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Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development.
Hays, Amanda; Wissel, Mark; Colletti, Kelly; Soon, Russell; Azadeh, Mitra; Smith, Justin; Doddareddy, Rajitha; Chalfant, Melanie; Adamowicz, Wendy; Ramaswamy, Swarna Suba; Dholakiya, Sanjay L; Guelman, Sebastian; Gullick, Bryan; Durham, Jennifer; Rennier, Keith; Nagilla, Pruthvi; Muruganandham, Anamica; Diaz, Manisha; Tierney, Cassandra; John, Kaarthik; Valentine, Jenny; Lockman, Timothy; Liu, Hsing-Yin; Moritz, Benjamin; Ouedraogo, Jean Paul; Piche, Marie-Soleil; Smet, Muriel; Murphy, Jacqueline; Koenig, Kaylyn; Zybura, Agnes; Vyhlidal, Carrie; Mercier, Jonathan; Jani, Niketa; Kubista, Mikael; Birch, Donald; Morse, Karlin; Johansson, Oskar.
Affiliation
  • Hays A; BioAgilytix Laboratories, Durham, North Carolina, USA. amanda.hays@bioagilytix.com.
  • Wissel M; Eurofins Viracor BioPharma Services, Inc., Lenexa, Kansas, USA.
  • Colletti K; Beam Therapeutics, Cambridge, Massachusetts, USA.
  • Soon R; BioMarin Pharmaceutical Inc., Novato, California, USA.
  • Azadeh M; Ultragenyx Pharmaceutical Inc., Novato, Calfornia, USA.
  • Smith J; Pfizer Inc, Groton, Connecticut, USA.
  • Doddareddy R; Merck & Co., Inc., Rahway, New Jersey, USA.
  • Chalfant M; GSK, Collegeville, Pennsylvania, USA.
  • Adamowicz W; PPD Clinical Research, Thermo Fisher Scientific, Richmond, Virginia, USA.
  • Ramaswamy SS; Eli Lilly and Company, Indianapolis, Indiana, USA.
  • Dholakiya SL; Bristol Myers Squibb, Princeton, New Jersey, USA.
  • Guelman S; Genentech, Inc., South San Francisco, California, USA.
  • Gullick B; BioAgilytix Laboratories, Durham, North Carolina, USA.
  • Durham J; BioAgilytix Laboratories, Boston, Massachusetts, USA.
  • Rennier K; Labcorp Drug Development, Greenfield, Indiana, USA.
  • Nagilla P; Asher Biotherapeutics, Inc., South San Francisco, California, USA.
  • Muruganandham A; BioAgilytix Laboratories, Durham, North Carolina, USA.
  • Diaz M; Eurofins Viracor BioPharma Services, Inc., Lenexa, Kansas, USA.
  • Tierney C; Pfizer Inc, Groton, Connecticut, USA.
  • John K; REGENXBIO Inc., Rockville, Maryland, USA.
  • Valentine J; Regeneron Pharmaceuticals, Tarrytown, New York, USA.
  • Lockman T; PPD Clinical Research, Thermo Fisher Scientific, Richmond, Virginia, USA.
  • Liu HY; Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.
  • Moritz B; Charles River Labs, Reno, Nevada, USA.
  • Ouedraogo JP; Charles River Labs, Senneville, Québec, Canada.
  • Piche MS; Charles River Labs, Senneville, Québec, Canada.
  • Smet M; Sanofi, Ghent, Belgium.
  • Murphy J; Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.
  • Koenig K; Altasciences Preclinical Seattle LLC, Everett, Washington, USA.
  • Zybura A; Labcorp Drug Development, Greenfield, Indiana, USA.
  • Vyhlidal C; KCAS Bioanalytical and Biomarker Services, Shawnee, Kansas, USA.
  • Mercier J; Flowmetric Life Sciences, Inc., Spring House, Pennsylvania, USA.
  • Jani N; BioAgilytix Laboratories, Boston, Massachusetts, USA.
  • Kubista M; Institute of Biotechnology Czech Academy of Sciences, Prague, Czech Republic.
  • Birch D; Altasciences Preclinical Seattle LLC, Everett, Washington, USA.
  • Morse K; Altasciences Preclinical Seattle LLC, Everett, Washington, USA.
  • Johansson O; TATAA Biocenter, Gothenburg, Sweden.
AAPS J ; 26(1): 24, 2024 02 05.
Article in En | MEDLINE | ID: mdl-38316745
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Genetic Therapy / Drug Development Type of study: Guideline / Prognostic_studies / Qualitative_research Language: En Journal: AAPS J Journal subject: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Year: 2024 Document type: Article Affiliation country: Estados Unidos Country of publication: Estados Unidos
Fulltext
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Genetic Therapy / Drug Development Type of study: Guideline / Prognostic_studies / Qualitative_research Language: En Journal: AAPS J Journal subject: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Year: 2024 Document type: Article Affiliation country: Estados Unidos Country of publication: Estados Unidos