Literature DB >> 18704929

Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality.

John F Carpenter1, Theodore W Randolph, Wim Jiskoot, Daan J A Crommelin, C Russell Middaugh, Gerhard Winter, Ying-Xin Fan, Susan Kirshner, Daniela Verthelyi, Steven Kozlowski, Kathleen A Clouse, Patrick G Swann, Amy Rosenberg, Barry Cherney.   

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Year:  2009        PMID： 18704929      PMCID： PMC3928042          DOI： 10.1002/jps.21530

Source DB:  PubMed          Journal:  J Pharm Sci        ISSN： 0022-3549            Impact factor:   3.534


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  13 in total

Review 1.  Physical stability of proteins in aqueous solution: mechanism and driving forces in nonnative protein aggregation.

Authors:  Eva Y Chi; Sampathkumar Krishnan; Theodore W Randolph; John F Carpenter
Journal:  Pharm Res       Date:  2003-09       Impact factor: 4.200

2.  Heterogeneous nucleation-controlled particulate formation of recombinant human platelet-activating factor acetylhydrolase in pharmaceutical formulation.

Authors:  Eva Y Chi; Joachim Weickmann; John F Carpenter; Mark C Manning; Theodore W Randolph
Journal:  J Pharm Sci       Date:  2005-02       Impact factor: 3.534

Review 3.  Urgent inhibitor issues: targets for expanded research.

Authors:  W K Hoots
Journal:  Haemophilia       Date:  2006-12       Impact factor: 4.287

Review 4.  Immunogenicity of biopharmaceuticals.

Authors:  Michele Kessler; David Goldsmith; Huub Schellekens
Journal:  Nephrol Dial Transplant       Date:  2006-10       Impact factor: 5.992

Review 5.  Protein aggregation and bioprocessing.

Authors:  Mary E M Cromwell; Eric Hilario; Fred Jacobson
Journal:  AAPS J       Date:  2006-09-15       Impact factor: 4.009

Review 6.  Pathogen recognition and development of particulate vaccines: does size matter?

Authors:  Sue D Xiang; Anja Scholzen; Gabriela Minigo; Cassandra David; Vasso Apostolopoulos; Patricia L Mottram; Magdalena Plebanski
Journal:  Methods       Date:  2006-09       Impact factor: 3.608

Review 7.  Mechanisms of action of immune tolerance induction against factor VIII in patients with congenital haemophilia A and factor VIII inhibitors.

Authors:  Birgit M Reipert; Pauline M W van Helden; Pauline M W van den Helden; Hans-Peter Schwarz; Christina Hausl
Journal:  Br J Haematol       Date:  2007-01       Impact factor: 6.998

8.  IgG particle formation during filling pump operation: a case study of heterogeneous nucleation on stainless steel nanoparticles.

Authors:  Anil K Tyagi; Theodore W Randolph; Aichun Dong; Kevin M Maloney; Carl Hitscherich; John F Carpenter
Journal:  J Pharm Sci       Date:  2009-01       Impact factor: 3.534

9.  Acute and long-term stability studies of deoxy hemoglobin and characterization of ascorbate-induced modifications.

Authors:  B A Kerwin; M J Akers; I Apostol; C Moore-Einsel; J E Etter; E Hess; J Lippincott; J Levine; A J Mathews; P Revilla-Sharp; R Schubert; D L Looker
Journal:  J Pharm Sci       Date:  1999-01       Impact factor: 3.534

10.  Structural characterization and immunogenicity in wild-type and immune tolerant mice of degraded recombinant human interferon alpha2b.

Authors:  Suzanne Hermeling; Liliana Aranha; J Mirjam A Damen; Monique Slijper; Huub Schellekens; Daan J A Crommelin; Wim Jiskoot
Journal:  Pharm Res       Date:  2005-10-03       Impact factor: 4.200
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  90 in total

1.  Issues and challenges of subvisible and submicron particulate analysis in protein solutions.

Authors:  Thomas M Scherer; Stephenie Leung; Laura Owyang; Steven J Shire
Journal:  AAPS J       Date:  2012-03-06       Impact factor: 4.009

2.  Discrimination between silicone oil droplets and protein aggregates in biopharmaceuticals: a novel multiparametric image filter for sub-visible particles in microflow imaging analysis.

Authors:  René Strehl; Verena Rombach-Riegraf; Manuel Diez; Kamal Egodage; Markus Bluemel; Margit Jeschke; Atanas V Koulov
Journal:  Pharm Res       Date:  2011-09-27       Impact factor: 4.200

3.  The Coulter principle for analysis of subvisible particles in protein formulations.

Authors:  Matthew N Rhyner
Journal:  AAPS J       Date:  2010-12-14       Impact factor: 4.009

Review 4.  Biosimilarity Versus Manufacturing Change: Two Distinct Concepts.

Authors:  Paul Declerck; Mourad Farouk-Rezk; Pauline M Rudd
Journal:  Pharm Res       Date:  2015-09-17       Impact factor: 4.200

5.  Factors Governing the Precision of Subvisible Particle Measurement Methods - A Case Study with a Low-Concentration Therapeutic Protein Product in a Prefilled Syringe.

Authors:  Anacelia Ríos Quiroz; Jens Lamerz; Thierry Da Cunha; Adeline Boillon; Michael Adler; Christof Finkler; Joerg Huwyler; Roland Schmidt; Hanns-Christian Mahler; Atanas V Koulov
Journal:  Pharm Res       Date:  2015-10-16       Impact factor: 4.200

6.  Holographic Characterization of Protein Aggregates.

Authors:  Chen Wang; Xiao Zhong; David B Ruffner; Alexandra Stutt; Laura A Philips; Michael D Ward; David G Grier
Journal:  J Pharm Sci       Date:  2016-02-02       Impact factor: 3.534

7.  Flow imaging microscopy for protein particle analysis--a comparative evaluation of four different analytical instruments.

Authors:  Sarah Zölls; Daniel Weinbuch; Michael Wiggenhorn; Gerhard Winter; Wolfgang Friess; Wim Jiskoot; Andrea Hawe
Journal:  AAPS J       Date:  2013-08-31       Impact factor: 4.009

8.  DEHP Nanodroplets Leached From Polyvinyl Chloride IV Bags Promote Aggregation of IVIG and Activate Complement in Human Serum.

Authors:  Jared R Snell; Connor R Monticello; Cheng Her; Emma L Ross; Ashley A Frazer-Abel; John F Carpenter; Theodore W Randolph
Journal:  J Pharm Sci       Date:  2019-06-21       Impact factor: 3.534

Review 9.  Watching the gorilla and questioning delivery dogma.

Authors:  Thomas J Anchordoquy; Dmitri Simberg
Journal:  J Control Release       Date:  2017-07-14       Impact factor: 9.776

Review 10.  Protein particulate detection issues in biotherapeutics development--current status.

Authors:  Tapan K Das
Journal:  AAPS PharmSciTech       Date:  2012-05-08       Impact factor: 3.246
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