13. Biotechnological Products

[1]  R. Nims,et al.  Gamma irradiation of animal sera for inactivation of viruses and mollicutes--a review. , 2011, Biologicals : journal of the International Association of Biological Standardization.

[2]  J. Cizeau,et al.  Development of a GMP Phase III purification process for VB4-845, an immunotoxin expressed in E. coli using high cell density fermentation. , 2011, Protein expression and purification.

[3]  Vinod Kumar,et al.  Modes of Degradation and Impurity Characterization in rhPTH (1–34) during Stability Studies , 2011, PDA Journal of Pharmaceutical Science and Technology.

[4]  H. Aoki,et al.  Methods to select suitable fetal bovine serum for use in quality control assays for the detection of adventitious viruses from biological products. , 2011, Biologicals : journal of the International Association of Biological Standardization.

[5]  H. Cai,et al.  Development of a quantitative PCR assay for residual mouse DNA and comparison of four sample purification methods for DNA isolation. , 2011, Journal of pharmaceutical and biomedical analysis.

[6]  René Gantier,et al.  Designing new monoclonal antibody purification processes using mixed-mode chromatography sorbents. , 2011, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[7]  M. Brgles,et al.  Concentration and purification of rubella virus using monolithic chromatographic support. , 2011, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[8]  K. Yamaguchi,et al.  Applicability of bacterial endotoxins test to various blood products by the use of endotoxin-specific lysates. , 2010, Biologicals : journal of the International Association of Biological Standardization.

[9]  A. Hunter,et al.  Host cell proteins in biologics development: Identification, quantitation and risk assessment , 2009, Biotechnology and bioengineering.

[10]  S. Oscarsson,et al.  A strategic crossflow filtration methodology for the initial purification of promegapoietin from inclusion bodies. , 2009, Journal of biotechnology.

[11]  P. Rakowska,et al.  Physicochemical and biological assays for quality control of biopharmaceuticals: interferon alpha-2 case study. , 2008, Biologicals : journal of the International Association of Biological Standardization.

[12]  B. Parekh,et al.  Root cause investigation of a viral contamination incident occurred during master cell bank (MCB) testing and characterization--a case study. , 2008, Biologicals : journal of the International Association of Biological Standardization.

[13]  Lakshmi Narasu Mangamoori,et al.  Optimization of the downstream process for high recovery of rhG-CSF from inclusion bodies expressed in Escherichia coli , 2008 .

[14]  André Kiesewetter,et al.  Cation exchange chromatography in antibody purification: pH screening for optimised binding and HCP removal. , 2007, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[15]  H. Naderi-manesh,et al.  Improving purification of recombinant human interferon gamma expressed in Escherichia coli; effect of removal of impurity on the process yield. , 2007, Protein expression and purification.

[16]  Peter Reichelt,et al.  Single step protocol to purify recombinant proteins with low endotoxin contents. , 2006, Protein expression and purification.

[17]  K. Champion,et al.  Proteomic studies support the use of multi‐product immunoassays to monitor host cell protein impurities , 2006, Proteomics.

[18]  A. Saul,et al.  A quantitative slot blot assay for host cell protein impurities in recombinant proteins expressed in E. coli. , 2005, Journal of immunological methods.

[19]  U. Reichl,et al.  Downstream processing of MDCK cell-derived equine influenza virus. , 2005, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[20]  Wei Wang,et al.  Protein aggregation and its inhibition in biopharmaceutics. , 2005, International journal of pharmaceutics.

[21]  M. Tsuchiya,et al.  Evaluation of the bacterial endotoxin test for quantification of endotoxin contamination of porcine vaccines. , 2004, Biologicals : journal of the International Association of Biological Standardization.

[22]  A. Rathore,et al.  Analysis for residual host cell proteins and DNA in process streams of a recombinant protein product expressed in Escherichia coli cells. , 2003, Journal of pharmaceutical and biomedical analysis.

[23]  G. Conn,et al.  An enzyme-linked immunosorbent assay for host cell protein contaminants in recombinant PEGylated staphylokinase mutant SY161. , 2002, Journal of pharmaceutical and biomedical analysis.

[24]  T. Nguyen,et al.  Development of a quantitative assay for residual host cell proteins in a recombinant subunit vaccine against human respiratory syncytial virus. , 2001, Journal of immunological methods.

[25]  F B Anspach,et al.  Endotoxin removal from protein solutions. , 2000, Journal of biotechnology.

[26]  DiPaolo,et al.  Monitoring impurities in biopharmaceuticals produced by recombinant technology. , 1999, Pharmaceutical science & technology today.

[27]  R. Lemmens,et al.  Plasmid DNA purification , 1998, Current Opinion in Neurobiology.

[28]  C. Ricordi,et al.  Endotoxin contamination of reagents used during isolation and purification of human pancreatic islets. , 1998, Transplantation proceedings.

[29]  G. Jackowski,et al.  Removal of endotoxin from recombinant protein preparations. , 1997, Clinical biochemistry.