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- BookLinda O. Narhi, editor.Summary: This book can be used to provide insight into this important application of biophysics for those who are planning a career in protein therapeutic development, and for those outside this area who are interested in understanding it better. The initial chapters describe the underlying theory, and strengths and weaknesses of the different techniques commonly used during therapeutic development. The majority of the chapters discuss the applications of these techniques, including case studies, across the product lifecycle from early discovery, where the focus is on identifying targets, and screening for potential drug product candidates, through expression and purification, large scale production, formulation development, lot-to-lot comparability studies, and commercial support including investigations.
Contents:
Introduction / Linda O. Narhi
High-Throughput Biophysical Approaches to Therapeutic Protein Development / Feng He, Vladimir I. Razinkov
Techniques for Higher-Order Structure Determination / James Kranz, Fatma AlAzzam, Atul Saluja
Biophysical Techniques for Protein Size Distribution Analysis / Ziping Wei, Alla Polozova
Qualification of Biophysical Methods for the Analysis of Protein Therapeutics / Yijia Jiang, Cynthia Li, John Gabrielson
Application of Biophysics to the Early Developability Assessment of Therapeutic Candidates and Its Application to Enhance Developability Properties / Hasige Sathish, Nicolas Angell, David Lowe
Application of Biophysics in Formulation, Process, and Product Characterization: Selected Case Studies / Satish K. Singh, Qin Zou, Min Huang
Biophysical Analysis in Support of Development of Protein Pharmaceuticals / Sreedhara Alavattam, Barthelemy Demeule
Case Studies Applying Biophysical Techniques to Better Characterize Protein Aggregates and Particulates of Varying Size / Tingting Wang, Sangeeta B. Joshi
Investigation of Nonconformance During Protein Therapeutic Manufacturing / Zai-Qing Wen, Gianni Torraca, Guiyang Li
Higher-Order Structure and Protein Aggregate Characterization of Protein Therapeutics: Perspectives from Good Manufacturing Practices and Regulatory Guidance / Evi B. Struble, John F. Cipollo.Digital Access Springer 2013 - ArticleObladen M.Eur J Pediatr. 1978 Jul 03;128(3):129-43.In order to evaluate the surfactant maturation of the neonate, tracheal aspirates were analyzed in 84 newborn infants with 12h of birth. Using 2-dimensional thin-layer chromatography, 9 different phospholipids were identified. Dynamic surface tension measurements were performed with a modified Wilhelmy balance. Five different groups of infants with typical phospholipid patterns were characterized: i.e., 1. Normal term newborn. 2. RDS in the preterm infant. 3. Acceleration of lung maturity in preterm infants without RDS. 4. Retardation in term infants with RDS. 5. Therapeutic induction of pulmonary maturity in preterm infants following maternal glucocorticoid administration. Mature lung effluent contains high concentrations of phosphatidylcholine (PC) and phsophatidylglycerol (PG). In infants with RDS, PC is low and PG absent. Accelerated lung maturity was observed after chronic prenatal stress, such as prolonged rupture of the membranes, chronic vaginal bleeding, and maternal hepatitis or drug addiction. Retardation of pulmonary maturity was seen in infants with alpha-1-AT-deficiency, maternal diabetes and maternal hypothyroidism. Administration of methylprednisolone to the mother 24 h to 72h before birth induced both the synthesis of PC and PG in the preterm infants, resulting in an almost full-term phospholipid pattern as early as 31 weeks of gestation. The significance of these factors on the pathogenesis of RDS is discussed.