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    2222 results match your criteria Bioanalysis [Journal]

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    Incurred sample reanalysis: adjusted procedure for sample size calculation.
    Bioanalysis 2017 Nov 9;9(21):1719-1726. Epub 2017 Nov 9.
    Pharmacology Department, Pharmaceutical Research Institute, 8 Rydygiera Street, Warsaw 01-793, Poland.
    Aim: The incurred sample reanalysis (ISR) helps to assure bioanalysis reliability. The regulatory guidelines recommend the reanalysis of up to 10% of the study samples for this test, but not all reanalyses are necessary to evaluate the test result.

    Materials & Methods: We have optimized ISR sample size calculation to eliminate negligible reanalyses. Read More

    The 8th Japan Bioanalysis Forum symposium.
    Bioanalysis 2017 Nov 9. Epub 2017 Nov 9.
    Otsuka Pharmaceutical Co., Ltd., 3-2-27 Otedori, Chuo-ku, Osaka 540-0021, Japan.
    The 8th Japan Bioanalysis Forum symposium, the Tower Hall Funabori, Tokyo, Japan, 8-9 February 2017: The 8th Japan Bioanalysis Forum (JBF) symposium was successfully held between 8 and 9 February 2017 at the Tower Hall Funabori, Tokyo, Japan. In total, 24 speakers from Japan, USA and Europe gave presentations regarding the immunogenicity of biopharmaceuticals, ICH S3A Q&A microsampling, ICH M10 bioanalytical method validation, large molecule analysis through LC-MS, auditing activities for bioanalysis and biomarker bioanalysis. Achievements regarding eight diverse themes were also shared by Japan Bioanalysis Forum discussion groups. Read More

    Current practices and future outlook on the integration of biomarkers in the drug development process.
    Bioanalysis 2017 Nov 9. Epub 2017 Nov 9.
    Pfizer, Eastern Point Rd., Groton, CT 06340, USA.
    Over the last decade, there has been broad incorporation of translational biomarkers into the early drug development process to predict safety concerns, measure target engagement and monitor disease progression. One goal of translational biomarkers is to create a cycle whereby preclinical readouts influence candidate selection and subsequent clinical data are fed back into research to facilitate better decision making. Successes have been limited and not as broad in scope as desired. Read More

    Enantioselective supercritical fluid chromatography-tandem mass spectrometry method for simultaneous estimation of risperidone and its 9-hydroxyl metabolites in rat plasma.
    Bioanalysis 2017 Nov 9. Epub 2017 Nov 9.
    Pharmaceutical Candidate Optimization, Biocon Bristol-Myers Squibb R&D Center (BBRC), Syngene International Limited, Biocon Park, Plot 2 & 3, Bommasandra IV Phase, Bangalore - 560099, India.
    Aim: Objective of the current work was to develop a 'green chemistry' compliant selective and sensitive supercritical fluid chromatography-tandem mass spectrometry method for simultaneous estimation of risperidone (RIS) and its chiral metabolites in rat plasma. Methodology & results: Agilent 1260 Infinity analytical supercritical fluid chromatography system resolved RIS and its chiral metabolites within runtime of 6 min using a gradient chromatography method. Using a simple protein precipitation sample preparation followed by mass spectrometric detection achieved a sensitivity of 0. Read More

    Efficient extraction method using magnetic carbon nanotubes to analyze cocaine and benzoylecgonine in breast milk by GC/MS.
    Bioanalysis 2017 Nov 2;9(21):1655-1666. Epub 2017 Nov 2.
    Departamento de Química, Universidade Federal de Minas Gerais, Belo Horizonte; Brasil, MG, 31270-901, Brazil.
    Aim: The increasing use of cocaine (COC) during breastfeeding has led to growing concern about exposure of infants. Therefore, to study this exposure, a new method to analyze COC and benzoylecgonine in breast milk was developed.

    Methodology: A new extraction method was used for the first time to analyze COC and its major metabolite, benzoylecgonine, in breast milk using magnetic carbon nanotubes partially doped with nitrogen. Read More

    Immediate drop on demand technology (I-DOT) coupled with mass spectrometry via an open port sampling interface.
    Bioanalysis 2017 Nov 2;9(21):1667-1679. Epub 2017 Nov 2.
    Dispendix GmbH, Meitnerstr. 9, 70563 Stuttgart, Germany.
    Aim: The aim of this work was to demonstrate and evaluate the analytical performance of coupling the immediate drop on demand technology to a mass spectrometer via the recently introduced open port sampling interface and ESI. Methodology & results: A maximum sample analysis throughput of 5 s per sample was demonstrated. Signal reproducibility was 10% or better as demonstrated by the quantitative analysis of propranolol and its stable isotope-labeled internal standard propranolol-d7. Read More

    Using miniature MS system with automatic blood sampler for preclinical pharmacokinetics study.
    Bioanalysis 2017 Nov 2;9(21):1633-1641. Epub 2017 Nov 2.
    State Key Laboratory of Precision Measurement Technology & Instruments, Department of Precision Instrument, Tsinghua University, Beijing 100084, PR China.
    Aim: Preclinical pharmacokinetic studies are an essential part of modern drug development. In this work, we explored a new solution with onsite analysis using a miniature MS system, which can significantly improve the efficiency of the preclinical study. Materials & methods: A miniature mass spectrometer was used with an automatic blood sampler for onsite quantitation of drug compounds in whole blood samples. Read More

    Immunoaffinity LC-MS/MS for quantitative determination of a free and total protein target as a target engagement biomarker.
    Bioanalysis 2017 Oct 26;9(20):1573-1588. Epub 2017 Oct 26.
    Research & Development, Bristol-Myers Squibb, Princeton, NJ 08543, USA.
    Aim: IP-10 is a protein target for the treatment of Crohn's disease. Inhibition of IP-10 by anti-IP-10 mAbs neutralizes its various biological activities. The measurement of free IP-10 suppression as a target engagement biomarker is required for the assessment of drug effect on the target. Read More

    Generation of assay positive controls for detection of isotype anti-drug antibodies for immunogenicity monitoring.
    Bioanalysis 2017 Oct 26;9(20):1603-1615. Epub 2017 Oct 26.
    Bioanalytical & Biomarker Development, Shire, Lexington, MA 02421, USA.
    Aim: Development of drug-related surrogate positive controls for isotype anti-drug antibodies assay remains challenging. Efforts on antibody engineering or chemical crosslinking have been made. However, multiple epitope recognition, purity and stability are often of concern. Read More

    Immunoprecipitation middle-up LC-MS for in vivo drug-to-antibody ratio determination for antibody-drug conjugates.
    Bioanalysis 2017 Oct 26;9(20):1535-1549. Epub 2017 Oct 26.
    Safety/ADME Bioanalysis, Pre-Clinical Bioanalysis Mass Spectrometry Sciences, PK Sciences, Novartis, One Health Plaza, East Hanover, NJ 07936, USA.
    Aim: Drug-to-antibody ratio (DAR) determination is critical for development of antibody-drug conjugates (ADCs). This work presents a middle-up LC-MS approach for DAR analysis using prelabeled capture beads and in-house fabricated slit-plates. Methodology & Results: Cysteine, engineered cysteine and disulfide-linked ADCs, each with two different linker payloads, were immunocaptured and digested to scFc and F(ab')2 fragments. Read More

    Multiplexing determination of cancer-associated biomarkers by surface-enhanced Raman scattering using ordered gold nanohoneycomb arrays.
    Bioanalysis 2017 Oct 26;9(20):1561-1572. Epub 2017 Oct 26.
    State Key Laboratory of Bioelectronics, School of Biological Science & Medical Engineering, Southeast University, Nanjing 210096, PR China.
    Aim: Here, a multiplex surface-enhanced Raman scattering (SERS) based assay for simultaneous quantitation of carcinoembryonic antigen (CEA) and α-fetoprotein (AFP) was developed.

    Methods: SERS tags of nanostars and SERS substrates of nanobowl arrays were functionalized with labeling and capturing antibodies, respectively. In presence of antigens, SERS tags, antigens and SERS substrates formed sandwich structure. Read More

    Overcoming challenges associated with the bioanalysis of an ester prodrug and its active acid metabolite.
    Bioanalysis 2017 Oct 26;9(20):1589-1601. Epub 2017 Oct 26.
    Bioanalysis, Immunogenicity, & Biomarkers, IVIVT, GlaxoSmithkline (GSK) Pharmaceuticals, 709 Swedeland Road, King of Prussia, PA 19406, USA.
    Aim: Bioanalysis of ester prodrugs represents a great analytical challenge due to poor matrix stability in the presence of esterases. Materials & methods: An approach that includes pH control, temperature and the use of an inhibitor (sodium fluoride, NaF) was employed for complete stabilization of an ester prodrug and its corresponding acid metabolite. Stability information was used to design a methodology with negligible ex vivo hydrolysis of the ester to the corresponding acid analyte during all critical parts of bioanalysis. Read More

    Clinical and pharmaceutical success from discovery to regulatory approval: biomarkers, modeling and analytical technologies.
    Bioanalysis 2017 Oct 21;9(19):1437-1440. Epub 2017 Oct 21.
    Milestone Development Services, 7 Snowdrop Place, Newtown, PA 18940, USA.
    The 8th Annual Shanghai Symposium on Clinical and Pharmaceutical Solutions through Analysis (CPSA): Clinical and Pharmaceutical Success from Discovery to Regulatory Approval: Biomarkers, Modeling and Analytical Technologies (CPSA Shanghai 2017); Renaissance Shanghai Pudong Hotel, Shanghai, China, 12-14 April 2017 was held on 12-14 April 2017 in Shanghai, China. The meeting was featured with highly interactive events including diversified symposia, workshops, roundtable discussions, conference awards and poster sessions. There were over 220 participants with 61 oral presentations and 20 posters presented. Read More

    Spotting of external calibration standards on blank dried blood spots as a resource-sparing protocol.
    Bioanalysis 2017 Oct 21;9(19):1441-1450. Epub 2017 Oct 21.
    Pharmaceutical Candidate Optimization, Biocon Bristol-Myers Squibb R&D Center (BBRC), Syngene International Limited, Biocon Park, Plot 2 & 3, Bommasandra IV Phase, Bangalore - 560 099, India.
    Aim: Dried blood spots (DBS) offer significant ethical and scientific advantages; however preparation of calibration curves often times, off-sets some of these advantages. We have developed a methodology wherein small volumes of external calibration standards can be spiked on to blank DBS cards.

    Results: A total of 2 μl of stock solution spotted on to blank blood spots yielded concentrations that were comparable to those obtained using conventional DBS method. Read More

    2D-LC-MS/MS to measure cleaved high-molecular-weight kininogen in human plasma as a biomarker for C1-INH-HAE.
    Bioanalysis 2017 Oct 21;9(19):1477-1491. Epub 2017 Oct 21.
    Bioanalytical & Biomarker Development, Research & Nonclinical Development, Shire, Lexington, MA 02421, USA.
    Aim: C1-INH-HAE is caused by activation of plasma kallikrein which subsequently cleaves high-molecular-weight kininogen (HMWK) to generate bradykinin and cHMWK.

    Materials & Methods: A novel ion-pair 2D LC-MS/MS assay was developed to measure the 46 kDa cHMWK in plasma as a biomarker for C1-INH-HAE. The sample preparation included sodium dodecyl sulfate denaturation, methanol crash, chymotryptic digestion and peptide enrichment by solid phase extraction. Read More

    Development of sampling method and chromatographic analysis of volatile organic compounds emitted from human skin.
    Bioanalysis 2017 Oct 21;9(19):1465-1475. Epub 2017 Oct 21.
    Institute of Nuclear Physics, Polish Academy of Sciences, PL-31342 Krakow, Poland.
    Aim: The studies on volatile organic compounds emitted from skin are an interest for chemists, biologists and physicians due to their role in development of different scientific areas, including medical diagnostics, forensic medicine and the perfume design. This paper presents a proposal of two sampling methods applied to skin odor collection: the first one uses a bag of cellulose film, the second one, using cellulose sachets filled with active carbon.

    Materials & Methods: Volatile organic compounds were adsorbed on carbon sorbent, removed via thermal desorption and analyzed using gas chromatograph with mass spectrometer. Read More

    Advances in human chorionic gonadotropin detection technologies: a review.
    Bioanalysis 2017 Oct 21;9(19):1509-1529. Epub 2017 Oct 21.
    Jiangsu Key Laboratory of Environmental Engineering & Monitoring, & Testing Center, The College of Chemistry & Chemical Engineering, Yangzhou University, 180 Si-Wang-Ting Road, Yangzhou 225002, PR China.
    Human chorionic gonadotropin (HCG) is a glycoprotein secreted by placental trophoblast cells in pregnancy. HCG is a heterodimer composed of two different α- and β-subunits, with the latter being unique to HCG. As well as being the most important diagnostic markers for pregnancy, HCG is also a tumor marker, therefore, quantitative detection of HCG is of great value. Read More

    Addressing the challenges of biomarker calibration standards in ligand-binding assays: a European Bioanalysis Forum perspective.
    Bioanalysis 2017 Oct 21;9(19):1493-1508. Epub 2017 Oct 21.
    European Bioanalysis Forum, Belgium.
    The analysis of biomarkers by ligand-binding assays offers significant challenges compared with the bioanalysis of small and large molecule drugs. The presence of endogenous analyte is a commonly cited issue. Also the sourcing and application of appropriate calibration or reference standards can present many issues. Read More

    Novel strategy using tryptic peptide immunoaffinity-based LC-MS/MS to quantify denosumab in monkey serum.
    Bioanalysis 2017 Oct 21;9(19):1451-1463. Epub 2017 Oct 21.
    School of Pharmacy, Yantai University, 264005 Yantai, PR China.
    Aim: Denosumab is a recombinant fully human IgG2 that has a high affinity and specificity for human RANKL. Commercially available RANKL labeled with an Fc fragment cannot be used to establish an indirect ELISA. To characterize denosumab pharmacokinetic a robust and accuracy method should be developed urgently. Read More

    Assay signal as an alternative to titer for assessment of magnitude of an antidrug antibody response.
    Bioanalysis 2017 Oct 12. Epub 2017 Oct 12.
    Clinical Immunology, Amgen, Thousand Oaks, CA 91320, USA.
    Background: Titer methods are commonly used to characterize the magnitude of an antidrug antibody response. Assay S/N is an appealing alternative, but the circumstances under which use of signal-to-noise (S/N) is appropriate have not been well defined.

    Results: We validated both titer and S/N-based methods for several therapeutics. Read More

    A highly selective and sensitive LC-MS/HRMS assay for quantifying coproporphyrins as organic anion-transporting peptide biomarkers.
    Bioanalysis 2017 Oct 5. Epub 2017 Oct 5.
    Research & Development, Pharmacokinetics, Dynamics & Metabolism, Pfizer Inc., 445 Eastern Point Road, Groton, CT 06340, USA.
    Aim: Coproporphyrin-I (CP-I) and coproporphyrin-III (CP-III) in plasma and urine have been proposed as biomarkers for assessing drug-drug interactions involving hepatic drug transporters such as organic anion-transporting peptides (OATP), 1B1 and 1B3. Materials & methods: Plasma and urine extracts were analyzed for CP-I/CP-III using a TripleTOF API6600 HRMS. Results: Previously unreported, CP-I/CP-III doubly charged ions (m/z 328. Read More

    Cross-reactivity of selected benzofurans with commercial amphetamine and ecstasy immunoassays in urine.
    Bioanalysis 2017 Oct 4. Epub 2017 Oct 4.
    Balearic Islands Health Research Institute (IdISBa), 07120 Palma de Mallorca, Spain.
    Aim: The aim of this study was to perform a cross-reactivity investigation of six benzofurans with immunoassays (IAs) screening tests for amphetamines and ecstasy in urine samples.

    Methods: The following benzofuranes were investigated: 5-(2-Methylaminopropyl)Benzofuran (5-MAPB), 5-(2-methylaminopropyl)-2,3-dihydrobenzofuran (5-MAPDB), 5-(2-Aminopropyl)-Benzofuran (5-APB), 5-(2-Aminopropyl)-2,3-dihydrobenzofuran (5-APDB), 5-(2-Ethylaminopropyl)Benzofuran (5-EAPB) and 5-(2-Aminoethyl)-2,3-dihydrobenzofuran (5-AEDB). The study was performed with urine-free spiked samples and authentic urine samples using eight different IAs for amphetamines and ecstasy. Read More

    A sensitive and accurate method to simultaneously measure uric acid and creatinine in human saliva by using LC-MS/MS.
    Bioanalysis 2017 Oct 2. Epub 2017 Oct 2.
    Center for Nephrology & Metabolomics & Division of Nephrology & Rheumatology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.
    Aim: To establish a method to simultaneously measure uric acid (UA) and creatinine (Cr) in human saliva.

    Materials & Methods: By using HPLC-MS/MS, we developed and validated a fast, sensitive and accurate method to simultaneously determine UA and Cr in human saliva. The determination range for Cr and UA is of 10-5000 ng/ml with the R(2) for both calibration curves over 0. Read More

    Method establishment for discerned immunogenicity assessment of a recombinant glycoprotein containing nonhuman sialic acid Neu5Gc residues.
    Bioanalysis 2017 Sep;9(18):1385-1393
    Celerion Switzerland AG, 8320 Fehraltorf, Switzerland.
    Aim: Recombinant glycoprotein produced in nonhuman mammalian cell lines can be modified with the immunogenic nonhuman sialic N-glycolylneuraminic acid (Neu5Gc). We describe here a validated method for detection of antidrug antibodies against both protein and Neu5Gc-containing glycan epitopes.

    Results: An electrochemiluminescent method was established with drug conjugates as capture and detection reagents. Read More

    Evaluation of the potential use of hybrid LC-MS/MS for active drug quantification applying the 'free analyte QC concept'.
    Bioanalysis 2017 Nov 27;9(21):1705-1717. Epub 2017 Sep 27.
    Roche Pharma Research & Early Development (pRED), Pharmaceutical Sciences, Global DMPK & Bioanalytical R&D, Roche Innovation Center Munich, Nonnenwald 2, 82377 Penzberg, Germany.
    Aim: Assessment of active drug exposure of biologics may be crucial for drug development. Typically, ligand-binding assay methods are used to provide free/active drug concentrations. To what extent hybrid LC-MS/MS procedures enable correct 'active' drug quantification is currently under consideration. Read More

    Implementing a tiered approach to bioanalytical method validation for large-molecule ligand-binding assay methods in pharmacokinetic assessments.
    Bioanalysis 2017 Sep 18;9(18):1407-1422. Epub 2017 Sep 18.
    Biologics Development Sciences, Janssen BioTherapeutics, Janssen R&D, LLC, 1400 McKean Road, PO Box 776, Spring House, PA 19477, USA.
    Bioanalytical methods must enable the delivery of data that meet sound, scientifically justified, fit-for-purpose criteria. At early phases of biotherapeutic drug development, suitable criteria of a ligand-binding assay could be met for pharmacokinetic (PK) in-study sample testing without a full validation defined by regulatory guidelines. To ensure fit-for-purpose methods support PK testing through all phases of biotherapeutic development, three tiers of method validation - regulatory, scientific and research validations - are proposed. Read More

    Investigation of O-glycosylation heterogeneity of recombinant coagulation factor IX using LC-MS/MS.
    Bioanalysis 2017 Sep 18;9(18):1361-1372. Epub 2017 Sep 18.
    Asia Glycomics Reference Site, Daejeon, Korea.
    Aim: Recombinant coagulation factor IX (rFIX) has extraordinarily multiple post-translational modifications including N-glycosylation and O-glycosylation which have a drastic effect on biological functions and in vivo recovery. Unlike N-glycosylation extensively characterized, there are a few studies on O-glycosylation due to its intrinsic complexity. In-depth O-glycosylation analysis is necessary to better understand and assess pharmacological activity of rFIX. Read More

    Sensitive and comprehensive analysis of O-glycosylation in biotherapeutics: a case study of novel erythropoiesis stimulating protein.
    Bioanalysis 2017 Sep 18;9(18):1373-1383. Epub 2017 Sep 18.
    Asia Glycomics Reference Site, Chungnam National University, Daejeon, Korea.
    Aim: Glycosylation of recombinant human erythropoietins (rhEPOs) is significantly associated with drug's quality and potency. Thus, comprehensive characterization of glycosylation is vital to assess the biotherapeutic quality and establish the equivalency of biosimilar rhEPOs. However, current glycan analysis mainly focuses on the N-glycans due to the absence of analytical tools to liberate O-glycans with high sensitivity. Read More

    Challenges and opportunities in bioanalytical support for gene therapy medicinal product development.
    Bioanalysis 2017 Sep 18;9(18):1423-1430. Epub 2017 Sep 18.
    Bioanalytical Sciences, Bristol-Myers Squibb, Lawrenceville, NJ 08543, USA.
    Gene and nucleic acid therapies have demonstrated patient benefits to address unmet medical needs. Beside considerations regarding the biological nature of the gene therapy, the quality of bioanalytical methods plays an important role in ensuring the success of these novel therapies. Inconsistent approaches among bioanalytical labs during preclinical and clinical phases have been observed. Read More

    Demonstrating biosimilar and originator antidrug antibody binding comparability in antidrug antibody assays: a practical approach.
    Bioanalysis 2017 Sep 18;9(18):1395-1406. Epub 2017 Sep 18.
    Fresenius-Kabi (SwissBiosim), Z.I. de l'Ouriettaz, 1170 Aubonne, Switzerland.
    Biosimilar drug development has brought new challenges to bioanalytical ligand-binding assays used to determine drug concentration, antidrug antibodies and neutralizing antibodies. One particular challenge is how to demonstrate that the antidrug antibody assay can adequately detect antibodies against both biosimilar and originator. In this paper, we review the current guidelines and literature for practical recommendations and present a gap analysis. Read More

    LC-MS determination of fentanyl in human serum and application to a fentanyl transdermal delivery pharmacokinetic study.
    Bioanalysis 2017 Oct 15;9(20):1551-1560. Epub 2017 Sep 15.
    Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, MD, USA.
    Aim: Fentanyl is an opioid agonist used for acute and chronic pain management. In this report, a highly sensitive and simple LC-MS/MS method using Hydrophilic Interaction Chromatography (HILIC) column was validated and used for fentanyl quantification in human serum.

    Results: The isocratic mobile phase was composed of acetonitrile: 10 mM ammonium formate buffer (pH = 3. Read More

    Evaluation of an FcRn affinity chromatographic method for IgG1-type antibodies and evaluation of IgG variants.
    Bioanalysis 2017 Sep 13;9(17):1305-1317. Epub 2017 Sep 13.
    Pharma Technical Development Analytics Biologics, F. Hoffmann-La Roche Ltd, 4070 Basel, Switzerland.
    Aim: The neonatal Fc-receptor (FcRn) mediates long serum half-life of therapeutic IgG-type antibodies. This interaction represents a critical quality attribute in terms of pharmacokinetics and should be covered by respective quality control strategies. Antibodies are taken up by cells unspecifically and can bind to FcRn in early endosomes preventing lysosomal degradation and allowing release back into circulation. Read More

    Comparative study on microsampling techniques in metabolic fingerprinting studies applying gas chromatography-MS analysis.
    Bioanalysis 2017 Sep 13;9(17):1329-1340. Epub 2017 Sep 13.
    Department of Chemistry, Grupo de Investigación en Química Analítica y Bioanalítica (GABIO), Universidad de los Andes, Cra. 1 No. 18ª-10, Bogotá D.C., Colombia.
    Aim: Sample collection and preparation are important steps in the metabolomics workflow. Any improvement should be aimed toward making them simpler, faster and more reproducible. This paper describes the evaluation of different types of whole blood microsampling techniques applied in a metabolic fingerprinting study of breast cancer patients. Read More

    LC-MS/MS analysis of lipidized analogs of prolactin-releasing peptide utilizing a monolithic column and simple sample preparation.
    Bioanalysis 2017 Sep 13;9(17):1319-1328. Epub 2017 Sep 13.
    Department of Biochemistry and Molecular Biology, Institute of Organic Chemistry & Biochemistry AS CR, Flemingovo náměstí 2, 16610 Prague, Czech Republic.
    Aim: Novel compounds for obesity treatment are currently being studied employing lipidized analogs of anorexigenic neuropeptides. Various analogs of prolactin-releasing peptide have demonstrated their ability to decrease food intake. Adequate analytical tools are required to support corresponding research. Read More

    Development of a plug and play ImmunoPCR technique for the analysis of biomolecules.
    Bioanalysis 2017 Sep 13;9(17):1293-1303. Epub 2017 Sep 13.
    Global Biomarker Discovery & Development, Biogen Inc, Cambridge, MA 02142, USA.
    Aim: ImmunoPCR technology combines the advantages of specificity and robustness of a ligand binding assay with the amplification potential of PCR. We describe through three case studies a plug-and-play immuno polymerase chain reaction (iPCR) technique to measure biomolecules.

    Results: Case Study 1 demonstrated feasibility of measurement of IgG1 in cerebrospinal fluid at the desired level of sensitivity with minimal cost and timelines of clinical assay implementation. Read More

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