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12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity.
Briscoe, Chad; Hughes, Nicola; Hayes, Roger; Islam, Rafiq; Bennett, Patrick; Stouffer, Bruce; Cape, Stephanie; Rhyne, Paul; Beaver, Chris; Charles, Jessica St; Kakkanaiah, Vellalore; Xu, Allan; Caturla, Maria Cruz; Spriggs, Franklin; Tayyem, Rabab; Barry, Colin; Keyhani, Anahita; Zimmer, Jennifer; Couerbe, Philippe; Warren, Mark; Khadang, Ardeshir; Bourdage, James; Lindley, Kathie; Williams, Dave; Sheldon, Curtis; Satterwhite, Christina; Vija, Jenifer; Yu, Mathilde; Boulay, Iohann; Stamatopoulos, John; Lin, Jenny; Estdale, Sian; Thomas, Eric; Dinan, Andrew; MacNeill, Robert; Xiao, Yi Qun; Matassa, Luca; Garofolo, Wei; Savoie, Natasha; Hristopoulos, George; Xu, Arron; Goodwin, Lawrence; Awaiye, Kayode; Ritzén, Hanna; Bouhajib, Mohammed; Marco, Chantal Di; Savu, Simona Rizea; Nehls, Corey; Tabler, Edward; Hays, Amanda.
Affiliation
  • Briscoe C; PRA Health Sciences, Lenexa, KS, USA.
  • Hughes N; BioPharma Services, 4000 Weston Road, North York, Toronto, M9L 3A2 Ontario, Canada.
  • Hayes R; MPI Research, Mattawan, MI 49071, USA.
  • Islam R; Celerion, Lincoln, Nebraska, NE 68502, USA.
  • Bennett P; PPD Laboratories, Richmond, VA 23230, USA.
  • Stouffer B; PPD Laboratories, Richmond, VA 23230, USA.
  • Cape S; Covance, Madison, WI 53704, USA.
  • Rhyne P; Immunologix Laboratories, Tampa, FL 33634, USA.
  • Beaver C; Syneos Health, Princeton, NJ 08540, USA.
  • Charles JS; MPI Research, Mattawan, MI 49071, USA.
  • Kakkanaiah V; PPD Laboratories, Richmond, VA 23230, USA.
  • Xu A; Keystone Bioanalytical, North wales, PA 19454, USA.
  • Caturla MC; Anapharm Bioanalytics, Barcelona 08038, Spain.
  • Spriggs F; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, KS 66216, USA.
  • Tayyem R; ACDIMA Center for Bioequivalence & Pharmaceutical Studies, Amman, Jordan.
  • Barry C; Alliance Pharma, Malvern, PA 19355, USA.
  • Keyhani A; Altasciences, Laval, Quebec H7V 4B3, Canada.
  • Zimmer J; Alturas Analytics, Moscow, ID 83843, USA.
  • Couerbe P; Atlanbio, Route de Saint-André des Eaux, Saint-Nazaire 44600, France.
  • Warren M; Atlanbio, Route de Saint-André des Eaux, Saint-Nazaire 44600, France.
  • Khadang A; Axis Clinicals, Dilworth, MN 56529, USA.
  • Bourdage J; BASi, West Lafayette, IN 47906, USA.
  • Lindley K; BioAgilytix, Durham, NC 27713, USA.
  • Williams D; BioAgilytix, Durham, NC 27713, USA.
  • Sheldon C; Celerion, Lincoln, Nebraska, NE 68502, USA.
  • Satterwhite C; Charles River Laboratories, Reno, NV 89511, USA.
  • Vija J; Charles River Laboratories, Skokie, IL 60077, USA.
  • Yu M; CIRION Biopharma Research, Laval, Quebec H7L 5E1, Canada.
  • Boulay I; CiToxLAB North America, Laval, Quebec H7V 4B3, Canada.
  • Stamatopoulos J; CiToxLAB North America, Laval, Quebec H7V 4B3, Canada.
  • Lin J; CMIC, Hoffman Estates, IL 60192, USA.
  • Estdale S; Covance, Harrogate, HG3 1PY, UK.
  • Thomas E; Covance, Indianapolis, IN 46214, USA.
  • Dinan A; CPR Pharma Services, Adelaide, SA 5031, Australia.
  • MacNeill R; Envigo, Somerset, NJ 08873, USA.
  • Xiao YQ; Envigo, Somerset, NJ 08873, USA.
  • Matassa L; Frontage Lab, Exton, PA 19341, USA.
  • Garofolo W; Grand Challenges Canada, Toronto, Ontario M5G 1M1, Canada.
  • Savoie N; Grand Challenges Canada, Toronto, Ontario M5G 1M1, Canada.
  • Hristopoulos G; Intertek, San Diego, CA 92121, USA.
  • Xu A; Intertek, San Diego, CA 92121, USA.
  • Goodwin L; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, KS 66216, USA.
  • Awaiye K; Lambda Therapeutic Research, Toronto, Ontario M1L 4S4, Canada.
  • Ritzén H; Mercodia AB, Uppsala 754 50, Sweden.
  • Bouhajib M; Pharma Medica Research Inc., Mississauga, Ontario L5R 0B7, Canada.
  • Marco CD; Pharma Medica Research Inc., Mississauga, Ontario L5R 0B7, Canada.
  • Savu SR; Pharma Serv International, Bucharest 050853, Romania.
  • Nehls C; PPD Laboratories, Richmond, VA 23230, USA.
  • Tabler E; PPD Laboratories, Richmond, VA 23230, USA.
  • Hays A; PRA Health Sciences, Lenexa, KS, USA.
Bioanalysis ; 11(12): 1129-1138, 2019 Jun.
Article in En | MEDLINE | ID: mdl-31319683
ABSTRACT
The 12th GCC Closed Forum was held in Philadelphia, PA, USA, on 9 April 2018. Representatives from international bioanalytical Contract Research Organizations were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at the meeting included critical reagents; oligonucleotides; certificates of analysis; method transfer; high resolution mass spectrometry; flow cytometry; recent regulatory findings and case studies involving stability and nonclinical immunogenicity. Conclusions and consensus from discussions of these topics are included in this article.
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Full text: 1 Database: MEDLINE Main subject: Oligonucleotides / Social Control, Formal / Societies, Scientific / Mass Spectrometry / Certification / Chemistry Techniques, Analytical / Flow Cytometry Type of study: Diagnostic_studies Language: En Year: 2019 Type: Article
Fulltext
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PubMed Links
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Full text: 1 Database: MEDLINE Main subject: Oligonucleotides / Social Control, Formal / Societies, Scientific / Mass Spectrometry / Certification / Chemistry Techniques, Analytical / Flow Cytometry Type of study: Diagnostic_studies Language: En Year: 2019 Type: Article