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

Popkin, Matthew E; Goese, Markus; Wilkinson, Diane; Finnie, Stuart; Flanagan, Talia; Campa, Cristiana; Clinch, Alexandra; Teasdale, Andrew; Lennard, Andrew; Cook, Graham; Mohan, Ganapathy; Osborne, Matthew D

Popkin, Matthew E; Goese, Markus; Wilkinson, Diane; Finnie, Stuart; Flanagan, Talia; Campa, Cristiana; Clinch, Alexandra; Teasdale, Andrew; Lennard, Andrew; Cook, Graham; Mohan, Ganapathy; Osborne, Matthew D.

Afiliação

Popkin ME; GSK, David Jack Centre for R&D, Park Road, Ware, SG12 0DP, UK.
Goese M; F. Hoffmann-La Roche Ltd, CH-4070, Basel, Switzerland.
Wilkinson D; AstraZeneca, Derwent Building, Silk Road Business Park, Charter Way, Macclesfield, SK10 2NA, UK.
Finnie S; AstraZeneca, Charter Way, Macclesfield, SK10 2NA, UK.
Flanagan T; UCB Pharma SA, 1420, Braine l'Alleud, Belgium.
Campa C; GSK, Via Fiorentina 1, 53100, Siena, Italy.
Clinch A; UCB Pharma, 208 Bath Road, Slough, SL1 3WE, Berkshire, UK.
Teasdale A; AstraZeneca, Chemical Development, Pharmaceutical Technology and Development, Operations, Charter Way, Macclesfield, Macclesfield, SK10 2NA, UK.
Lennard A; Amgen, 4, Uxbridge Business Park, Sanderson Road, Uxbridge, UB8 1DH, UK.
Cook G; Pfizer Ltd., Walton Oaks, Dorking Road, Tadworth, KT20 7NS, Surrey, UK.
Mohan G; Merck & Co., Inc., 770 Sumneytown Pike, West Point, PA, 19486, USA. ganapathy_mohan@merck.com.
Osborne MD; Eli Lilly Kinsale Ltd, Dunderrow, Kinsale, P17 NY71, Co. Cork, Ireland.

AAPS J ; 24(6): 101, 2022 09 27.

Article em En | MEDLINE | ID: mdl-36168002

Assuntos

COVID-19; Vacinas; COVID-19/epidemiologia; COVID-19/prevenção & controle; Humanos; Pandemias/prevenção & controle; Vacinas/uso terapêutico

Palavras-chave

CMC; COVID-19, coronavirus; GMP; analytical; anti-viral; chemistry; cleaning; commercial; comparability; control; controls; conventional; distribution; formulation; good manufacturing practice; importation; inspection; manufacturing; packaging; parallel development; presentation; process; regulatory; regulatory authority collaboration; reliance/collaborative assessment; shelf-life; stability; strategy; vaccine; validation

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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Vacinas / COVID-19 Idioma: En Ano de publicação: 2022 Tipo de documento: Article

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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Vacinas / COVID-19 Idioma: En Ano de publicação: 2022 Tipo de documento: Article