Literature DB >> 9737396

Quality of biotechnological products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. ICH Harmonised Tripartite Guideline.

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Year:  1998        PMID： 9737396

Source DB:  PubMed          Journal:  Dev Biol Stand        ISSN： 0301-5149


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  10 in total

1.  Application of methods for viral clearance in stem cell production.

Authors:  Fernando Cobo
Journal:  In Vitro Cell Dev Biol Anim       Date:  2007-10-13       Impact factor: 2.416

2.  Flebogamma 5% DIF development: rationale for a new option in intravenous immunoglobulin therapy.

Authors:  J I Jorquera
Journal:  Clin Exp Immunol       Date:  2009-09       Impact factor: 4.330

Review 3.  [Basics of the pharmacology of biopharmaceuticals].

Authors:  Johannes Wohlrab
Journal:  Hautarzt       Date:  2019-12       Impact factor: 0.751

4.  Inactivation of Viruses and Bacteriophages as Models for Swine Hepatitis E Virus in Food Matrices.

Authors:  Eva Emmoth; Jordi Rovira; Andreja Rajkovic; Elena Corcuera; Diego Wilches Pérez; Irene Dergel; Jakob R Ottoson; Frederik Widén
Journal:  Food Environ Virol       Date:  2016-10-25       Impact factor: 2.778

5.  GMP Compliant Production of a Cryopreserved Adipose-Derived Stromal Cell Product for Feasible and Allogeneic Clinical Use.

Authors:  Mandana Haack-Sørensen; Ellen Mønsted Johansen; Lisbeth Drozd Højgaard; Jens Kastrup; Annette Ekblond
Journal:  Stem Cells Int       Date:  2022-06-20       Impact factor: 5.131

6.  A comprehensive microbiological safety approach for agarose encapsulated porcine islets intended for clinical trials.

Authors:  Lawrence S Gazda; James Collins; Archie Lovatt; Robert W Holdcraft; Merribeth J Morin; Daniel Galbraith; Melanie Graham; Melissa A Laramore; Christine Maclean; John Black; Euan W Milne; Douglas G Marthaler; Horatiu V Vinerean; Michelle M Michalak; Deborah Hoffer; Steven Richter; Richard D Hall; Barry H Smith
Journal:  Xenotransplantation       Date:  2016-11-11       Impact factor: 3.907

7.  Chromatographic removal combined with heat, acid and chaotropic inactivation of four model viruses.

Authors:  R Valdés; Neysi Ibarra; I Ruibal; A Beldarraín; E Noa; N Herrera; R Alemán; S Padilla; J Garcia; M Pérez; R Morales; E Chong; B Reyes; Y Quiñones; A Agraz; L Herrera
Journal:  J Biotechnol       Date:  2002-07-03       Impact factor: 3.307

8.  Safety of snake antivenom immunoglobulins: efficacy of viral inactivation in a complete downstream process.

Authors:  C P Caricati; L Oliveira-Nascimento; J T Yoshida; A T P Caricati; I Raw; M A Stephano
Journal:  Biotechnol Prog       Date:  2013-06-27

9.  Immortalized human myoblast cell lines for the delivery of therapeutic proteins using encapsulated cell technology.

Authors:  Aurelien Lathuiliere; Remi Vernet; Emily Charrier; Muriel Urwyler; Olivier Von Rohr; Marie-Claude Belkouch; Valentin Saingier; Thomas Bouvarel; Davy Guillarme; Adrien Engel; Patrick Salmon; Thomas Laumonier; Julien Grogg; Nicolas Mach
Journal:  Mol Ther Methods Clin Dev       Date:  2022-08-01       Impact factor: 5.849

10.  Sensitivity and breadth of detection of high-throughput sequencing for adventitious virus detection.

Authors:  Robert L Charlebois; Sarmitha Sathiamoorthy; Carine Logvinoff; Lucy Gisonni-Lex; Laurent Mallet; Siemon H S Ng
Journal:  NPJ Vaccines       Date:  2020-07-17       Impact factor: 7.344
  10 in total

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