12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity.
CRO
GCC
HRMS
certificate of analysis
critical reagents
flow cytometry
method transfer
oligonucleotides
regulatory findings
stability and immunogenicity
Journal
Bioanalysis
ISSN: 1757-6199
Titre abrégé: Bioanalysis
Pays: England
ID NLM: 101512484
Informations de publication
Date de publication:
Jun 2019
Jun 2019
Historique:
pubmed:
20
7
2019
medline:
18
12
2019
entrez:
20
7
2019
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 31319683
doi: 10.4155/bio-2019-0131
doi:
Substances chimiques
Indicators and Reagents
0
Oligonucleotides
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM