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Marta Starcevic Manning, Mark A Kroenke, Stephanie A Lee, Simon E Harrison, Sarah A Hoofring, Daniel T Mytych, Vibha Jawa
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. S/N correlated strongly with titer both in aggregate and when examined on a per subject basis. Analysis of impact of antibody magnitude on pharmacokinetics yielded the same result using either method...
October 12, 2017: Bioanalysis
Ragu Ramanathan, Amanda J King-Ahmad, Christopher L Holliman, A David Rodrigues
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 328.14) were used as precursor ions to improve the assay sensitivity and selectivity over the singly charged precursor ions (m/z 655...
October 5, 2017: Bioanalysis
Isabel Gomila, Concepción Moranta, Loreto Quesada, Yolanda Pastor, Macarena Dastis, Albert Torrents, Miguel Ángel Elorza, Francesco Paolo Busardò, Bernardino Barceló
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)...
October 4, 2017: Bioanalysis
Xin-Ying Liu, Ying Luo, Chun-Yu Zhou, Ai Peng, Jun-Yan Liu
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 0.999. The accuracy, precision and recovery of Cr and UA were all acceptable. By using the established method, the Cr and UA levels in saliva from 28 healthy volunteers were measured as 2...
October 2, 2017: Bioanalysis
Gregor Jordan, Ichio Onami, Julia Heinrich, Roland F Staack
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. Experimental & results: The relevance of appropriate extraction condition was evaluated by a hybrid target capture immuno-affinity LC-MS/MS method using total and free/active quality controls (QCs)...
September 27, 2017: Bioanalysis
Rebecca G Watson, Adrienne Clements-Egan, Allen Schantz, Mark Ware, Bonnie Wu, Tong-Yuan Yang, Gopi Shankar, Joseph C Marini
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...
September 18, 2017: Bioanalysis
Youngsuk Seo, Gyeong Mi Park, Myung Jin Oh, Hyun Joo An
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. RESULTS: We determined unusual O-glycosylations including O-fucosylation and O-glucosylation which were located at Serine 53 and 61, respectively in EGF domain...
September 18, 2017: Bioanalysis
Mark Ma, Nanda Balasubramanian, Robert Dodge, Yan Zhang
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. There are many underlying reasons for this inconsistency. Various platforms and reagents used in quantitative methods, lacking of detailed regulatory guidance on method validation and uncertainty of immunogenicity strategy in supporting gene therapy may all be influential...
September 18, 2017: Bioanalysis
Herbert F Birnboeck, Eginhard Schick, Nicole Justies
No abstract text is available yet for this article.
September 18, 2017: Bioanalysis
Wei Fu, Bo An, Xue Wang, Jun Qu
No abstract text is available yet for this article.
September 18, 2017: Bioanalysis
Mingming Yu, Inas A Abdallah, Soo Hyeon Shin, Dana C Hammell, Audra L Stinchcomb, Hazem E Hassan
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 = 3.2; 90:10, v/v). The assay was linear over a concentration range of 10-10,000 pg/ml. The accuracy of the validation method ranged from 93...
September 15, 2017: Bioanalysis
Florian Cymer, Tilman Schlothauer, Alexander Knaupp, Hermann Beck
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. Reflecting this complex cycle in an in vitro assay strategy represents a challenging task...
September 13, 2017: Bioanalysis
Chaoyan Lou, Yan Zhu
No abstract text is available yet for this article.
September 13, 2017: Bioanalysis
Omnia A Ismaiel, William R Mylott, Rand G Jenkins
No abstract text is available yet for this article.
September 13, 2017: Bioanalysis
Mónica P Cala, Roland Jw Meesters
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. RESULTS: A total of 139, 124 and 128 metabolites were identified in protein precipitation, dried matrix on paper discs and Mitra(®) volumetric absorptive microsampling, respectively in 80% of the sample sets, where the quality control samples had a relative standard deviation of <30%...
September 13, 2017: Bioanalysis
Jana Zemenová, David Sýkora, Anna Freislebenová, Lenka Maletínská
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. Methodology & results: An analytical method was developed that includes simple dilution of plasma samples prior to liquid chromatography-mass spectrometry and employs a monolithic column for the determination of lipidized analogs of prolactin-releasing peptide in complex biological samples...
September 13, 2017: Bioanalysis
Sreeja Gopal, Shobha Purushothama, Alvydas Mikulskis, Lauren Stevenson
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...
September 13, 2017: Bioanalysis
(no author information available yet)
Eric Woolf, Ajai Chaudhary and Sheila Breidinger from Merck, spoke to Sankeetha Nadarajah (Commissioning Editor, Bioanalysis) about outsourcing strategy implementation.
August 10, 2017: Bioanalysis
(no author information available yet)
Christopher Bailey (AstraZeneca) and Lee Goodwin (Covance) speak to Sankeetha Nadarajah (Managing Commissioning Editor, Bioanalysis) about the evolution of the Pharma-CRO working relationship between AstraZeneca and Covance.
August 10, 2017: Bioanalysis
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