Literature DB >> 26608693

Examining Manufacturing Readiness for Breakthrough Drug Development.

Earl Dye1, Annie Sturgess2, Gargi Maheshwari3, Kimberly May4, Colleen Ruegger5, Usha Ramesh6, Heow Tan7, Keith Cockerill8, John Groskoph9, Emanuela Lacana10, Sau Lee11, Sarah Pope Miksinski12.   

Abstract

Keywords:  CMC; FDA; breakthrough therapy

Mesh：

Year:  2015        PMID： 26608693     DOI： 10.1208/s12249-015-0455-1

Source DB:  PubMed          Journal:  AAPS PharmSciTech        ISSN： 1530-9932            Impact factor:   3.246


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  3 in total

Review 1.  How to accelerate the supply of vaccines to all populations worldwide? Part I: Initial industry lessons learned and practical overarching proposals leveraging the COVID-19 situation.

Authors:  Mic McGoldrick; Thierry Gastineau; Diane Wilkinson; Cristiana Campa; Norbert De Clercq; Andrea Mallia-Milanes; Olivier Germay; Jyothsna Krishnan; M Van Ooij; Michael P Thien; Peter J Mlynarczyk; Edward Saltus; Philippe Juvin; Didier Clenet; Ana Basso; Nora Dellepiane; Sonia Pagliusi; Monique Collaço de Moraes Stávale; Venkatraman H Sivaramakrishnan; Samir Desai
Journal:  Vaccine       Date:  2022-02-23       Impact factor: 3.641

Review 2.  Chemistry Manufacturing and Controls Development, Industry Reflections on Manufacture, and Supply of Pandemic Therapies and Vaccines.

Authors:  Matthew E Popkin; Markus Goese; Diane Wilkinson; Stuart Finnie; Talia Flanagan; Cristiana Campa; Alexandra Clinch; Andrew Teasdale; Andrew Lennard; Graham Cook; Ganapathy Mohan; Matthew D Osborne
Journal:  AAPS J       Date:  2022-09-27       Impact factor: 3.603

3.  Rapid optimization of processes for the integrated purification of biopharmaceuticals.

Authors:  Laura E Crowell; Sergio A Rodriguez; Kerry R Love; Steven M Cramer; J Christopher Love
Journal:  Biotechnol Bioeng       Date:  2021-05-04       Impact factor: 4.530
  3 in total

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