State of the art analytical methods for the characterization of biological products and assessment of comparability
Subtitle: Natcher Building, National Institutes of Health (NIH), Bethesda, MD, USA, June 10-13, 2003 : proceedings of a symposium
By: co-sponsored by the Center for Biologics Evaluation and Research ... [et al.] ; volume editor, Anthony R. Mire-Sluis.
Contributors: Mire-Sluis, Anthony R.; Center for Biologics Evaluation and Research (U.S.)
Series: Developments in biologicals ;; v. 122
Publisher: Karger; S. Karger AG (Switzerland); S. Karger
Published: 2005
Place of publication: Basel; New York
Language: eng
Number of pages: 216
Subjects: Biological products -- Analysis -- Congresses.; Biological products -- Standards -- Congresses.; Biological Products -- analysis -- Congresses.; Biological Products -- immunology -- Congresses.; Quality Control -- Congresses.; Reproducibility of Results -- Congresses.
Genres: Congresses.
Notes: Includes bibliographical references.
Table of contents: title: State of the art analytical comparability: a review / A.J. Chirino, A.R. Mire-Sluis; title: Validation of peptide mapping with electrospray mass spectrometry for recombinant proteins of biopharmaceutical interest and its applications as an identity test and a characterization tool / Z. Wei ... [et al.]; title: Analysis of protein therapeutics by capillary electrophoresis: applications and challenges / S. Ma; title: Mass spectrometry and HPLC for carbohydrate analysis / J. Siemiatkoski, Y. Lyubarskaya; title: Using nuclear magnetic resonance spectroscopy to characterize biologicals / D.I. Freedberg; title: Infrared and raman spectroscopy characterization of biological products / V. Reipa; title: Characterization of an immune response / S.J. Swanson; title: Evaluation of standard and state of the art analytical technology - bioassays / S.R. Indelicato ... [et al.]; title: Heterogeneity of recombinant antibodies: linking structure to function / R.J. Harris; title: Quality control system to support comparability assessment for the renal bio-replacement therapy system / Z. Pitkin; title: Characterization of gene therapy products and the impact of manufacturing changes on product comparability / S.L. Simek; title: Characterization of allergen extracts / J.E. Slater; title: Detection, measurement and characterization of unwanted antibodies induced by therapeutic biologicals / M. Wadhwa ... [et al.]; title: De-immunization of therapeutic proteins by T-cell epitope modification / A.S. de Groot, P.M. Knopf, W. Martin; title: Strategies for the preclinical and clinical characterization of immunogenicity / E. Koren ... [et al.]