysis 2019 Jan 21. Epub 2019 Jan 21.

Department of Neuroscience & Behavior, Ribeirão Preto Medical School, University of São Paulo, São Paulo, Brazil.

Schizophrenia is one of the most debilitating and costly illnesses worldwide. First-generation antipsychotics such as chlorpromazine and haloperidol succeeded in controlling the positive symptoms of schizophrenia, but had significant extrapyramidal effects that led to the search for new agents and the release of second-generation (or atypical) antipsychotics. These drugs had a lower risk of adverse motor symptoms. Read More

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http://dx.doi.org/10.4155/bio-2018-0155DOI Listing
January 2019
2 Reads

Retention time bracketing for targeted sphingolipidomics by liquid chromatography-tandem mass spectrometry.

Bioanalysis 2019 Jan 21. Epub 2019 Jan 21.

Translational 'Omics & Biomarkers Group, KK Research Centre, KK Women's & Children's Hospital, 100 Bukit Timah Road, Singapore, 229899, Singapore.

Aim: In complex biological matrixes, many sphingolipids are present with multiple reaction monitoring traces or lack of standard for verification, potentially leading to inaccurate identification and quantitation. Results/methodology: Based on these retention times of available standards, we devised a retention time bracketing approach to identify and predict sphingolipids of the same homologous series. Excellent concordance of predicted and observed retention times (<0. Read More

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http://dx.doi.org/10.4155/bio-2018-0036DOI Listing
January 2019
1 Read

Simultaneous quantification of high-dose naloxone and naloxone-3-β-d-glucuronide in human plasma by UHPLC-MS/MS.

Bioanalysis 2019 Jan 21. Epub 2019 Jan 21.

Department of Drug Design & Pharmacology, Faculty of Health & Medical Sciences, University of Copenhagen, Universitetsparken 2, DK-2100 Copenhagen, Denmark.

Aim: High-dose administration of the μ-opioid receptor inverse agonist naloxone (NX), has previously been demonstrated to reinstate nocifensive behavior in the late phase of inflammatory injuries. However, no current analytical methods can provide pharmacokinetic insight into the pharmacodynamic response of high-dose administration of NX.

Materials & Methods:  Based on protein precipitation using 50 μl human plasma, NX and naloxone-β-d-glucuronide (NXG) was analysed by UHPLC-MS/MS with 6 min cycle time. Read More

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http://dx.doi.org/10.4155/bio-2018-0134DOI Listing
January 2019
2 Reads

Use of Ella to facilitate drug quantification and antidrug antibody detection in preclinical studies.

Bioanalysis 2019 Jan 10. Epub 2019 Jan 10.

Pharmaceutical Sciences, Pharma Research & Early Development, Roche Innovation Center Munich, Nonnenwald 2, 82377 Penzberg, Germany.

Aim: To explore the usability of the Ella platform for preclinical analysis of therapeutic antibodies and antidrug antibodies (ADA).

Experimental: Two well-established ELISAs for the measurement of human IgG and ADA were transferred to the Ella platform. ELISA and the Ella platform were compared using assay qualification data and results of preclinical sample analysis. Read More

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https://www.future-science.com/doi/10.4155/bio-2018-0288
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http://dx.doi.org/10.4155/bio-2018-0288DOI Listing
January 2019
3 Reads

Voltammetric analysis of dantrolene and its active metabolite with indomethacin in rat plasma.

Bioanalysis 2019 Jan 12;11(2):73-84. Epub 2018 Dec 12.

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, University of Alexandria, El-Messalah, Alexandria 21521, Egypt.

Aim: Differential pulse polarography was used for the concurrent analysis of the coadministered dantrolene (DAN) and indomethacin (IND) in plasma.

Materials & Methods: DAN and IND, Hanging mercury drop electrode and Britton-Robinson buffer at pH 5 were used. In plasma, cathodic reduction of DAN nitro group and its active metabolite at -0. Read More

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http://dx.doi.org/10.4155/bio-2018-0165DOI Listing
January 2019
2 Reads

Miniaturized sample preparation methods for saliva analysis.

Bioanalysis 2019 Jan 12;11(2):119-148. Epub 2018 Dec 12.

Department of Chemistry, Faculty of Science, Qom University, Qom, Iran.

Saliva, as the first body fluid encountering with the exogenous materials, has good correlation with blood and plays an important role in bioanalysis. However, saliva has not been studied as much as the other biological fluids mainly due to restricted access to its large volumes. In recent years, there is a growing interest for saliva analysis owing to the emergence of miniaturized sample preparation methods. Read More

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http://dx.doi.org/10.4155/bio-2018-0160DOI Listing
January 2019
2 Reads

Juvenile rat and pediatric trazodone studies: how to gain extra sensitivity to overcome bioanalytical challenges.

Bioanalysis 2019 Jan 10;11(1):21-32. Epub 2018 Dec 10.

Angelini RR&D (Research, Regulatory & Development), Angelini SpA, Piazzale della Stazione snc, 00071 - S Palomba-Pomezia (Rome), Italy.

Aim: Trazodone (TZD) is used for the treatment of depression in adults and, off-label, as a sleep medication in adult and pediatric populations. The off-label use is well documented, however further clinical studies are needed to confirm its efficacy and safety for the treatment of sleep disorders. In this scenario, we developed a bioanalytical method to quantify low TZD concentrations in samples collected by capillary microsampling (CMS) to support dose finding, Good Laboratory Practice juvenile rat toxicokinetic and upcoming pediatric studies. Read More

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https://www.future-science.com/doi/10.4155/bio-2018-0236
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http://dx.doi.org/10.4155/bio-2018-0236DOI Listing
January 2019
9 Reads

2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity).

Bioanalysis 2018 Nov 29. Epub 2018 Nov 29.

F Hoffmann-La Roche, Basel, Switzerland.

The 2018 12 Workshop on Recent Issues in Bioanalysis took place in Philadelphia, PA, USA on April 9-13, 2018 with an attendance of over 900 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event - a full immersion week of bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small- and large-molecule bioanalysis involving LCMS, hybrid LBA/LCMS and LBA/cell-based assays approaches. Read More

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http://dx.doi.org/10.4155/bio-2018-0285DOI Listing
November 2018
19 Reads

2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays).

Bioanalysis 2018 Nov 29. Epub 2018 Nov 29.

Amador Bioscience, Pleasanton, CA, USA (formerly of OncoMed, Redwood City, CA, USA).

The 2018 12 Workshop on Recent Issues in Bioanalysis took place in Philadelphia, PA, USA on April 9-13, 2018 with an attendance of over 900 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day full immersion in bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small- and large-molecule bioanalysis involving LCMS, hybrid LBA/LCMS and LBA/cell-based assays approaches. Read More

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http://dx.doi.org/10.4155/bio-2018-0287DOI Listing
November 2018
16 Reads

2018 White Paper on Recent Issues in Bioanalysis: 'A global bioanalytical community perspective on last decade of incurred samples reanalysis (ISR)' (Part 1 - small molecule regulated bioanalysis, small molecule biomarkers, peptides & oligonucleotide bioanalysis).

Bioanalysis 2018 Nov 29;10(22):1781-1801. Epub 2018 Nov 29.

UK MHRA, London, UK.

The 2018 12 Workshop on Recent Issues in Bioanalysis (12th WRIB) took place in Philadelphia, PA, USA on April 9-13, 2018 with an attendance of over 900 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day full immersion in bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small- and large-molecule bioanalysis involving LC-MS, hybrid ligand binding assay (LBA)/LC-MS and LBA/cell-based assays approaches. Read More

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http://dx.doi.org/10.4155/bio-2018-0268DOI Listing
November 2018
14 Reads
3.003 Impact Factor

Transdermal sampling of vitamin D and 25-hydroxyvitamin D.

Bioanalysis 2019 Jan 26;11(2):61-72. Epub 2018 Nov 26.

Department of Pharmaceutical Sciences, Albany College of Pharmacy & Health Sciences, 106 New Scotland Avenue, Albany, NY 12208, USA.

Aim: Transdermal analysis is proposed for vitamin D and its hydroxylated metabolite to overcome problems associated with blood analysis.

Methods: Vitamin D was extracted directly from skin with solid patches and liquid phases. Deuterium-labeled vitamin D was added to the extraction solutions to compensate for variability and accurately determine the rate of transdermal transfer. Read More

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https://www.future-science.com/doi/10.4155/bio-2018-0138
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http://dx.doi.org/10.4155/bio-2018-0138DOI Listing
January 2019
2 Reads

Analytical techniques for characterization of biological molecules - proteins and aptamers/oligonucleotides.

Bioanalysis 2019 Jan 26;11(2):103-117. Epub 2018 Nov 26.

Discipline of Biosciences & Biomedical Engineering, Indian Institute of Technology Indore, Indore 453552, India.

With the advent of the high-throughput technologies and exciting times for biology, the discipline of analytical methodology is experiencing a surge in the growth and the scope. Over the years, multitude of analytical techniques have evolved from a work-intensive, low sensitivity and high volume of reagent and sample consumption endeavor to automated, better selectivity, lower limit of quantification and cost-effective techniques for biological research. In this review, we give an overview of the currently available wide range of cell-based and noncell based and structural based analytical techniques, their principle and biological applications. Read More

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https://www.future-science.com/doi/10.4155/bio-2018-0225
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http://dx.doi.org/10.4155/bio-2018-0225DOI Listing
January 2019
3 Reads
3.003 Impact Factor

On-line monitoring human breath acetone during exercise and diet by proton transfer reaction mass spectrometry.

Bioanalysis 2019 Jan 26;11(1):33-40. Epub 2018 Nov 26.

Anhui Province Key Laboratory of Medical Physics & Technology, Center of Medical Physics & Technology, Hefei Institutes of Physical Science, Chinese Academy of Sciences, Hefei, Anhui, PR China.

Aim: This study aims to develop a method for monitoring fat loss by detection of breath acetone.

Methods: A new method combining direct breath sampling system and proton transfer reaction MS (PTR-MS) was developed for on-line detection of breath acetone. The breath acetone of 272 volunteers was detected respectively when exercise or diet. Read More

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https://www.future-science.com/doi/10.4155/bio-2018-0258
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http://dx.doi.org/10.4155/bio-2018-0258DOI Listing
January 2019
10 Reads

European Bioanalysis Forum recommendation on the best practices to demonstrate processed sample stability.

Bioanalysis 2019 Jan 26;11(1):7-11. Epub 2018 Nov 26.

European Bioanalysis Forum, Havenlaan 86c B204, 1000 Brussels, Belgium.

The European Bioanalysis Forum is providing a proposal on experiments to be conducted if processed samples are to be stored for a period of time, either after an initial injection or if processed samples are to be stored for a period of time prior to their first injection. Using survey information and extensive discussion an insight was gained as to whether the current practices employed during method validation were conducted to scientifically validate actual sample handling conditions or to simply meet a perceived regulatory expectation. The goal of this report is to recommend the adoption of scientifically justified validation experiments that exactly reproduce and processed test sample handling and storage procedures and to introduce some uniformity across the industry. Read More

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https://www.future-science.com/doi/10.4155/bio-2018-0271
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http://dx.doi.org/10.4155/bio-2018-0271DOI Listing
January 2019
11 Reads

A novel HPLC-DAD method for simultaneous determination of febuxostat and diclofenac in biological samples: pharmacokinetic outcomes.

Bioanalysis 2019 Jan 26;11(1):41-54. Epub 2018 Nov 26.

Department of Pharmacology & Toxicology, Faculty of Pharmacy, Alexandria University, El-Messalah, Alexandria 21521, Egypt.

Aim: To develop a simple HPLC-DAD method for simultaneous determination of febuxostat (FEB) and diclofenac (DIC) in biological samples to assess pharmacokinetic outcomes of their coadministration. Methodology & results: Sample preparation was performed by liquid-liquid extraction. Drugs analysis was done on C18 column using methanol-formic acid pH 2. Read More

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http://dx.doi.org/10.4155/bio-2018-0219DOI Listing
January 2019
1 Read

The importance of evaluating the chemical structures and strategies to avoid pitfalls in quantitative bioanalysis.

Bioanalysis 2019 Jan 26;11(2):85-101. Epub 2018 Nov 26.

Bioanalysis, Immunogenicity, & Biomarkers, PTS-In Vivo/In Vitro Translation, GlaxoSmithKline Pharmaceuticals, 709 Swedeland Road, King of Prussia, PA 19406, USA.

Quantitative bioanalytical data are crucial in pharmaceutical research and development, allowing project teams to make informed scientific decisions on the progression of candidate molecules to medicines. Many challenges are often encountered during the bioanalysis of drugs in biological matrices which require resolution in a timely manner. In this publication, guidance is provided to bioanalytical scientists on how to identify potential problems before they become an obstacle for the drug development and to share our experiences dealing some of most common problems encountered in the bioanalytical laboratory. Read More

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https://www.future-science.com/doi/10.4155/bio-2018-0211
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http://dx.doi.org/10.4155/bio-2018-0211DOI Listing
January 2019
2 Reads

Application of Mitra microsampling for pharmacokinetic bioanalysis of monoclonal antibodies in rats.

Bioanalysis 2019 Jan 21;11(1):13-20. Epub 2018 Nov 21.

Biotherapeutics Discovery, Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road, Ridgefield CT 06877, USA.

Aim: Volumetric absorptive microsampling (VAM) is being increasingly applied in nonclinical pharmacokinetic studies. Although there are published results for VAM use in small molecule pharmacokinetics (PK) studies, there is limited data on the utility of VAM for protein therapeutics.

Results: We describe the use of Mitra microsampler for blood sampling, ELISA quantitation and PK analysis of two marketed therapeutic monoclonal antibodies administered to rat. Read More

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http://dx.doi.org/10.4155/bio-2018-0228DOI Listing
January 2019
1 Read

Validation and clinical application of a novel LC-MS method for quantification of dolutegravir in breast milk.

Bioanalysis 2018 Nov 19. Epub 2018 Nov 19.

Department of Molecular & Clinical Pharmacology, University of Liverpool, 70 Pembroke Place, Liverpool, L69 3GF, UK.

Aim: A novel, sensitive and reproducible method for quantification of dolutegravir (DTG) in dried breast milk spots (DBMS) was developed and validated for use in clinical studies. Its application enabled measurement of DTG pharmacokinetics in breastfeeding mothers and their infants. Results/methodology: Sample extraction was by liquid-liquid extraction using Tert-butyl methy-ether, with DTG-d5 as an internal standard. Read More

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http://dx.doi.org/10.4155/bio-2018-0085DOI Listing
November 2018
6 Reads

Development of paper substrate for paper spray MS in high-sensitivity analysis of biological samples.

Bioanalysis 2018 Nov 16. Epub 2018 Nov 16.

College of Chemistry & Chemical Engineering, Xi'an Shiyou University, Xi'an 710065, PR China.

Paper spray (PS) has demonstrated a promising future for direct mass spectrometric analysis. In the process of PS, paper substrate has been demonstrated as a crucial factor in determining the final performance of PS-MS, and therefore much attention is paid to modification of paper substrate. In this review, we systematically introduce the development of paper substrate for PS. Read More

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http://dx.doi.org/10.4155/bio-2018-0199DOI Listing
November 2018
2 Reads

Biomarker assays: is it time for a standalone regulatory guidance?

Bioanalysis 2018 Dec 16;10(23):1893-1895. Epub 2018 Nov 16.

Biogen, 225 Binney Street, Cambridge, MA 02142, USA.

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http://dx.doi.org/10.4155/bio-2018-0279DOI Listing
December 2018
1 Read

Incurred sample reproducibility: what have we learned and how can we build on our learnings?

Authors:
Philip Timmerman

Bioanalysis 2018 Nov 13;10(21):1707-1709. Epub 2018 Nov 13.

European Bioanalysis Forum, Havenlaan 86c b204, 1000 Brussels, Belgium.

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http://dx.doi.org/10.4155/bio-2018-0275DOI Listing
November 2018
1 Read

Analyzing protein glycosylation using UHPLC: a review.

Bioanalysis 2018 Oct;10(20):1691-1703

Department of Chemistry, Valparaiso University, 1710 Chapel Drive, Valparaiso, IN 46383, USA.

Ultrahigh performance liquid chromatography (UHPLC) uses small stationary-phase particle size (<2 μm) and high pressure in order to achieve rapid and efficient separations. The speed and high resolution of this method has made it a valuable tool for analyzing the complex glycosylation patterns found in post-translationally modified proteins. This article highlights the differences between UHPLC and HPLC and reviews recent UHPLC applications and developments for detecting glycosylated proteins (e. Read More

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http://dx.doi.org/10.4155/bio-2018-0156DOI Listing
October 2018
1 Read

A UHPLC-MS/MS method for the quantification of Δ9-tetrahydrocannabinol and cannabidiol in decoctions and in plasma samples for therapeutic monitoring of medical cannabis.

Bioanalysis 2018 11 6. Epub 2018 Nov 6.

Department of Services and Diagnostic Laboratories, Central Laboratory of Analyses Unit, IRCCS Istituto Giannina Gaslini, 16143 Genoa, Italy.

Aim: Monitoring of blood levels of Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD) is necessary for optimization of administration of medical cannabis. We describe the validation of a ultra-HPLC-MS/MS method for quantifying THC and CBD from plasma and decoctions and its application for therapeutic drug monitoring.Materials & methods: Analyses were performed by using a TSQ Quantiva™ Triple Quadrupole coupled to a Ultimate 3000 UHPLC system with atmospheric pressure chemical ionization after sample preparation with a straightforward method with deuterated internal standards. Read More

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https://www.future-science.com/doi/10.4155/bio-2018-0184
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http://dx.doi.org/10.4155/bio-2018-0184DOI Listing
November 2018
8 Reads

LC-MS/MS method for screening of intoxication and drug adherence of angiotensin-converting enzyme inhibitors in plasma.

Bioanalysis 2018 Nov 6. Epub 2018 Nov 6.

Institute of Clinical Pharmacy & Pharmacotherapy, Heinrich-Heine University, Dusseldorf 40225, Germany.

Aim: Intentional and accidental drug intoxication as well as medication adherence require sensitive and reliable analytical screening methods. Such methods are often lacking in children and adults, therefore, a reliable analytical method has been developed by using low plasma volume.

Materials & Methods: Sample preparation from plasma was achieved by solid-phase extraction process. Read More

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https://www.future-science.com/doi/10.4155/bio-2018-0200
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http://dx.doi.org/10.4155/bio-2018-0200DOI Listing
November 2018
10 Reads

Quantification of eicosanoids and their metabolites in biological matrices: a review.

Bioanalysis 2018 Dec 6;10(24):2027-2046. Epub 2018 Nov 6.

Department of Pharmacy Practice, College of Pharmacy, University of Nebraska Medical Center, Omaha, NE 68198, USA.

The quantification of eicosanoids and their metabolites in biological samples remain an analytical challenge, even though a number of methodologies/techniques have been developed. The major difficulties encountered are related to the oxidation of eicosanoids and their low quantities in biological matrices. Among the known methodologies, liquid chromatography-mass spectrometry (LC-MS/MS) is the standard method for eicosanoid quantification in biological samples. Read More

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http://dx.doi.org/10.4155/bio-2018-0173DOI Listing
December 2018
1 Read
3.003 Impact Factor

Evaluation of the Mitra microsampling device for use with key urinary metabolites in patients with Alkaptonuria.

Bioanalysis 2018 Dec 6;10(23):1919-1932. Epub 2018 Nov 6.

Department of Clinical Biochemistry & Metabolic Medicine, Liverpool Clinical Laboratories, Royal Liverpool University Hospital, Liverpool, L7 8XP, UK.

Aim: Alkaptonuria is a disorder of tyrosine metabolism where elevated circulating homogentisic acid causes progressive dysfunction of collagenous tissues. Logistical, financial and patient experience concerns with collection and transport of specimens to central laboratories makes evaluation of microsampling attractive.

Methodology: Volumetric absorptive microsampling devices were evaluated for accuracy, precision and drying time. Read More

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https://www.future-science.com/doi/10.4155/bio-2018-0193
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http://dx.doi.org/10.4155/bio-2018-0193DOI Listing
December 2018
7 Reads
3.003 Impact Factor

Quantitative profiling of cortisol metabolites in human urine by high-resolution accurate-mass MS.

Bioanalysis 2018 Dec 6;10(24):2015-2026. Epub 2018 Nov 6.

Department of Medicinal Chemistry, College of Pharmacy, University of Florida, Gainesville, FL 32610, USA.

Aim, materials & methods: Urinary cortisol profile has the potential as a diagnostic biomarker. We therefore developed a stable-isotope dilution ultraperformance chromatography multistage MS-based method to quantify cortisol and 16 metabolites in human urines. Results & conclusion: The LOD for cortisol and its metabolites ranges from 0. Read More

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http://dx.doi.org/10.4155/bio-2018-0182DOI Listing
December 2018
1 Read

A look back at the incurred sample reanalysis.

Authors:
Faye Vazvaei

Bioanalysis 2018 Nov 6;10(21):1711-1713. Epub 2018 Nov 6.

Pharmaceutical Research & Early Development Roche Innovation Center, Roche Innovation Center New York, New York, NY 10016, USA.

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http://dx.doi.org/10.4155/bio-2018-0263DOI Listing
November 2018
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Analytical Quality by Design-based development and validation of ultra pressure liquid chromatography/MS/MS method for glycopeptide antibiotics determination in human plasma.

Bioanalysis 2018 Nov 6;10(22):1861-1876. Epub 2018 Nov 6.

Department of Drug Analysis, Faculty of Pharmacy, University of Belgrade, Vojvode Stepe 450, Belgrade, Serbia.

Aim: An ultra pressure liquid chromatography (UPLC)/MS/MS method for vancomycin and teicoplanin determination in human plasma was developed in accordance with analytical quality by design (AQbD) concept and fully validated.

Materials & Methods: Chromatographic separation was performed on ACQUITY UPLC C charge surface hybrid (CSH) column (2.1 mm × 50 mm, 1. Read More

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https://www.future-science.com/doi/10.4155/bio-2018-0181
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http://dx.doi.org/10.4155/bio-2018-0181DOI Listing
November 2018
9 Reads

Incurred sample reproducibility: 10 years of experiences: views and recommendations from the European Bioanalysis Forum.

Bioanalysis 2018 Nov 6;10(21):1723-1732. Epub 2018 Nov 6.

European Bioanalysis Forum, Brussels, Belgium.

With 10 years of experiences on incurred sample reanalysis (ISR) as an integrated part of regulated bioanalysis, the European Bioanalysis Forum has reflected on the implementation and the use of ISR. Three surveys were conducted in 2016 and 2017 as a revisit of the ISR experiences within European pharmaceutical industry and contract research organizations: has ISR become a tool for postvalidation and process check of a bioanalytical method performance and has ISR become a routine in our laboratories? Do we agree on the interpretation of guidelines/guidance and are we aligned in our approach - among others? Read More

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http://dx.doi.org/10.4155/bio-2018-0194DOI Listing
November 2018
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Enzymatic assay of D-mannose from urine.

Bioanalysis 2018 Dec 6;10(23):1947-1954. Epub 2018 Nov 6.

Department of Biological Sciences, UT Dallas, Richardson, TX 75080, USA.

Aim: Urinary tract infections (UTIs) are increasingly antibiotic resistant, and alternate or adjunct therapies are urgently needed. Several studies suggest that D-mannose ingestion and a hypothesized increase in urinary D-mannose reduce UTI frequency. Our goal was to develop a reliable assay for urinary D-mannose, which is needed to assess the effects of supplemental D-mannose on urinary D-mannose and UTIs. Read More

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http://dx.doi.org/10.4155/bio-2018-0121DOI Listing
December 2018
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Incurred sample reproducibility in pharmacokinetic bioanalysis: pros and cons from a CRO perspective.

Bioanalysis 2018 Nov 6;10(21):1715-1717. Epub 2018 Nov 6.

PPD, Immunochemistry, Richmond, VA 23230, USA.

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http://dx.doi.org/10.4155/bio-2018-0245DOI Listing
November 2018
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Bioanalytical workflow for novel scaffold protein-drug conjugates: quantitation of total Centyrin protein, conjugated Centyrin and free payload for Centyrin-drug conjugate in plasma and tissue samples using liquid chromatography-tandem mass spectrometry.

Bioanalysis 2018 Oct 29;10(20):1651-1665. Epub 2018 Oct 29.

Janssen Research & Development, Johnson&Johnson, 1400 McKean Road, PA 19477, USA.

Aim: Alternative scaffold proteins have emerged as novel platforms for development of therapeutic applications. One such application is in protein-drug conjugates (PDCs), which are analogous to antibody-drug conjugates.

Methodology: Liquid chromatography-mass spectrometry methods for quantitation of total protein, conjugate and free payload for a PDC based on Centyrin scaffold were developed. Read More

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https://www.future-science.com/doi/10.4155/bio-2018-0201
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http://dx.doi.org/10.4155/bio-2018-0201DOI Listing
October 2018
15 Reads

Advancing the analysis of terbutaline in urine samples using novel enzyme hydrolysis.

Bioanalysis 2018 Oct 29. Epub 2018 Oct 29.

Department of Chemistry & Biochemistry, University of South Carolina, Columbia, SC 29208, USA.

Aim: To investigate the efficiency of two new fast-acting enzymes, recombinant arylsulfatase (IMCS-PSF) and mutant β-glucuronidase from Escherichia coli (IMCSzyme), in hydrolyzing specific terbutaline metabolites.

Materials & Methods: Two purified novel enzymes are used to precisely determine the amount of each metabolite in urine at different time points after oral administration. After systematically evaluating the hydrolysis efficiency of the novel enzymes compared with commercially available enzymes, these recently developed enzymes were applied to establish the separate urine concentration profiles of terbutaline and each metabolite. Read More

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https://www.future-science.com/doi/10.4155/bio-2018-0145
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http://dx.doi.org/10.4155/bio-2018-0145DOI Listing
October 2018
7 Reads
3.003 Impact Factor

Workshop on Recent Issues in Bioanalysis (WRIB) Poster Award winners 2018.

Bioanalysis 2018 Oct 29;10(20):1635-1638. Epub 2018 Oct 29.

Exsera Biolabs, Colorado, USA.

The 12th WRIB held in Philadelphia, USA in April 2018. It drew over 900 professionals representing large Pharmas, Biotechs, Contract Research Organizations and multiple regulatory agencies from around the world, from the global bioanalytical community. Bioanalysis and Bioanalysis Zone are very proud to be supporting the WRIB Poster Awards again this year, and we feature the profiles of the authors of the winning posters. Read More

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https://www.future-science.com/doi/10.4155/bio-2018-0244
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http://dx.doi.org/10.4155/bio-2018-0244DOI Listing
October 2018
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Perspectives on potentiating immunocapture-LC-MS for the bioanalysis of biotherapeutics and biomarkers.

Bioanalysis 2018 Oct 29;10(20):1679-1690. Epub 2018 Oct 29.

Department of Drug Metabolism & Pharmacokinetics, Takeda Pharmaceuticals International Co, 35 Landsdowne Street, Cambridge, MA 02139, USA.

The integration of ligand-binding assay and LC-MS/MS (immunocapture-LC-MS) has unleashed the combined advantages of both powerful techniques for addressing the ever increasing bioanalytical challenges for biotherapeutics and biomarker assays. The highly specific, selective and sensitive characteristics of the immunocapture-LC-MS-based assays have enabled the determination of biotherapeutics and biomarkers in biomatrices with ease of method development, less requirements on key reagents as well as structural specificity for endogenous and engineered biomolecules. In addition, the versatile immunocapture-LC-MS technology has expanded into many challenging areas to enhance mechanistic studies of drug interactions with their targets. Read More

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https://www.future-science.com/doi/10.4155/bio-2018-0205
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http://dx.doi.org/10.4155/bio-2018-0205DOI Listing
October 2018
7 Reads

Feedback from the fourth European Bioanalysis Forum Young Scientist Symposium.

Bioanalysis 2018 Oct 24;10(20):1631-1634. Epub 2018 Oct 24.

European Bioanalysis Forum vzw, Brussels, Belgium.

Since 2014, the European Bioanalysis Forum organizes a Young Scientist Symposium. The meeting format was created to provide development opportunities for young scientists to engage in international discussions. Creating a peer community of young scientists has been a proven recipe to lower the threshold and promote engagement in this community of young talents. Read More

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http://dx.doi.org/10.4155/bio-2018-0222DOI Listing
October 2018
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Development of SPE method for the extraction of phosphorothioate oligonucleotides from serum samples.

Bioanalysis 2018 Oct 24;10(20):1667-1677. Epub 2018 Oct 24.

Chair of Environmental Chemistry & Bioanalytics, Faculty of Chemistry, Nicolaus Copernicus University in Toruń, 7 Gagarin Str, PL-87-100 Toruń, Poland.

Aim: Comprehensive development of a method for SPE extraction of antisense phosphorothioate oligonucleotide and its metabolites and their determination with the use of UHPLC.

Results: Polymer-based adsorbent and high percentage of methanol in elution solvent provided high recoveries compared with silica-based octadecyl cartridge. As to the type and concentration of ion pair reagent and organic solvent, the mixture of 5 mM of N,N-dimethylbutylamine/150 mM of 1,1,1,3,3,3-hexafluoroisopropanol and methanol was selected. Read More

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https://www.future-science.com/doi/10.4155/bio-2018-0166
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http://dx.doi.org/10.4155/bio-2018-0166DOI Listing
October 2018
2 Reads