2,502 results match your criteria Bioanalysis[Journal]


Perspectives on gender parity in bioanalysis: an interview with Atreyee Sims.

Authors:
Atreyee Sims

Bioanalysis 2019 Apr 18. Epub 2019 Apr 18.

PRA Health Sciences, 11070 Strang Line Road, Lenexa, KS 66215, USA.

Biography Atreyee Sims is an accomplished and committed GCP/GLP trained Project Manager overseeing Phase I-III clinical trials with a strong scientific acumen in pharmacology, microbiology and molecular biology. Project delivery emboldened by 10 years' experience as a Clinical Laboratory Scientist and Microbiologist with more than ten published peer-reviewed manuscripts. Spearheads project leadership role in GCP/GLP and protocol-compliant tracking of project results, implements data collection procedures and verifies project data to ensure timely delivery with the highest priority of both subject safety and data integrity. Read More

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https://www.future-science.com/doi/10.4155/bio-2019-0054
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http://dx.doi.org/10.4155/bio-2019-0054DOI Listing
April 2019
1 Read

Perspectives on gender parity in bioanalysis: an interview with Lauren Stevenson.

Bioanalysis 2019 Apr 18. Epub 2019 Apr 18.

Development Biomarkers and Bioanalytical Sciences, Biogen, Cambridge, MA 02142, USA.

Biography Lauren is Senior Director, Development Biomarkers & Bioanalytical Sciences at Biogen, Cambridge, MA, USA where she leads a team of talented scientists, setting bioanalytical and biomarker strategies and developing pharmacokinetics (PK), immunogenicity and biomarker assays in support of programs at all stages of development, from discovery to post-marketing. Lauren's team currently supports over 40 therapeutic programs, delivering PK and immunogenicity strategy and execution for Biogen's large molecule, antisense oligonucleotide (ASO0 and gene therapy portfolio as well as developing biomarkers in support of multiple sclerosis, immunology, fibrosis, rare and neurodegenerative disease indications. Externally, Lauren engages the broader industry and regulatory agencies as an invited speaker and course instructor at multiple conferences and workshops each year. Read More

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https://www.future-science.com/doi/10.4155/bio-2019-0060
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http://dx.doi.org/10.4155/bio-2019-0060DOI Listing
April 2019
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Development and validation of indirect and generic immunoassays to quantify free and total evolocumab in rat serum.

Bioanalysis 2019 Apr 18. Epub 2019 Apr 18.

Key Laboratory of Molecular Pharmacology & Drug Evaluation, School of Pharmacy, Yantai University, Ministry of Education, Collaborative Innovation Center of Advanced Drug Delivery System & Biotech Drugs in Universities of Shandong, Yantai University, Yantai 264005, PR China.

Evolocumab is a human monoclonal antibody used in the treatment of cardiovascular diseases, which targeted proprotein convertase subtilisin kexin type 9. To accurately quantify free (including partially bound) and total evolocumab concentrations in serum, indirect and generic ELISA methods were developed and validated in rat serum. Indirect ELISA was accurate and precise over the concentration range of 23. Read More

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http://dx.doi.org/10.4155/bio-2019-0003DOI Listing

Perspectives on gender parity in bioanalysis: an interview with Shane Needham.

Authors:
Shane Needham

Bioanalysis 2019 Apr 18. Epub 2019 Apr 18.

Alturas Analytics, Inc., 1324 Alturas Drive, Moscow, ID 83843, USA.

Dr Shane Needham received his BS degree in chemistry from Washington State University and his PhD in chemistry from the University of Rhode Island. Dr Needham is Co-Founder and Chief Scientific Officer of Alturas Analytics, Inc. Dr Needham manages all scientific aspects of the HPLC/MS/MS bioanalytical contract laboratory at Alturas Analytics, Inc. Read More

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https://www.future-science.com/doi/10.4155/bio-2019-0058
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http://dx.doi.org/10.4155/bio-2019-0058DOI Listing
April 2019
1 Read

Perspectives on gender parity in bioanalysis: an interview with Katryn Allen.

Authors:
Katryn Allen

Bioanalysis 2019 Apr 18. Epub 2019 Apr 18.

PRA Health Sciences Bioanalytical Laboratory, 11070 Strang Line Rd, Lenexa, KS 66215, USA.

Katryn Allen is currently a method development scientist at the PRA Health Sciences Bioanalytical Laboratory in Lenexa, Kansas. Katryn has over 5 years of pharmaceutical industry experience in bioanalytical method development and in the preclinical environment. While at PRA, she has developed ligand-binding assays for pharmacokinetic, pharmacodynamics and immunogenicity end points. Read More

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https://www.future-science.com/doi/10.4155/bio-2019-0053
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http://dx.doi.org/10.4155/bio-2019-0053DOI Listing
April 2019
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Perspectives on gender parity in STEM/Bioanalysis: an interview with Binodh DeSilva.

Authors:
Binodh De Silva

Bioanalysis 2019 Apr 18. Epub 2019 Apr 18.

Head, Analytical Strategy & Operations, Bristol-Myers Squibb, New Brunswick, NJ 08903, USA.

Biography Binodh DeSilva, PhD Vice President Analytical Strategy & Operations at Bristol-Myer Squibb (BMS) Company in New Brunswick, NJ, USA. She is responsible for leading the regulated analytical (small and large molecule), microbiology and industrial hygiene laboratories as well as the Chemistry, Manufacturing & Controls (CMC) regulatory document management functions in Product Development. She received her Bachelor's in Analytical Chemistry from the University of Colombo, Sri Lanka in 1987, and a PhD in Chemistry (Bioanalytical) in 1994 from the University of Kansas. Read More

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https://www.future-science.com/doi/10.4155/bio-2019-0068
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April 2019
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Perspectives on gender parity in Bioanalysis: an interview with Scott Summerfield.

Bioanalysis 2019 Apr 18. Epub 2019 Apr 18.

Department of Bioanalysis, Immunogenicity & Biomarkers, GlaxoSmithKline R&D, Park Road, Ware, SG12 0DP, UK.

Biography Having studied for a PhD and postdoctoral fellowship in proteomics Scott moved into the field of regulated Bioanalysis in 1997 when joining SmithKline Beecham. In 2001, Scott moved to Neuroscience Drug Discovery to lead a bioanalytical team supporting PK, DMPK and metabolite id work. In 2009, he returned to the regulated bioanalytical group, initially as a Section Leader and subsequently as Site Head and currently as WW Head of Bioanalysis at GSK. Read More

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https://www.future-science.com/doi/10.4155/bio-2019-0073
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http://dx.doi.org/10.4155/bio-2019-0073DOI Listing
April 2019
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Perspectives on gender parity in bioanalysis: an interview with Chad Briscoe.

Authors:
Chad Briscoe

Bioanalysis 2019 Apr 18. Epub 2019 Apr 18.

PRA Health Sciences, 11070 Strang Line Road, Lenexa, KS 66215, USA.

Biography Chad received his Bachelor of Science degree in Chemistry from Alma College in Michigan and a Master's degree in Analytical Chemistry from the University of Michigan with a focus in the use of LC-MS/MS in protein and peptide analysis. Chad's Doctorate of Philosophy at the University of Nebraska was focused on studies of protein binding via affinity LC-MS/MS and computer simulations. Chad's career of nearly 25 years includes positions of increasing responsibility ranging from bench scientist to his current role as global head of scientific affairs for Bioanalytical Science at PRA. Read More

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https://www.future-science.com/doi/10.4155/bio-2019-0055
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April 2019
1 Read

Perspectives on gender parity in bioanalysis: an interview with Nikunj Tanna.

Authors:
Nikunj Tanna

Bioanalysis 2019 Apr 18. Epub 2019 Apr 18.

Scientific Operations, Waters Corporation, Milford, MA 01757, USA.

Biography Nikunj Tanna is a senior scientist in the Scientific Operations department at Waters Corporation, focusing on quantification of small and large molecules for pharmaceutical, biopharmaceutical and clinical diagnostics applications. He previously led the clinical diagnostics team at Berg LLC, a Framingham, MA-based biotech and clinical stage company. He feeds his curiosity with nuanced conversations with people from all walks of life. Read More

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https://www.future-science.com/doi/10.4155/bio-2019-0061
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http://dx.doi.org/10.4155/bio-2019-0061DOI Listing
April 2019
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Perspectives on gender parity in Bioanalysis: an interview with Shefali Patel.

Authors:
Shefali R Patel

Bioanalysis 2019 Apr 18. Epub 2019 Apr 18.

Janssen R&D, 1400 Mckean road, Springhouse, PA 19477, USA.

Biography Shefali R Patel is a Senior Scientist and a Group leader in the Bioanalytical Group within DMPK Department at Janssen (a Johnson & Johnson company). In her current role, she is supervising the nonregulated bioanalysis group within East Coast Bioanalytical Department. Also, as a part of her current role, she is applying microsampling techniques for rodent studies within Johnson & Johnson. Read More

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https://www.future-science.com/doi/10.4155/bio-2019-0059
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http://dx.doi.org/10.4155/bio-2019-0059DOI Listing
April 2019
1 Read

Perspectives on gender parity in bioanalysis: an interview with Stephanie Cape.

Authors:
Stephanie Cape

Bioanalysis 2019 Apr 18. Epub 2019 Apr 18.

Bioanalytical Chemistry, Covance Laboratories, 3301 Kinsman Blvd., Madison, WI 53704, USA.

Stephanie Cape, is the Director of Bioanalytical Science at Covance, Madison, WI, USA. She received her BS in Chemistry from University of IL- Urbana/Champaign in 2003 and her PhD in Analytical Chemistry from the University of Wisconsin - Madison in 2007. Dr Cape's graduate research was focused on developing high-resolution mass spectrometric methods to enable discovery, characterization, imaging and quantitation of neuropeptides. Read More

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http://dx.doi.org/10.4155/bio-2019-0056DOI Listing

Perspectives on gender parity in bioanalysis: an interview with Michael R Borenstein.

Bioanalysis 2019 Apr 18. Epub 2019 Apr 18.

School of Pharmacy, Department of Pharmaceutical Sciences, Temple University, 3307 N Broad St, Philadelphia, PA 19140, USA.

Biography MR Borenstein is Senior Associate Dean of Operations for Temple University School of Pharmacy, Associate Professor of Medicinal Chemistry, Director of the Office of Continuing Professional Education and Director of the Admissions Committee for the PharmD program. He formally served as Chair of the Department of Pharmaceutical Sciences. He is a registered pharmacist licensed to practice in Pennsylvania. Read More

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https://www.future-science.com/doi/10.4155/bio-2019-0066
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http://dx.doi.org/10.4155/bio-2019-0066DOI Listing
April 2019
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Bioanalysis - but not as we knew it: an AstraZeneca perspective of the last 10 years evolution to meet a diversifying portfolio.

Bioanalysis 2019 Apr 18. Epub 2019 Apr 18.

Translational Biomarkers & Bioanalysis, Drug Safety & Metabolism, IMED Biotech Unit, AstraZeneca, Cambridge, UK.

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http://dx.doi.org/10.4155/bio-2019-0037DOI Listing

Feasibility of measuring sodium, potassium and creatinine from urine sample on dried filter paper.

Bioanalysis 2019 Apr 17. Epub 2019 Apr 17.

Centre for Community Medicine, All India Institute of Medical Sciences, New Delhi, India.

To develop a bioassay for estimation of sodium, potassium and creatinine in dried urine strips and comparing with their respective concentration in liquid urine samples. Urine was collected on filter paper strips, dried at room temperature and, eluted for estimation of sodium, potassium by indirect ion selective electrode method and creatinine by Jaffé method. This bioassay was validated based on the US FDA guidelines for bioanalytical method validation and was linear, sensitive, accurate and precise with acceptable recovery and matrix effects. Read More

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https://www.future-science.com/doi/10.4155/bio-2018-0295
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http://dx.doi.org/10.4155/bio-2018-0295DOI Listing
April 2019
1 Read
3.003 Impact Factor

Distribution of heparan sulfate and dermatan sulfate in mucopolysaccharidosis type II mouse tissues pre- and post-enzyme replacement therapy determined by UPLC-MS/MS.

Bioanalysis 2019 Apr 17. Epub 2019 Apr 17.

Department of Pediatrics, Division of Medical Genetics, Faculty of Medicine & Health Sciences, Université de Sherbrooke, CR-CHUS, Hospital Fleurimont, 3001, 12th Avenue North, Sherbrooke, QC, J1H 5N4, Canada.

Mucopolysaccharidosis type II (MPS II) is a lysosomal storage disorder caused by a deficiency of the iduronate-2-sulfatase enzyme leading to the accumulation of heparan sulfate (HS) and dermatan sulfate (DS) in organs and biological fluids. Enzyme replacement therapy is available for affected patients. A 6-min UPLC-MS/MS method was developed/validated for HS and DS quantification in mouse tissues and biological fluids with high accuracy and precision. Read More

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http://dx.doi.org/10.4155/bio-2018-0306DOI Listing
April 2019
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Multiplexed immunoassay approach to characterize antidrug antibody like specific reactivity.

Bioanalysis 2019 Apr 17. Epub 2019 Apr 17.

Pfizer, 1 Burtt Rd, Andover, MA 01810, USA.

Characterization of antidrug antibody (ADA) like reactivity has emerged as critical element of bioanalytical design and assessment of compound immunogenicity risk. Multiplex immunoassay was applied to detect and characterize ADA like reactivity using Photonic Ring Immunoassay platform (Genalyte). Specific binding to human IgE or human recombinant IL21-receptor-Fc fusion using exogenous reagents as surrogates for drug specific reactivity was investigated. Read More

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https://www.future-science.com/doi/10.4155/bio-2018-0072
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April 2019
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Stability studies of rifampicin in plasma and urine of tuberculosis patients according to the European Medicines Agency Guidelines.

Bioanalysis 2019 Apr 17. Epub 2019 Apr 17.

Medical Officer, Dr Harisingh Gour Vishwavidyalaya (A Central University), Sagar, Madhya Pradesh, India.

The macrolide antibiotic rifampicin is prescribed against several infections, like tuberculosis disease. This drug decays to rifampicin quinone. The biological fluids were diluted in a micellar solution and directly injected. Read More

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http://dx.doi.org/10.4155/bio-2018-0174DOI Listing

Determination of BPI15086 and its metabolite in human plasma by ultra-high performance liquid chromatography-MS/MS and its application to a pharmacokinetic study.

Bioanalysis 2019 Apr 17. Epub 2019 Apr 17.

Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100032, PR China.

BPI15086 is a potent, irreversible mutant-selective inhibitor of both EGFR (EGFR tyrosine kinase inhibitor) and the T790M resistance mutations tyrosine kinase. A simultaneous quantification method of BPI15086 and its main metabolite in human plasma using LC-MS/MS is documented and fully validated in this study. Plasma samples were extracted and chromatographed on an Acquity ultra-high performance liquid chromatography BEH C18 column with a gradient elution. Read More

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https://www.future-science.com/doi/10.4155/bio-2018-0307
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http://dx.doi.org/10.4155/bio-2018-0307DOI Listing
April 2019
1 Read

Critical reagent screening and characterization: benefits and approaches for protein biomarker assays by hybrid LC-MS.

Bioanalysis 2019 Apr 17. Epub 2019 Apr 17.

Bioanalytical Sciences, Bristol-Myers Squibb Company, Princeton, NJ 08543, USA.

In recent years, hybrid ligand-binding assays (LBAs)/LC-MS assays have been increasingly used for quantitation of protein biomarkers in biological matrices. However, unlike in LBAs where the importance of critical reagent screening and characterization is well understood and widely reported, benefits of well-characterized hybrid LC-MS assay reagents are frequently underestimated. Two groups of analyte-specific reagents, binding reagents and assay calibrators, are considered the critical reagents for biomarker assays. Read More

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http://dx.doi.org/10.4155/bio-2018-0277DOI Listing
April 2019
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3.003 Impact Factor

Regulatory perspective of biomarker bioanalysis during drug development.

Bioanalysis 2019 Apr 17. Epub 2019 Apr 17.

Office of Clinical Pharmacology, Office of Translational Sciences (OTS), Center for Drug Evaluation & Research (CDER), US Food & Drug Administration, 10903 New Hampshire Avenue, Building 51, Room 2130, Silver Spring, MD 20993, USA.

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https://www.future-science.com/doi/10.4155/bio-2019-0029
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April 2019
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The 10-year bioanalysis challenge in Mexico.

Bioanalysis 2019 Apr 17. Epub 2019 Apr 17.

Pharmometrica. Av. de las Granjas 972, Edif. "C" planta baja - Tecnoparque Azcapotzalco, Col. Santa Bárbara, 02230 Ciudad de México (CDMX), Mexico.

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http://dx.doi.org/10.4155/bio-2019-0020DOI Listing

Reflecting on with the Senior Editors.

Authors:
Howard M Hill

Bioanalysis 2019 Apr 17. Epub 2019 Apr 17.

ResolvPharma, North Yorkshire, UK.

A previous Senior Editor, and the present Senior Editor of reflect on their journeys in the field of bioanalysis, and with the journal. They discuss the evolution and progress of journal since its launch 10 years ago, and where they would like to see it heading in the future. Read More

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http://dx.doi.org/10.4155/bio-2019-0071DOI Listing
April 2019
3.003 Impact Factor

Quantification below the LLOQ in regulated LC-MS/MS assays: a review of bioanalytical considerations and cautions.

Authors:
Jeffrey X Duggan

Bioanalysis 2019 Apr 17. Epub 2019 Apr 17.

JXD Bioanalytics, 159 Lakemere Drive, Southbury, CT 06488, USA.

In response to an earlier workshop covering the pros and cons of quantification below the LLOQ (BLQ) the author reviews the topics discussed from the bioanalytical standpoint. Important considerations for estimating concentrations below the LLOQ include: method signal-to-noise, baseline shape and condition, close lying interference peaks (especially for protein methods), matrix effect, adsorption and stability of the analyte at low concentrations and carryover. These methodological issues are discussed as possible contributors to inaccuracy in BLQ estimations, and appropriate cautions are provided via examples. Read More

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http://dx.doi.org/10.4155/bio-2018-0261DOI Listing

Electromembrane extraction with solvent modification of the acceptor solution: improved mass transfer of drugs of abuse from human plasma.

Bioanalysis 2019 Apr 17. Epub 2019 Apr 17.

Department of Pharmacy, University of Oslo, PO Box 1068, Blindern, 0316 Oslo, Norway.

Electromembrane extraction (EME) of 37 drugs of abuse with significant differences in terms of polarity (0.68 < log P < 4.3) and basicity (1. Read More

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http://dx.doi.org/10.4155/bio-2018-0308DOI Listing

Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for Bioanalysis.

Bioanalysis 2019 Apr 17. Epub 2019 Apr 17.

WuXi Apptec, Plainsboro, NJ, USA.

Over the last decade, the use of biomarker data has become integral to drug development. Biomarkers are not only utilized for internal decision-making by sponsors; they are increasingly utilized to make critical decisions for drug safety and efficacy. As the regulatory agencies are routinely making decisions based on biomarker data, there has been significant scrutiny on the validation of biomarker methods. Read More

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http://dx.doi.org/10.4155/bio-2019-0072DOI Listing
April 2019
3.003 Impact Factor

A rapid derivatization based LC-MS/MS method for quantitation of short chain fatty acids in human plasma and urine.

Bioanalysis 2019 Apr 17. Epub 2019 Apr 17.

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

Objective of this study is to develop a robust multi-matrix LC-MS/MS for the quantitation of endogenous short chain fatty acids (SCFA) biomarkers in human plasma and urine. Developed method utilizes stable isotope-labeled internal standards, high-throughput derivatization procedure for sample preparation and LC-MS/MS analysis using multiple reaction monitoring transitions in positive electrospray ionization mode. Surrogate matrix method was used for quantitation. Read More

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http://dx.doi.org/10.4155/bio-2018-0241DOI Listing

Protein quantification by LC-MS: a decade of progress on the pages of Bioanalysis.

Bioanalysis 2019 Apr 15. Epub 2019 Apr 15.

Bioanalytical Laboratory, PRA Health Sciences, Amerikaweg 18, 9407 TK, Assen, The Netherlands.

Over the past 10 years, there has been a remarkable increase in the use of LC-MS for the quantitative determination of proteins, and this technique can now be considered an established bioanalytical platform for the quantification of macromolecular drugs and biomarkers, next to the traditional ligand-binding assays. Many researchers have contributed to the field and helped improve both the technical possibilities of LC-MS-based workflows and our understanding of the meaning of the results that are obtained. As a tribute to Bioanalysis, which has published many important contributions, this report gives a high-level overview of the most important trends in the field of protein LC-MS, as published in this journal since its inauguration a decade ago. Read More

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https://www.future-science.com/doi/10.4155/bio-2019-0032
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April 2019
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Bioanalytical method validation guidance language and a decade of progress.

Bioanalysis 2019 Apr 15. Epub 2019 Apr 15.

Bioanalytical & ADME Laboratories, Q Squared Solutions, 19 Brown Road, Ithaca, NY 14850, USA.

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http://dx.doi.org/10.4155/bio-2019-0051DOI Listing

New insights on critical reagent optimization for antidrug antibody assays.

Bioanalysis 2019 Apr 12. Epub 2019 Apr 12.

Syneos Health, 301D College Road East, Princeton, NJ 08540, USA.

Aim: Conjugated critical reagents are a pillar of ligand binding analysis. Although good practices for characterization have already been discussed, little is known about how assays are affected by specific conjugation parameters.

Results: Here we developed, characterized and screened a toolset of bioconjugates that provided new insights about the optimization of conjugated critical reagent attributes. Read More

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https://www.future-science.com/doi/10.4155/bio-2019-0040
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April 2019
4 Reads

Feedback from the European Bioanalysis Forum liquid microsampling consortium: microsampling: assessing accuracy and precision of handheld pipettes and capillaries.

Bioanalysis 2019 Apr 11. Epub 2019 Apr 11.

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

Aim: Microsampling in preclinical pharmacokinetics (PK) studies is currently widely adopted across the pharmaceutical industry.

Materials & Methods: The European Bioanalysis Forum liquid microsampling consortium member companies assessed the accuracy and precision of handheld pipettes and microcapillaries at volumes of less than 10 μl. The following key factors on pipetting performance were also evaluated: Pipette type (positive displacement, air displacement and microcapillary), experience of user and the liquid type. Read More

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http://dx.doi.org/10.4155/bio-2019-0018DOI Listing

Feedback from the European Bioanalysis Forum liquid microsampling consortium: capillary liquid microsampling and assessment of homogeneity of the resultant samples.

Bioanalysis 2019 Apr 11. Epub 2019 Apr 11.

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

Following the completion of a detailed experimental protocol into the potential inhomogeneity of capillary liquid microsamples, which was performed at seven European Bioanalysis Forum member companies, the summary and conclusion on the data are reported here. It has been demonstrated that it is possible to generate homogeneous samples using these microsampling techniques; that the resultant microsamples can be accurate and precise and that capillary liquid microsampling data can be consistent with conventional larger volume plasma samples. However, the data contain some variability which is contributed to by the different range of experiences that each investigating site had with these techniques. Read More

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http://dx.doi.org/10.4155/bio-2019-0017DOI Listing

Microsampling for quantitative bioanalysis, an industry update: output from an AAPS/EBF survey.

Bioanalysis 2019 Apr 11. Epub 2019 Apr 11.

Lilly Research Laboratories, Eli Lilly & Company, Indianapolis, IN 46285, USA.

There is continuing interest in the development and application of various microsampling technologies for drug development. The AAPS bioanalytical community microsampling subgroup and the European Bioanalysis Forum conducted a survey of their members (39 individual organizations). This gives a snapshot of current practices and demonstrates that implementation of microsampling approaches is becoming increasingly commonplace, but not universal. Read More

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https://www.future-science.com/doi/10.4155/bio-2019-0019
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April 2019
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Evolving our thinking on biomarker assay validation: are we ready for the next leap?

Bioanalysis 2019 Apr 9. Epub 2019 Apr 9.

Development Biomarkers & Bioanalytical Sciences, Biogen, 225 Binney Street, Cambridge, MA 02142, USA.

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http://dx.doi.org/10.4155/bio-2019-0008DOI Listing

Bioanalysis: 10 years of progress.

Authors:
Neil Spooner

Bioanalysis 2019 Apr 4. Epub 2019 Apr 4.

Spooner Bioanalytical Solutions Ltd, Hertford, SG138BQ, UK.

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http://dx.doi.org/10.4155/bio-2019-0070DOI Listing
April 2019
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Assessing stability in bioanalysis: reflections on the last 10 years.

Authors:
Chad Briscoe

Bioanalysis 2019 Apr 4. Epub 2019 Apr 4.

Bioanalytical Sciences, PRA Health Sciences, 11070 Strangline Road, Lenexa, KS 66215, USA.

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http://dx.doi.org/10.4155/bio-2019-0043DOI Listing

Instrumental and technical evolution over the past decade in bioanalysis.

Authors:
Robert MacNeill

Bioanalysis 2019 Apr 4. Epub 2019 Apr 4.

Department of Bioanalysis, Envigo, Mettlers Road, East Millstone, NJ 08875-2360, USA.

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http://dx.doi.org/10.4155/bio-2018-0327DOI Listing

The Japan Bioanalysis Forum: the past 8 years and future perspective.

Bioanalysis 2019 Apr 4. Epub 2019 Apr 4.

Pfizer R&D Japan G.K, 3-22-7 Yoyogi, Shibuya-ku, Tokyo 151-8589, Japan.

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http://dx.doi.org/10.4155/bio-2019-0047DOI Listing

Celebrating the collaboration of Bioanalysis and Bioanalysis Zone.

Authors:
Naamah Maundrell

Bioanalysis 2019 Apr 4. Epub 2019 Apr 4.

Future Science Group, Unitec House, 2 Albert Place, London N3 1QB, UK.

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http://dx.doi.org/10.4155/bio-2019-0038DOI Listing

Looking beyond the WRIB Decennial Index of the White Papers in .

Bioanalysis 2019 Apr 4. Epub 2019 Apr 4.

CFABS, Montreal, QC, Canada.

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http://dx.doi.org/10.4155/bio-2019-0050DOI Listing
April 2019
1 Read
3.003 Impact Factor

New development of the Chinese bioanalytical landscape and update of the China Bioanalysis Forum.

Bioanalysis 2019 Apr 4. Epub 2019 Apr 4.

Center for DMPK Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, No. 501 Haike Rd, Zhangjiang Hi Tech Park, Shanghai 201203, PR China.

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http://dx.doi.org/10.4155/bio-2019-0010DOI Listing

Celebrating 10 years of publishing Bioanalysis.

Authors:
Laura Dormer

Bioanalysis 2019 Apr 4. Epub 2019 Apr 4.

Future Science Group, Unitec House, London, N3 1QB, UK.

It has been a great pleasure to watch the development of Bioanalysis from its launch in 2009 to its current place as a leading journal in the field of regulated quantitative bioanalysis. There have been many changes in the publishing landscape since the journal first began, and it is satisfying to see how the journal has evolved during that time, currently under the excellent guidance of Managing Editor Sankeetha Nadarajah. In this brief article, I will look back over developments at the journal, and in the wider publishing industry, over the past decade. Read More

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http://dx.doi.org/10.4155/bio-2019-0049DOI Listing

Elucidation of the statistical factors that influence anti-drug antibody cut point setting through a multi-laboratory study.

Bioanalysis 2019 Apr 4. Epub 2019 Apr 4.

National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kawasaki, Kanagawa 210-9501, Japan.

Aim: Appropriateness of anti-drug antibody (ADA) assay is critical for immunogenicity assessment of biopharmaceuticals. Although cut point setting in ADA assay has a large impact on the results, a standard statistical approach for its setting has not been well established.

Methodology: In this multi-laboratory study, to elucidate factors influencing the cut point setting, we compared the statistical approaches and calculated cut points for multiple datasets of ADA assays using the individual procedure employed at each laboratory. Read More

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http://dx.doi.org/10.4155/bio-2018-0178DOI Listing

Regulatory efforts in response to a decade of scientific advancement in bioanalytical methods.

Authors:
Sam H Haidar

Bioanalysis 2019 Apr 4. Epub 2019 Apr 4.

US Food & Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA.

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http://dx.doi.org/10.4155/bio-2019-0034DOI Listing
April 2019
2 Reads

A note from the European Bioanalysis Forum.

Authors:
Philip Timmerman

Bioanalysis 2019 Apr 4. Epub 2019 Apr 4.

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

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http://dx.doi.org/10.4155/bio-2019-0046DOI Listing

A volumetric absorptive microsampling LC-MS/MS method for five immunosuppressants and their hematocrit effects.

Bioanalysis 2019 Mar 20. Epub 2019 Mar 20.

Department of Clinical Pharmacy & Pharmacology, University of Groningen, University Medical Center Groningen,  Groningen, The Netherlands.

Aim: The aim of this study was to develop and validate a LC-MS/MS assay for tacrolimus, sirolimus, everolimus, cyclosporin A and mycophenolic acid using volumetric absorptive microsampling tips as a sampling device and to investigate the effect on the recoveries of the analyte concentration in combination with the hematocrit (HT), which included temsirolimus (a structural analog).

Results: The maximum observed overall bias was 9.6% for the sirolimus LLOQ, while the maximum overall coefficient of variation was 8. Read More

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https://www.future-science.com/doi/10.4155/bio-2018-0312
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http://dx.doi.org/10.4155/bio-2018-0312DOI Listing
March 2019
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Anti-VEGF drug interference with VEGF quantitation in the R&D systems human quantikine VEGF ELISA kit.

Bioanalysis 2019 Mar 20;11(5):381-392. Epub 2019 Mar 20.

Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591, USA.

Aim: To evaluate the accuracy of the Quantikine Human VEGF Immunoassay (R&D Systems) in the presence of VEGF inhibitors.

Materials & Methods: Quantikine VEGF ELISA (R&D), anti-VEGF mAb (R&D), VEGF and aflibercept (Regeneron), ranibizumab and bevacizumab (Genentech).

Results: Binding affinity of anti-VEGF mAb for VEGF was threefold weaker than aflibercept, but 33- and 40-fold stronger than ranibizumab or bevacizumab. Read More

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http://dx.doi.org/10.4155/bio-2018-0096DOI Listing

An efficient and quantitative assay for epitope-tagged therapeutic protein development with a capillary western system.

Bioanalysis 2019 Mar 20. Epub 2019 Mar 20.

Division of Pharmacy Practice & Science, College of Pharmacy, The Ohio State University, Columbus, OH 43210, USA.

Aim: To develop and validate a reliable, robust and efficient assay to detect and quantify biologic compounds in vitro and in vivo during early stage of a biotherapeutic agent discovery. Methodology & results: An enrichment-free immunoassay method was developed to quantify a polyhistidine N- and FLAG C-terminally-tagged recombinant protein of ∼55 kDa. The target proteins were purified by a nickel-based matrix via tag affinity, followed by probing with biotinylated antitag antibody and subsequently detected by streptavidin-horseradish peroxidase conjugate using an automated capillary-based western system. Read More

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https://www.future-science.com/doi/10.4155/bio-2018-0248
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http://dx.doi.org/10.4155/bio-2018-0248DOI Listing
March 2019
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Identification of β-hydroxybutyrate as a potential biomarker for female papillary thyroid cancer.

Bioanalysis 2019 Mar 20. Epub 2019 Mar 20.

Quality Safety and Framework Convention on Tobacco Control Research Team, China National Tobacco Quality Supervision & Test Center, Zhengzhou 450001, Henan, PR China.

Aim: β-Hydroxybutyrate (BHB) was proved to be a differential metabolite of papillary thyroid cancer (PTC) by semiquantitative analysis, while whether BHB could be used as a potential biomarker for female PTC still needed to be validated.

Materials & Methods: An LC-MS/MS method with surrogate matrix was established to validate serum BHB in specified PTC patients.

Conclusion: Serum BHB levels in PTCs were significantly higher than those in HCs. Read More

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https://www.future-science.com/doi/10.4155/bio-2018-0273
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http://dx.doi.org/10.4155/bio-2018-0273DOI Listing
March 2019
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Simultaneous extraction and analysis of multiple cystine-dense peptides by μSPE and microflow-MS/MS from plasma.

Bioanalysis 2019 Mar 20. Epub 2019 Mar 20.

Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA 98109, USA.

Aim: Develop a universal extraction and liquid chromatography-mass spectrometer method to simultaneously analyze cystine-dense peptide (CDP) miniproteins from rat and human plasma. The results of the analysis will be used to assist selection of therapeutic drug candidates from the vast CDP library.

Methods & Results: A micro-elution solid-phase extraction method was developed for the sample preparation of the CDP peptides in rat and human plasma followed by analysis by microflow liquid chromatography MS/MS. Read More

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http://dx.doi.org/10.4155/bio-2018-0276DOI Listing

Development and validation of a quantitative ultra performance LC hydrophilic interaction liquid chromatography MS/MS method to measure fructose and sorbitol in human plasma.

Bioanalysis 2019 Mar 19;11(5):407-425. Epub 2019 Mar 19.

Clinical Biomarker Sciences Group, Precision Medicine, Early Clinical Development, Pfizer Inc., 610 Main Street, Cambridge, MA 02139, USA.

Aim: Fructose and sorbitol are utilized as biomarkers for nonalcoholic steatohepatitis. Measurement of fructose and sorbitol levels helps understanding disease progression, drug response and underlying mechanism.

Materials & Methods: Stable isotope-labeled fructose and sorbitol were used as surrogate standards and internal standards. Read More

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https://www.future-science.com/doi/10.4155/bio-2018-0286
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http://dx.doi.org/10.4155/bio-2018-0286DOI Listing
March 2019
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