DOCSLIB.ORG

Biopharmaceutical Services

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Biopharmaceutical Services INTERTEK PHARMACEUTICAL SERVICES BIOPHARMACEUTICAL SERVICES Expert Analytical & Bioanalytical Services INTERTEK BIOANALYSIS SERVICES Our Biopharmaceutical Expertise To meet your development milestones and comply with regulatory requirements, you will need high quality bioanalytical and analytical data to aid informed decision-making and identify sources of risk. Safety assessment is key, as slight changes in the structure, physicochemical properties, stability and impurity profile of a biologic can provoke an adverse immune response. Our thought-leaders have over 25 years Our biopharmaceutical services Our experience of experience in biopharmaceutical • GLP Clinical & Preclinical Bioanalysis • Recombinant Proteins & Glycoproteins development support across a wide range (PK, ADA, Nab) • Monoclonal Antibodies of product types. We provide regulatory- • Immunogenicity Studies led, phase-appropriate, tailored analytical • Antibody-Drug Conjugates program design with GLP / GCP / GMP • Analytical Programme Design • Biosimilars / Biobetters compliant laboratory services which • Structural Characterisation (ICH Q6B) • Peptides help you to navigate the challenges of • Physicochemical Properties (ICH Q6B) • Growth Factors development, regulatory submission, and • Biophysical Characterisation manufacturing. • Interferons • Comparability Studies With facilities located in India, Europe (UK, • Interleukins France, Switzerland) and the USA, our • Biosimilar Programmes • Vaccines strong scientific and technical leadership • Process Residuals Determination • Viral Vectors coupled with project management and • Product Related Impurities Determination • Oligonucleotide Therapeutics regulatory support, deliver a responsive, • Purity and Impurity Assessment flexible (bio)analytical resource, to drive your development and manufacturing • GMP Potency / Cell Based Assays programs forward. • Method Development & Validation • Extractables / Leachables • GMP Quality Control Testing • GMP Batch & Final Product Release Testing • ICH Stability Studies • Forced Degradation Studies • Drug Delivery / OINDP Expertise INTERTEK BIOPHARMACEUTICAL SERVICES To achieve a well- Protein Characterisation characterised biologic, Protein therapeutics can present significant analytical challenges. Our characterisation we apply a strategic packages are tailored to your biomolecule analytical program and reflect the requirements of ICH Guidelines to meet the analytical challenges that is tailored to your of a ‘well characterized’ or ‘specified’ molecule. biological product. Programs encompass many different analytical techniques and provide information ranging from evaluation of physicochemical properties and structural features including primary, secondary and higher order structure and assessment of post-translational modifications. Programs also include determination of biological potency and assessment of purity /impurity profiles. We continually invest in advanced analytical instrumentation which allows us to deliver data with the highest sensitivity, accuracy and resolution. Structural Characterisation Amino Acid Sequencing/ Sequencing studies and peptide mapping using a broad range of enzymatic or chemical digestion followed by Peptide Mapping: Mass Spectrometry (LC-MS/MS or MALDI-TOF MS). Amino acid composition: Pharmacopeia methods. Terminal amino acid Confirmation of N- and C-terminal sequences and evaluation of modifications and / or heterogeneity. sequence: Disulphide bridge Assessment of the degree and positions of both expected and mis-matched disulphide bridges by extended mapping: LC-MS/MS study and colorimetric test for free sulfhydryl groups. Glycosylation studies typically including levels of monosaccharides and sialic acid, N/O linked glycan profiling Carbohydrate structure: (NPLC, HILIC, IEX or CE-LIF), enzymatic digest and MALDI –TOF or LC-MS/MS. Physico-chemical Properties Molecular weight of intact proteins by MALDI-MS, ESI-MS and LC-MS supported by orthogonal techniques Molecular weight: such as MALLS and SDS-PAGE. Isoform pattern: Isoform and impurity studies using PAGE, SDS-PAGE, IEF, CE, HPLC. Extinction coefficient: Determination and Validated Extinction Coefficient studies. LC patterns: For ID, homogeneity, purity – HPLC, UPLC, SEC, RP HPLC, IEX, AEX. Spectroscopic patterns: CD, FTIR, 1D & 2D NMR, Fluorescence, UV-Visible. Electrophoretic patterns: CE(CZE), cIEF, CGE, SDS and NATIVE PAGE, Western Blot. Concentration: Lowry, BCA, Total AA, Total Nitrogen, Bradford. Aggregation studies: SEC (MALLS), DLS, Western Blot, CE, Gel Electrophoresis, SEM/TEM. Process Impurities: Residual host cell DNA by qPCR, Residuals (such as antibiotics, antifoaming agents). Potency Assays To support characterisation, stability, comparability testing and product release, for example, Complement- Cell-based Assays: dependent cytotoxicity (CDC), Antibody–dependent cell cytotoxicity (ADCC) and Neutralisation and Proliferation Assays. 3 Bioanalytical Expertise We apply our bioanalytical expertise and industry Large molecule bioanalysis Biomarker assays We have extensive experience in the We deliver discovery and clinical biomarker insight to design strategic development, validation, and sample analysis of solutions to support your precision medicine and efficient bioanalytical quantitative and qualitative Good Laboratory strategy enabling you to better predict Practice (GLP) and Good Clinical Practice (GCP) the long-term safety and efficacy of your programs immunochemistry and LC-MSMS expertise in products. Our dedicated biomarker team has support of pre-clinical and clinical development expertise in the qualification and validation programs in full regulatory compliance (FDA, of biomarkers using ELISA, and ECL platforms EMA and OECD GLP regulatory standards). (including multiplexing, prototypes and custom multiplexing and Luminex) in multiple matrices and anticoagulants. Our bioanalytical experts are highly experienced in developing and validating assays for • Quantitative Ligand Binding Assay pharmacokinetic (PK), toxicokinetic (TK), Capabilities pharmacodynamic (PD), immunogenicity, • Quantitative ELISAs for Proprietary efficacy and safety biomarker studies with Compounds diverse immunochemistry technologies, • Immunogenicity Studies radioimmunochemistry (RIA) and functional • Neutralization Cell-based Assay assay platforms. Development, Validation and Sample We offer comprehensive bioanalytical services Analysis to support complex products including proteins, • Radioimmunoassays (RIA), Enzymatic synthetic peptides, humanized monoclonal Assays antibodies, antibody drug conjugates, conjugated drugs, growth factors, hormones • Fluorometric Assays, Luminescence Assays and cytokines. Additionally, we offer industry • Biotinylations & Ruthenium Labeling unique capabilities, for example, quantitative, • Mode of Action Studies high resolution NMR which is an ideal tool for • Bioanalytical LC-MS/MS for Biologics bioanalysis of PEGylated moieties. • Affinity Interactions by SPR • NMR approaches for PEGylated Biomolecules • Biomarker Assays CASE STUDY Specialist Expertise Novel Approaches for An Enzyme Activity Assay Biosimilar services Monoclonal antibodies A client desired an activity assay for a Our biosimilar thought leaders apply a strategic Our experience spans recombinant monoclonal PEGylated enzyme for which a commercial approach to developing biosimilarity data antibodies and related products such as colorimetric assay was available. The with programs that provide highly relevant biosimilars, fusion proteins, Fab-fragments and colorimetric assay did not meet the early stage characterisation and late stage Fc fragments and antibody drug conjugates performance criteria for regulated work. An comparative data. These programs begin (ADCs) throughout the product lifecycle with immunoassay was then developed but was with extensive structural and functional a focus on monitoring relevant critical quality subject to significant matrix effects. characterization of both the proposed biosimilar attributes (CQAs), assessment of the impact of Our Solution product and the reference product and process changes on physicochemical properties Development of a replacement assay was evaluate and compare all pertinent features and structure, the presence of product-related complicated by endogenous substrate and of the biosimilar product and are based on the impurities or process-related impurities. enzymatic product.To overcome this, the criteria outlined in ICH Q6B. This analytical • Characterisation (Q6B) specificity of LC-MS/MS was employed and characterization serves as the foundation of • Primary Sequence Confirmation an activity assay developed using a stable a biosimilar development program. Programs (Peptide Map) labeled substrate which produced a labeled encompass many different analytical techniques product, which could be differentiated from and provide information ranging from evaluation • N/C terminal Sequence, Disulphide Bridge the endogenous analyte. of physiochemical properties and structural Mapping and PTMs Benefit Delivered to our Client features including primary, secondary and • Carbohydrate Structure A enzymatic activity LC-MS/MS assay was higher order structure and assessment of • Aggregation Studies post-translational modifications and cell-based developed and successfully validated to • Higher Order Structural Studies regulatory standards. The method was used assays to determination of biological potency • Aggregation Studies in multiple pharmacokinetic studies
Load more

Recommended publications
  • Raman Spectroscopic Characterization and Analysis of Agricultural and Biological Systems Qi Wang Iowa State University
    Iowa State University Capstones, Theses and Graduate Theses and Dissertations Dissertations 2013 Raman spectroscopic characterization and analysis of agricultural and biological systems Qi Wang Iowa State University Follow this and additional works at: https://lib.dr.iastate.edu/etd Part of the Agriculture Commons, Biomedical Commons, Bioresource and Agricultural Engineering Commons, and the Biostatistics Commons Recommended Citation Wang, Qi, "Raman spectroscopic characterization and analysis of agricultural and biological systems" (2013). Graduate Theses and Dissertations. 13019. https://lib.dr.iastate.edu/etd/13019 This Dissertation is brought to you for free and open access by the Iowa State University Capstones, Theses and Dissertations at Iowa State University Digital Repository. It has been accepted for inclusion in Graduate Theses and Dissertations by an authorized administrator of Iowa State University Digital Repository. For more information, please contact [email protected]. Raman spectroscopic characterization and analysis of agricultural and biological systems by Qi Wang A dissertation submitted to the graduate faculty in partial fulfillment of the requirements for the degree of DOCTOR OF PHILOSOPHY Major: Agricultural Engineering Program of Study Committee: Chenxu Yu, Major Professor Jacek Adam Koziel Kenneth J Koehler Lie Tang Sinisa Grozdanic Iowa State University Ames, Iowa 2013 Copyright © Qi Wang, 2013. All rights reserved. ii TABLE OF CONTENTS LIST OF FIGURES………………………………………………………………………………...…..v LIST OF TABLES.................................................................................................................................vi
    [Show full text]
  • Analytical Chemistry in the 21St Century: Challenges, Solutions, and Future Perspectives of Complex Matrices Quantitative Analyses in Biological/Clinical Field
    Review Analytical Chemistry in the 21st Century: Challenges, Solutions, and Future Perspectives of Complex Matrices Quantitative Analyses in Biological/Clinical Field 1, 2, 2, 3 Giuseppe Maria Merone y, Angela Tartaglia y, Marcello Locatelli * , Cristian D’Ovidio , Enrica Rosato 3, Ugo de Grazia 4 , Francesco Santavenere 5, Sandra Rossi 5 and Fabio Savini 5 1 Department of Neuroscience, Imaging and Clinical Sciences, University of Chieti–Pescara “G. d’Annunzio”, Via dei Vestini 31, 66100 Chieti, Italy; [email protected] 2 Department of Pharmacy, University of Chieti-Pescara “G. d’Annunzio”, Via Dei Vestini 31, 66100 Chieti (CH), Italy; [email protected] 3 Section of Legal Medicine, Department of Medicine and Aging Sciences, University of Chieti–Pescara “G. d’Annunzio”, 66100 Chieti, Italy; [email protected] (C.D.); [email protected] (E.R.) 4 Laboratory of Neurological Biochemistry and Neuropharmacology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Via Celoria 11, 20133 Milano, Italy; [email protected] 5 Pharmatoxicology Laboratory—Hospital “Santo Spirito”, Via Fonte Romana 8, 65124 Pescara, Italy; [email protected] (F.S.); [email protected] (S.R.); [email protected] (F.S.) * Correspondence: [email protected]; Tel.: +39-0871-3554590; Fax: +39-0871-3554911 These authors contributed equally to the work. y Received: 16 September 2020; Accepted: 16 October 2020; Published: 30 October 2020 Abstract: Nowadays, the challenges in analytical chemistry, and mostly in quantitative analysis, include the development and validation of new materials, strategies and procedures to meet the growing need for rapid, sensitive, selective and green methods.
    [Show full text]
  • Surface-Enhanced Raman Spectroscopy for Bioanalysis and Diagnosis
    Showcasing the Surface-enhanced Raman Spectroscopy (SERS) technique for Bioanalysis and Diagnosis As featured in: applications by a group of researchers led by Prof Liwu Volume 13 Number 27 21 July 2021 Zhang from Fudan University and Prof Ventsislav Valev Pages 11581-12046 from the University of Bath. Nanoscale rsc.li/nanoscale Surface-enhanced Raman spectroscopy for bioanalysis and diagnosis SERS is an eff ective analytical technique that has excellent potential in bioanalysis and diagnosis as demonstrated by its increasing applications in vivo . SERS fi nds a broad range of applications with clinical relevance, such as biological ISSN 2040-3372 PAPER Shifeng Zhao et al. The sign reversal of anomalous Hall eff ect derived from the transformation of scattering eff ect in cluster-assembled sensing, drug delivery, single cell assays, early stage cancer Ni 0.8 Fe 0.2 nanostructural fi lms screening and fast detection of pathogens. We present a comprehensive survey of SERS-based assays, from basic See Nicoleta E. Dina , Ventsislav K. considerations to bioanalytical applications. Valev, Liwu Zhang et al. , Nanoscale , 2021, 13 , 11593. rsc.li/nanoscale Registered charity number: 207890 Nanoscale View Article Online REVIEW View Journal | View Issue Surface-enhanced Raman spectroscopy for bioanalysis and diagnosis Cite this: Nanoscale, 2021, 13, 11593 Muhammad Ali Tahir,†a Nicoleta E. Dina, *†b Hanyun Cheng,a Ventsislav K. Valev *c and Liwu Zhang *a,d In recent years, bioanalytical surface-enhanced Raman spectroscopy (SERS) has blossomed into a fast- growing research area. Owing to its high sensitivity and outstanding multiplexing ability, SERS is an effective analytical technique that has excellent potential in bioanalysis and diagnosis, as demonstrated by its increasing applications in vivo.
    [Show full text]
  • Drug Metabolism, Pharmacokinetics and Bioanalysis
    Drug Metabolism, Pharmacokinetics and Bioanalysis Edited by Hye Suk Lee and Kwang-Hyeon Liu Printed Edition of the Special Issue Published in Pharmaceutics www.mdpi.com/journal/pharmaceutics Drug Metabolism, Pharmacokinetics and Bioanalysis Drug Metabolism, Pharmacokinetics and Bioanalysis Special Issue Editors Hye Suk Lee Kwang-Hyeon Liu MDPI • Basel • Beijing • Wuhan • Barcelona • Belgrade Special Issue Editors Hye Suk Lee Kwang-Hyeon Liu The Catholic University of Korea Kyungpook National University Korea Korea Editorial Office MDPI St. Alban-Anlage 66 4052 Basel, Switzerland This is a reprint of articles from the Special Issue published online in the open access journal Pharmaceutics (ISSN 1999-4923) in 2018 (available at: https://www.mdpi.com/journal/ pharmaceutics/special issues/dmpk and bioanalysis) For citation purposes, cite each article independently as indicated on the article page online and as indicated below: LastName, A.A.; LastName, B.B.; LastName, C.C. Article Title. Journal Name Year, Article Number, Page Range. ISBN 978-3-03897-916-6 (Pbk) ISBN 978-3-03897-917-3 (PDF) c 2019 by the authors. Articles in this book are Open Access and distributed under the Creative Commons Attribution (CC BY) license, which allows users to download, copy and build upon published articles, as long as the author and publisher are properly credited, which ensures maximum dissemination and a wider impact of our publications. The book as a whole is distributed by MDPI under the terms and conditions of the Creative Commons license CC BY-NC-ND. Contents About the Special Issue Editors ..................................... vii Preface to ”Drug Metabolism, Pharmacokinetics and Bioanalysis” ................. ix Fakhrossadat Emami, Alireza Vatanara, Eun Ji Park and Dong Hee Na Drying Technologies for the Stability and Bioavailability of Biopharmaceuticals Reprinted from: Pharmaceutics 2018, 10, 131, doi:10.3390/pharmaceutics10030131 ........
    [Show full text]
  • Bioanalysis Zone
    Powered by Bioanalysis TOP ARTICLE SUPPLEMENT CONTENTS REVIEW: Immunogenicity and PK/PD evaluation in biotherapeutic drug development: scientific considerations for bioanalytical methods and data analysis Bioanalysis Vol. 6 Issue 1 RESEARCH ARTICLE: An ultrasensitive method for the quantitation of active and inactive GLP-1 in human plasma via immunoaffinity LC-MS/MS Bioanalysis Vol. 6 Issue 1 REVIEW: Analytical protocols based on LC–MS, GC–MS and CE–MS for nontargeted metabolomics of biological tissues Bioanalysis Vol. 6 Issue 12 REVIEW Immunogenicity and PK/PD evaluation in biotherapeutic drug development: scientific considerations for bioanalytical methods and data ana lysis With the advent of novel technologies, considerable advances have been made in the evaluation of the relationship between PK and PD. Ligand-binding assays have been the primary assay format supporting PK and immunogenicity assessments. Critical and in-depth characterizations of the ligand-binding assay of interest can provide valuable understanding of the limitations, for interpreting PK/PD and immunogenicity results. This review illustrates key challenges with regard to understanding the relationship between anti-drug antibody and PK/PD, including confounding factors associated with the development and validation of ligand-binding assays, mechanisms by which anti-drug antibody impacts PK/PD, factors to consider during data analyses and interpretation, and a perspective on integrating immunogenicity data into the well-established quantitative modeling approach.
    [Show full text]
  • A Review on Liquid Chromatography-Tandem Mass Spectrometry Methods for Rapid Quantification of Oncology Drugs
    pharmaceutics Review A Review on Liquid Chromatography-Tandem Mass Spectrometry Methods for Rapid Quantification of Oncology Drugs Andrea Li-Ann Wong 1,2,†, Xiaoqiang Xiang 3,†, Pei Shi Ong 4, Ee Qin Ying Mitchell 4, Nicholas Syn 1,2, Ian Wee 1,2, Alan Prem Kumar 1,5 , Wei Peng Yong 1,2, Gautam Sethi 5, Boon Cher Goh 1,2,5,*, Paul Chi-Lui Ho 4,* and Lingzhi Wang 1,5,* 1 Cancer Science Institute of Singapore, National University of Singapore, Singapore 117599, Singapore; [email protected] (A.L.-A.W.); [email protected] (N.S.); [email protected] (I.W.); [email protected] (A.P.K.); [email protected] (W.P.Y.) 2 Department of Haematology-Oncology, National University Health System, Singapore 119228, Singapore 3 School of Pharmacy, Fudan University, Shanghai 201203, China; [email protected] 4 Department of Pharmacy, National University of Singapore, Singapore 117543, Singapore; [email protected] (P.S.O.); [email protected] (E.Q.Y.M.) 5 Department of Pharmacology, Yong Loo Lin School of Medicine, Singapore 117597, Singapore; [email protected] * Correspondence: [email protected] (B.C.G.); [email protected] (P.C.-L.H.); [email protected] (L.W.); Tel.: +65-6772-4140 (B.C.G.); +65-6516-2651 (P.C.-L.H.); +65-6516-8925 (L.W.); Fax: +65-68739664 (B.C.G. & L.W.); +65-6777-5545 (P.C.-L.H.) † Equal contribution. Received: 15 October 2018; Accepted: 5 November 2018; Published: 8 November 2018 Abstract: In the last decade, the tremendous improvement in the sensitivity and also affordability of liquid chromatography-tandem mass spectrometry (LC-MS/MS) has revolutionized its application in pharmaceutical analysis, resulting in widespread employment of LC-MS/MS in determining pharmaceutical compounds, including anticancer drugs in pharmaceutical research and also industries.
    [Show full text]
  • Review of Chromatographic Bioanalytical Assays for the Quantitative Determination of Marine-Derived Drugs for Cancer Treatment
    marine drugs Review Review of Chromatographic Bioanalytical Assays for the Quantitative Determination of Marine-Derived Drugs for Cancer Treatment Lotte van Andel 1,2,* ID , Hilde Rosing 1, Jan HM Schellens 2,3,4 and Jos H Beijnen 1,2,3 1 Department of Pharmacy & Pharmacology, Antoni van Leeuwenhoek, The Netherlands Cancer Institute and MC Slotervaart, 1066 CX Amsterdam, The Netherlands; [email protected] (H.R.); [email protected] (J.H.B.) 2 Division of Pharmacology, Antoni van Leeuwenhoek, The Netherlands Cancer Institute, 1066 CX Amsterdam, The Netherlands; [email protected] 3 Department of Clinical Pharmacology, Division of Medical Oncology, The Netherlands Cancer Institute, 1066 CX Amsterdam, The Netherlands 4 Department of Pharmaceutical Sciences, Faculty of Science, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, 3584 CG Utrecht, The Netherlands * Correspondence: [email protected]; Tel.: +31-20-512-9086 Received: 15 June 2018; Accepted: 18 July 2018; Published: 23 July 2018 Abstract: The discovery of marine-derived compounds for the treatment of cancer has seen a vast increase over the last few decades. Bioanalytical assays are pivotal for the quantification of drug levels in various matrices to construct pharmacokinetic profiles and to link drug concentrations to clinical outcomes. This review outlines the different analytical methods that have been described for marine-derived drugs in cancer treatment hitherto. It focuses on the major parts of the bioanalytical technology, including sample type, sample pre-treatment, separation, detection, and quantification. Keywords: marine-derived drugs; cancer; bioanalysis; chromatography 1. Introduction For years, researchers have roamed the seas and oceans in search of organisms possessing chemicals that could exhibit therapeutic effects.
    [Show full text]
  • Bioanalysis Solutions Life Inspired, Quality Driven
    LIFE SCIENCES BIOANALYSIS SOLUTIONS LIFE INSPIRED, QUALITY DRIVEN EXPERTISE TECHNOLOGY QUALITY YOUR GLOBAL DRUG DEVELOPMENT ORGANIZATION FOR BIOANALYTICAL TESTING With over 30 years of experience and operating out of our GLP/GCP compliant laboratories. SGS has the expertise to both develop assays from scratch (including LC-MS/MS, immunoassays and cell-based assays) and to support large scale routine sample analyses, from regulatory pre-clinical (toxicology) to early and late clinical studies (Phase I to IV). SERVICES CONTINUOUS FOCUS ON (cytokines/chemokines) in human DEVELOPMENT matrices, methods readily available for SGS Life Sciences can provide clinical sample analysis. bionanalytical testings for drug A dedicated group evaluates assay SGS provides a large list of development from regulatory preclinical requests from a strategic and scientific biomarkers. SGS doubled its to early and late clinical phases point of view. SGS offers more than capacity (lab space, equipment and 700 validated methods that are ready • Method transfer, development staff) within the last two years to for use with very short lead time. and validation for small molecules, develop multiplex immunoassays for biologics, biosimilars and Validation criteria follow guidelines biomarkers screening by therapeutic biomarkers. from FDA area (Mesoscale, Luminex 200 • PK bioanalysis (small molecules, • 2018: Bioanalytical method validation platforms). SGS also invested in the biologics, biosimilars) & 2019: Immunogenicity COBAS®6000 platform for biomarkers • PD bioanalysis
    [Show full text]
  • Issues Facing the Bioanalytical Community
    Bioanalysis Zone ISSUES FACING THE BIOANALYTICAL COMMUNITY Issues Facing The Bioanalytical Community: Highlights From The Bioanalysis Zone Round Table Discussion FOREWORD Dear colleague, It is my pleasure to welcome you to this special Bioanalysis Zone interactive supplement, which has been created to bring you the highlights from our recent Bioanalysis Zone Round Table Discussion on Issues Facing the Bioanalytical Community. Bioanalysis Zone and Bioanalysis organized an independent Roundtable Discussion on 20 April 2016 at Hilton Orlando Lake Buena Vista, Orlando, Florida, USA, in which bioanalytical experts from Pharmaceutical Companies (Pharma) and Contract Research Organizations (CROs) were brought together to discuss topical issues faced by the quantitative bioanalytical community. Chaired by Neil Spooner (Senior Editor, Bioanalysis), the discussion 2 focused on three key areas. First, the panellists assessed the current situation of outsourcing in bioanalysis, and discussed the direction of outsourcing of regulated bioanalysis in the future. Next, discussions on the divide between investments being made by Pharma and CROs in new bioanalytical techniques and technologies were discussed. Finally, the growing skills gap in bioanalytical laboratories was discussed covering aspects such as: the reality of the skills gap; technical areas is which the skills gap is most apparent; where the skills gap occurs; and how can it be overcome. Having been part of the organizing team, witnessing the discussion unfold was highly informative. It helped my understanding of the depth of issues facing the bioanalytical community and future opportunities to overcome these issues. I am therefore delighted to be able to share this free supplement where you will find highlights from the resulting Round Table Discussion Report published in Bioanalysis and links to footage of the discussion, hosted on Bioanalysis Zone.
    [Show full text]
  • Quantitative Bioanalysis of Intact Large Molecules Using Mass Spectrometry
    Journal of Applied Bioanalysis openaccess http://dx.doi.org/10.17145/jab.20.006 REVIEW Quantitative Bioanalysis of Intact Large Molecules using Mass Spectrometry Catherine E. DelGuidice1,2, Omnia A. Ismaiel2,3, William R. Mylott Jr2, Matthew S. Halquist1,* 1Department of Pharmaceutics, School of Pharmacy, Virginia Commonwealth University, Rich- mond, VA, USA. 2PPD Laboratories, Richmond, VA, USA. 3Department of Analytical Chemistry, Faculty of Pharmacy, Zagazig University, Egypt. *Correspondence: Department of Pharmaceutics, School of Pharmacy, Virginia Common- wealth University, Richmond, VA, USA. Phone: +1 804 827 2078. Email: [email protected] Citation: DelGuidice CE, Ismaiel OA, My- lott WR, Halquist MS. Quantitative Bioanalysis of Intact Large Molecules ABSTRACT using Mass Spectrometry. As biologic drugs become an increasing segment in the overall pharmaceuti- J Appl Bioanal 6(1), 52-64 (2020). cal market, it is important to develop accurate and reliable methods to analyze these drugs in biological matrices. With advancements in technology, biologics’ Editor: complex molecular structures can now be selectivity distinguished and quanti- Dr. Lin-zhi Chen, Boehringer Ingel- fied using high-resolution mass spectrometry and deconvolution software. Intact heim Pharmaceuticals, Ridgefield, (top-down) mass spectrometric techniques have been established as alternative CT 06877, USA. or complementary bioanalytical techniques for instances when ligand binding assays (LBAs) alone were not well suited, as it can provide additional structural
    [Show full text]
  • Online Bioanalytical Mass Spectrometry Methods for Analysis Of
    ONLINE BIOANALYTICAL MASS SPECTROMETRY METHODS FOR ANALYSIS OF SMALL AND LARGE BIOMOLECULES USING ONE- AND TWO-DIMENSIONAL LIQUID CHROMATOGRAPHY by Yehia Zakaria Baghdady DISSERTATION Submitted to the Graduate School of The University of Texas at Arlington in Partial Fulfillment of the Requirements for the Degree of DOCTOR OF PHILOSOPHY December 2018 Supervising Committee: Professor Kevin Schug, Chair Professor Daniel Armstrong Professor Krishnan Rajeshwar Associate Professor Kayunta Johnson-Winters Copyright © by Yehia Baghdady 2018 All Rights Reserved Acknowledgments Thank you is never enough to express how grateful I am to all who have supported me to reach this major stage of my life. Thanks to Allah, the most gracious and the most merciful, for surrounding me with those gorgeous people who have positive impact on my whole life starting with my research advisor, Dr. Kevin A. Schug. He trusted my capabilities, accepted me into his wonderful group and gave me the freedom to grow as a scientist and to try new ideas for all new challenges which I have faced in my research projects under his continuous guidance and support. I could not have imagined having a better mentor and research advisor for my Ph.D. degree. I would like to give special thanks to Dr. Armstrong, Dr. Rajeshwar and Dr. Johnson- Winters for being my committee members, their interest in my research, their invaluable suggestions and letting my defense be an enjoyable experience. I would also like to thank all our lab group members. I was very fortunate to be surrounded with smart and friendly lab mates. I would never forget to thank Restek Corporation for funding my research, providing their newest column technologies and providing me with an enriching industrial collaboration through their frequent visits and educational presentations.
    [Show full text]
  • Raman Spectroscopy of Algae: a Review Niranjan D T Parab and Vikas Tomar* School of Aeronautics and Astronautics, Purdue University, West Lafayette, USA
    dicine e & N om a n n a o t N e f c o h l n Journal of a o Parab and Tomar, J Nanomedic Nanotechnol 2012, 3:2 n l o r g u y o J DOI: 10.4172/2157-7439.1000131 ISSN: 2157-7439 Nanomedicine & Nanotechnology Research Article Open Access Raman Spectroscopy of Algae: A Review Niranjan D T Parab and Vikas Tomar* School of Aeronautics and Astronautics, Purdue University, West Lafayette, USA Abstract Algae are eukaryotic microorganisms which contain chlorophyll and are capable of photosynthesis. In various studies, Raman spectra have been used to identify a particular genus in a group of different types of algae. Each biomolecule has its own signature Raman spectrum. This characteristic signal can be used to identify and characterize the biomolecules in algae. Raman spectrum can be used to identify the components, determine the molecular structure and various properties of biomolecules in algae. With this view, this work presents a comprehensive review of current practices and advancements in Raman spectroscopy of Algae as well as in Raman spectroscopy of component biomolecules of different genus of Algae. Keywords: Raman spectroscopy; Algae; Biomolecule; Bio-analysis; depending on the changes in environmental conditions [3]. Based on Identification such attributes, algae have led to new development in applications such as sensing elements in biosensors [6-15]. Algae cells have also been Introduction used as an aid in controlling water pollution and heavy metal pollution Raman spectroscopy has proven to be a powerful and versatile [10,12,13,15]. One of the most important and visible uses of algae characterization tool used for determining chemical composition of has been in the domain of biofuel development due to superior lipid content in algae cells compared to other plant cells [16,17].
    [Show full text]