title: The 10th Annual Bioassays and Bioanalytical Method Development Conference.
abstract: The 10th Annual Bioassays and Bioanalytical Method Development Conference was hosted in Boston, MA, USA on 20-22 October 2014. This meeting brought together scientists from the biopharmaceutical and life sciences industries, the regulatory agency and academia to share and discuss current trends in cell-based assays and bioanalysis, challenges and ideas for the future of the bioassays and bioanalytical method development. The experiences associated with new and innovative technologies were evaluated as well as their impact on the current bioassays methodologies and bioanalysis workflow, including quality, feasibility, outsourcing strategies and challenges, productivity and compliance. Several presentations were also provided by members of the US FDA, sharing both scientific and regulatory paradigms including a most recent update on the position of the FDA with specific aspects of the draft Bioanalytical Method Validation guidance following its review of the industry's responses. The meeting was jointly coincided with the 15th Annual Immunogenicity for Biotherapeutics meeting, allowing for attendees to also familiarize themselves with new and emerging approaches to overcome the effect of immunogenicity, in addition to investigative strategies.
authors.affiliation: 1 Amgen Center Dr., Thousand Oaks, CA 91320, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Ma
authors.forename: Christopher
authors.initials: C
authors.lastname: Tudan
authors.forename: Dolly
authors.initials: D
authors.lastname: Koltchev
mesh_terms: D001681:Biological Assay; D002623:Chemistry Techniques, Analytical / Q000379:methods*; D003226:Congresses as Topic; D006801:Humans
keywords: analytical platforms; bioanalytical method development; bioassays; bioterapeutics; method development strategies; method validation; regulatory perspectives