Recommendations on qPCR/ddPCR assay validation by GCC

Autor: Mark Wissel, Martin Poirier, Christina Satterwhite, John Lin, Rafiq Islam, Jennifer Zimmer, Ardeshir Khadang, Jennifer Zemo, Todd Lester, Marianne Fjording, Amanda Hays, Nicola Hughes, Fabio Garofolo, Rudolf Guilbaud, Elizabeth Groeber, Heidi Renfrew, Kelly Colletti, Mathilde Yu, Jenny Lin, Xinping Fang, Santosh Shah, Wei Garofolo, Sumit Kar, Roger Hayes, John Pirro, Cheikh Kane, Marsha Luna, Allan Xu, Stephanie Cape, Mark O'Dell, Robert Wheller, Hanna Ritzen, Jennifer Vance, Esme Farley, Katie Matys, Edward Tabler, William Mylott, Moucun Yuan, Shane Karnik, Troy Voelker, Ira DuBey, Clark Williard, Jing Shi, Jim Yamashita

Publikováno v: Bioanalysis. 14(12)

Gene therapy, cell therapy and vaccine research have led to an increased use of qPCR/ddPCR in bioanalytical laboratories. CROs are progressively undertaking the development and validation of qPCR and ddPCR assays. Currently, however, there is limited

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::01eccf59850771b36ff829a65cebe1d2
https://pubmed.ncbi.nlm.nih.gov/35703321

Recommendations for the content and management of Certificates of Analysis for reference standards from the GCC for bioanalysis

Autor: Stacie McCown, Dave Williams, Esme Farley, Jennifer Zimmer, Mark O'Dell, Roger Hayes, Joseph Bower, Ashley Brant, Colin Barry, Todd Lester, Shane Karnik, Elizabeth Groeber, Wei Garofolo, Jennifer Vance, Edward Tabler, Amanda Hays, Dawn Dufield, Marsha Luna, Mitesh Sanghvi, Kurt J. Sales, Rachel Sun, Kelly Dong, Jenny Lin, Anahita Keyhani, Xinping Fang, Orlando Bravo, Natasha Savoie, Steve Lowes, Daksha Desai-Krieger, Allan Xu, Chris Beaver, Cheikh Kane, Sumit Kar, Heidi Renfrew, Christina Satterwhite, Brian K. Hoffpauir, Fabio Garofolo, Sarah Simchik, Stephanie Cape, Rafiq Islam

Publikováno v: Bioanalysis. 13(8)

The 13th Global CRO Council (GCC) closed forum for bioanalysis was held in New Orleans, LA, USA on 5 April 2019. This GCC meeting was organized to discuss the contents of the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline published in F

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d19d5fd9051d2b19e757ff72eb64a8a6
https://pubmed.ncbi.nlm.nih.gov/33847160

The 10th GCC Closed Forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and counteracting fraud

Autor: Andrea Wakefield, Barry van der Strate, Elizabeth Groeber, Saadya Fatmi, Jing Tu, John Allinson, Yansheng Liu, Hanna Ritzén, John Kamerud, Maria Cruz Caturla, Phyllis Conliffe, Zhongping John Lin, Rafiq Islam, Kayode Awaiye, Chad Briscoe, Jenny Lin, Javier Torres, James Hulse, Jim Yamashita, Shane Karnik, Anahita Keyhani, Simona Rizea Savu, Yinghe Li, Nicola Hughes, Rabab Tayyem, Patrick Bennett, Mike Buonarati, Laura Cojocaru, Wei Garofolo, Steve Lowes, Prashant Kale, Afshin Safavi, Dominic Warrino, Mohammed Bouhajib, Paul Rhyne, Michele Malone, Stephanie Mowery, Bruce Stouffer, Mathilde Yu, Daniel Tang, Masood Khan, Ira DuBey, Neil Adcock, Nadine Boudreau, Radha Shekar, Ardeshir Khadang, Edward O'Connor, Christina Satterwhite, Edward Tabler, Philippe Couerbe, Ron Shoup, Adriana Iordachescu, Jennifer Zimmer, Eric Thomas, Natasha Savoie, Jenifer Vija, Rhonda Johnson, Stephanie Cape, Clark V. Williard, Christina Sanchez, Kai Kurylak, Chris Beaver, Corey Nehls, James Bourdage, Mohamed Osman, Brent Matthews, Roger Hayes, Luigi Silvestro, Michele Fiscella

Publikováno v: Bioanalysis. 9:505-516

The 10th Global CRO Council (GCC) Closed Forum was held in Orlando, FL, USA on 18 April 2016. In attendance were decision makers from international CRO member companies offering bioanalytical services. The objective of this meeting was for GCC member

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1dd221211c9c17d74f26ad79eddd99f3
https://doi.org/10.4155/bio-2017-5000

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

Autor: Ira DuBey, Marc Moussallie, Nadia Kulagina, Dave Williams, Corey Nehls, Rabab Tayyem, Michael E. Brown, Wei Garofolo, Edward Tabler, Philippe Couerbe, Ardeshir Khadang, John Lindsay, Michele Malone, Paul Rhyne, Anahita Keyhani, Mark Warren, Jennifer Zimmer, John Stamatopoulos, Sian Estdale, Clark V. Williard, Bruce Stouffer, Eric Thomas, Mathilde Yu, Rafiq Islam, George Hristopoulos, Simona Rizea Savu, Robert MacNeill, Edward Wells, Jenny Lin, Hanna Ritzén, Iohann Boulay, Natasha Savoie, Kayode Awaiye, Vellalore Kakkanaiah, Shane Karnik, Christina Satterwhite, Curtis Sheldon, Amanda Hays, Chad Briscoe, Kathie Lindley, Colin Barry, Yi Qun Xiao, Andrew Dinan, Allan Xu, Luca Matassa, Arron Xu, Lawrence Goodwin, Steve Lowes, Jessica St Charles, Chantal Di Marco, Mohammed Bouhajib, Maria Cruz Caturla, Nicola Hughes, Patrick Bennett, Jenifer Vija, Stephanie Cape, Roger Hayes, Hao Wang, Xinping Fang, James Bourdage, Franklin Spriggs, Chris Beaver

Publikováno v: Bioanalysis. 11(12)

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 bioanal

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::38c4dbb172c392741c64fb7ad82791fa
https://pubmed.ncbi.nlm.nih.gov/31319683

Looking beyond the WRIB Decennial Index of the White Papers in

Autor: Wei, Garofolo, Natasha, Savoie

Publikováno v: Bioanalysis. 11(7)

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::cfe702d9021437700270951952c32e21
https://pubmed.ncbi.nlm.nih.gov/30945938