Recommendations on qPCR/ddPCR assay validation by GCC.

Autor: Wissel M; Eurofins Viracor BioPharma, Lenexa,Kansas, USA., Poirier M; Altasciences, Everett, Washington, USA., Satterwhite C; Charles River Laboratories, Reno, Nevada, USA., Lin J; Frontage Laboratories, Exton, Pennsylvania, USA., Islam R; Smithers, Gaithersburg, Maryland, USA., Zimmer J; Alturas Analytics, Moscow, Idaho, USA., Khadang A; Axis Clinical, Dilworth, Minnesota, USA., Zemo J; BioAgilytix, Durham, North Carolina, USA., Lester T; BioAgilytix, Durham, North Carolina, USA., Fjording M; BioAgilytix, Durham, North Carolina, USA., Hays A; BioAgilytix, Durham, North Carolina, USA., Hughes N; Biopharmaservices, Toronto, Ontario, Canada., Garofolo F; BRI - a Frontage Company, Vancouver, British Columbia, Canada., Guilbaud R; CellCarta, Montreal, Quebec, Canada., Groeber E; Charles River Laboratories, Ashland, Ohio, USA., Renfrew H; Charles River Laboratories, Shrewsbury, Massachusetts, USA., Colletti K; Charles River Laboratories, Reno, Nevada, USA., Yu M; CIRION, Montreal, Quebec, Canada., Lin J; CMIC, Hoffman Estates, Illinois, USA., Fang X; CR Medicon, Piscataway, New Jersey, USA., Shah S; Frontage Laboratories, Exton, Pennsylvania, USA., Garofolo W; GCC, Toronto, Ontario, Canada., Kar S; GCC, Toronto, Ontario, Canada., Hayes R; ICON Laboratory Services, Whitesboro, New York, USA., Pirro J; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, Kansas, USA., Kane C; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, Kansas, USA., Luna M; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, Kansas, USA., Xu A; Keystone Bioanalytical, Lansdale, Pennsylvania, USA., Cape S; Labcorp, Madison, Wisconsin, USA., O'Dell M; Labcorp, Indianapolis, Indiana, USA., Wheller R; LGC, Ely, UK., Ritzen H; Mercodia, Uppsala, Sweden., Vance J; Nexelis - a Q2 Solutions Company, Seattle, Washington, USA., Farley E; Pharmaron, Germantown, Maryland, USA., Matys K; PPD Laboratories, Richmond, Virginia, USA., Tabler E; PPD Laboratories, Richmond, Virginia, USA., Mylott W; PPD Laboratories, Richmond, Virginia, USA., Yuan M; PPD Laboratories, Richmond, Virginia, USA., Karnik S; Pyxant Labs, Colorado Springs, Colorado, USA., Voelker T; Pyxant Labs, Salt Lake City, Utah, USA., DuBey I; Smithers, Gaithersburg, Maryland, USA., Williard C; Syneos Health, Princeton, New Jersey, USA., Shi J; WuXi AppTec, Plainsboro, New Jersey, USA., Yamashita J; WuXi AppTec, Plainsboro, New Jersey, USA.

Publikováno v: Bioanalysis [Bioanalysis] 2022 Jun; Vol. 14 (12), pp. 853-863. Date of Electronic Publication: 2022 Jun 15.

Recommendations on ELISpot assay validation by the GCC.

Autor: Islam R; Smithers, Gaithersburg, MD, USA., Vance J; AIT Bioscience - a Nexelis Company, Seattle, WA, USA., Poirier M; Altasciences, Everett, WA, USA., Zimmer J; Alturas Analytics, Moscow, ID, USA., Khadang A; Axis Clinical, Dilworth, MN, USA., Williams D; BioAgilytix, Durham, NC, USA., Zemo J; BioAgilytix, Durham, NC, USA., Lester T; BioAgilytix, Durham, NC, USA., Fjording M; BioAgilytix, Durham, NC, USA., Hays A; BioAgilytix, Durham, NC, USA., Hughes N; Biopharmaservices, Toronto, ON, Canada., Garofolo F; BRI - a Frontage Company, Vancouver, BC, Canada., Sheldon C; Celerion, Lincoln, NE, USA., Guilbaud R; CellCarta, Montreal, Quebec, Canada., Satterwhite C; Charles River Laboratories, Reno, NV, USA., Colletti K; Charles River Laboratories, Reno, NV, USA., Groeber E; Charles River Laboratories, Ashland, OH, USA., Renfrew H; Charles River Laboratories, Shrewsbury, MA, USA., Yu M; CIRION, Montreal, Quebec, Canada., Lin J; CMIC, Hoffman Estates, IL, USA., Fang X; CR Medicon, Piscataway, NJ, USA., Wissel M; Eurofins Virocor, Lee's Summit, MO, USA., Beadnell T; Eurofins Virocor, Lee's Summit, MO, USA., Lin J; Frontage Laboratories, Exton, PA, USA., Shah S; Frontage Laboratories, Exton, PA, USA., Garofolo W; GCC, Toronto, ON, Canada., Savoie N; GCC, Toronto, ON, Canada., Hayes R; ICON Laboratory Services, Whitesboro, NY, USA., Pirro J; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, KS, USA., Kane C; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, KS, USA., Luna M; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, KS, USA., Xu A; Keystone Bioanalytical, Lansdale, PA, USA., Cape S; Labcorp, Madison, WI, USA., O'Dell M; Labcorp, Indianapolis, IN, USA., Wheller R; LGC, Ely, UK., Ritzen H; Mercodia, Uppsala, Sweden., Farley E; Pharmaron, Germantown, MD, USA., Kierstead L; PPD Laboratories, Wayne, PA, USA., Mylott W; PPD Laboratories, Richmond, VA, USA., Tabler E; PPD Laboratories, Richmond, VA, USA., Yuan M; PPD Laboratories, Richmond, VA, USA., Karnik S; Pyxant Labs, Colorado Springs, CO, USA., Voelker T; Pyxant Labs, Salt Lake City, UT, USA., DuBey I; Smithers, Gaithersburg, MD, USA., Williard C; Syneos Health, Princeton, NJ, USA., Dong K; United-Power Pharma, Beijing, China., Shi J; WuXi AppTec, Plainsboro, NJ, USA., Yamashita J; WuXi AppTec, Plainsboro, NJ, USA.

Publikováno v: Bioanalysis [Bioanalysis] 2022 Feb; Vol. 14 (4), pp. 187-193.

12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity.

Autor: 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., Karnik S; Pyxant Labs, Colorado Springs, CO 80907, USA., Brown M; Q2 Solutions, Marietta, GA 30067, USA., Lowes S; Q2 Solutions, Ithaca, NY 14850, USA., DuBey I; Smithers Avanza, Gaithersburg, MD 20878, USA., Kulagina N; Smithers Avanza, Gaithersburg, MD 20878, USA., Lindsay J; SNBL USA, Everett, WA 98203, USA; currently part of Altasciences., Williard C; Syneos Health, Princeton, NJ 08540, USA., Wang H; TETRAQ, Herston, QLD 4029, Australia., Malone M; Worldwide Clinical Trials, Austin, TX 78754, USA., Wells E; Worldwide Clinical Trials, Austin, TX 78754, USA., Fang X; WuXi Apptec, Plainsboro, NJ 08536, USA., Moussallie M; WuXi Apptec, Plainsboro, NJ 08536, USA.

Publikováno v: Bioanalysis [Bioanalysis] 2019 Jun; Vol. 11 (12), pp. 1129-1138. Date of Electronic Publication: 2019 Jul 19.

Applying simulation in a consulting environment—tips from airport planners.

Autor: Hewitt, Williard C., Miller, Eric E.

Publikováno v: Proceedings of the 31st Conference Winter Simulation; 12/1/1999, Vol. 1, p67-71, 5p

11th GCC Closed Forum: cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose validation; China Food and Drug Administration bioanalytical method validation.

Autor: Islam R; Celerion, Lincoln, NE, USA., Briscoe C; PRA Health Sciences, Lenexa, KS, USA., Bower J; Covance, Chantilly, VA, USA., Cape S; Covance, Madison, WI, USA., Arnold M; Covance, West Trenton, NJ, USA., Hayes R; MPI Research, Mattawan, MI, USA., Warren M; Atlanbio, Saint-Nazaire, France., Karnik S; Pyxant Labs, Colorado Springs, CO, USA., Stouffer B; PPD Laboratories, Richmond, VA, USA., Xiao YQ; Envigo, Somerset, NJ, USA., van der Strate B; PRA Health Sciences, Assen, The Netherlands., Sikkema D; Frontage Lab, Exton, PA, USA., Fang X; WuXi Apptec, Plainsboro, NJ, USA., Tudoroniu A; 3S - Pharmacological Consultation, Bucharest, Romania., Tayyem R; ACDIMA Center for Bioequivalence & Pharmaceutical Studies, Amman, Jordan., Brant A; AIT Bioscience, Indianapolis, IN, USA., Spriggs F; AIT Bioscience, Indianapolis, IN, USA., Barry C; Alliance Pharma, Malvern, PA, USA., Khan M; Alliance Pharma, Malvern, PA, USA., Keyhani A; Algorithme Pharma, Laval, Quebec, Canada., Zimmer J; Alturas Analytics, Moscow, ID, USA., Caturla MC; Anapharm Europe, Barcelona, Spain., Couerbe P; Atlanbio, Saint-Nazaire, France., Khadang A; Axis Clinicals, Dilworth, MN, USA., Bourdage J; BASi, West Lafayette, IN, USA., Datin J; BioAgilytix, Durham, NC, USA., Zemo J; BioAgilytix, Durham, NC, USA., Hughes N; BioPharma Services, Toronto, Ontario, Canada., Fatmi S; Biotrial Bioanalytical Services Inc., Laval, Quebec, Canada., Sheldon C; Celerion, Lincoln, NE, USA., Fountain S; Charles River Laboratories, Reno, NV, USA., Satterwhite C; Charles River Laboratories, Reno, NV, USA., Colletti K; Charles River Laboratories, Reno, NV, USA., Vija J; Charles River Laboratories, Skokie, IL, USA., Yu M; CIRION Biopharma Research, Laval, Quebec, Canada., Stamatopoulos J; CiToxLAB North America, Laval, Quebec, Canada., Lin J; CMIC, Hoffman Estates, IL, USA., Wilfahrt J; Covance, Salt Lake City, UT, USA., Dinan A; CPR Pharma Services, Adelaide, Australia., Ohorodnik S; Envigo, Somerset, NJ, USA., Hulse J; Eurofins Pharma Bioanalytics Services, Saint Charles, MO, USA., Patel V; Eurofins Pharma Bioanalytics Services, Moorpark, CA, USA., Garofolo W; GCC, Toronto, Ontario, Canada., Savoie N; GCC, Toronto, Ontario, Canada., Brown M; ICON Clinical, Whitesboro, NY, USA., Papac D; ICON Laboratory Services, Whitesboro, NY, USA., Buonarati M; Intertek, San Diego, CA, USA., Hristopoulos G; Intertek, San Diego, CA, USA., Beaver C; inVentiv Health, Quebec City, Quebec, Canada., Boudreau N; inVentiv Health, Quebec City, Quebec, Canada., Williard C; inVentiv Health, Princeton, NJ, USA., Liu Y; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, KS, USA., Ray G; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, KS, USA., Warrino D; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, KS, USA., Xu A; Keystone Bioanalytical, North Wales, PA, USA., Green R; LGC, Fordham, UK., Hayward-Sewell J; LGC, Fordham, UK., Marcelletti J; MicroConstants, San Diego, CA, USA., Sanchez C; MicroConstants, San Diego, CA, USA., Kennedy M; MicroConstants, San Diego, CA, USA., Charles JS; MPI Research, Mattawan, MI, USA., Bouhajib M; Pharma Medica Research Inc., Mississauga, Ontario, Canada., Nehls C; PPD Laboratories, Middleton, WI, USA., Tabler E; PPD Laboratories, Richmond, VA, USA., Tu J; PPD Laboratories, Richmond, VA, USA., Joyce P; Q2 Solutions, Ithaca, NY, USA., Iordachescu A; Pharma Serv International, Bucharest, Romania., DuBey I; Smithers Avanza, Gaithersburg, MA, USA., Lindsay J; SNBL USA, Everett, WA, USA., Yamashita J; SNBL USA, Everett, WA, USA., Wells E; Worldwide Clinical Trials, Austin, TX, USA.

Publikováno v: Bioanalysis [Bioanalysis] 2018 Apr 01; Vol. 10 (7), pp. 433-444. Date of Electronic Publication: 2018 Apr 27.