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Environmental Health and Biosafety Risk Assessment Guidance for Commercial-Scale Cell and Gene Therapy Manufacturing.
DiGiandomenico, Kimberly; Dunn, Erin; Sadowski, Cari; Godwin, Simon; Keeler, Maureen; Preston, Francine; Niven, Patrick; Ramsey, Phillip; Hay, Helen.
Affiliation
  • DiGiandomenico K; AstraZeneca, Gaithersburg, MD, USA.
  • Dunn E; FUJIFILM Diosynth Biotechnologies, College Station, TX, USA.
  • Sadowski C; FUJIFILM Diosynth Biotechnologies, College Station, TX, USA.
  • Godwin S; Sanofi Genzyme, Framingham, MA, USA.
  • Keeler M; Thermo Fisher Scientific, Cambridge, MA, USA.
  • Preston F; Janssen Pharmaceuticals, Inc., Spring House, PA, USA.
  • Niven P; Janssen Pharmaceuticals, Inc., Spring House, PA, USA.
  • Ramsey P; Sangamo Therapeutics, Inc., Richmond, CA, USA.
  • Hay H; BioPhorum Operations Group Limited, Sheffield, UK.
Appl Biosaf ; 25(4): 201-213, 2020 Dec 01.
Article in En | MEDLINE | ID: mdl-36032393
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Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Etiology_studies / Guideline / Risk_factors_studies Language: En Journal: Appl Biosaf Year: 2020 Document type: Article Affiliation country: United States Country of publication: United States
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Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Etiology_studies / Guideline / Risk_factors_studies Language: En Journal: Appl Biosaf Year: 2020 Document type: Article Affiliation country: United States Country of publication: United States