Today we continue our celebration of Women’s History Month by highlighting another BioAgilytix team member – this time from the technology side of our business. Whitney Gonzales, IT Support Specialist, shares some of her own stories and advice about pursuing a career in STEM.
As part of Women’s History Month we’d like to highlight a few of the many inspiring women on the BioAgilytix team. First we’ve asked Dr. Jennifer Zemo to share some of her stories & advice about pursuing a career in STEM.
It's a common misconception that all aspects of cell & gene therapy research and development are excluded from CLIA oversight. We take a closer look at testing and when CLIA requirements apply.
All CRO laboratories are not created equal. If you are looking for outsourced support for a large molecule program, consider these questions.
BioAgilytix’s Todd Lester answers additional questions submitted by attendees of his recent Bioanalysis Zone webinar on immunogenicity testing for biosimilars.
BioAgilytix’s Todd Lester answers questions submitted by attendees of his recent Bioanalysis Zone webinar on immunogenicity testing for biosimilars.
A new clinical trial by St. Jude Children’s Research Hospital for the treatment of SCID-X1 highlights a major advancement in gene therapy safety over recent years, in this case spurred by scientists who were courageous enough to push forward the development of safer vectors to overcome serious adverse events (SAEs) that were resulting from the previous generation of gene therapies developed for SCID-X1.
We discuss the need to put phase-appropriate methods in place to identify and quantify both process- and host-cell related impurities throughout the drug development process.
On January 23rd I’ll be hosting a webinar with Dr. Dominque Gouty that will summarize key insights from the recently published paper by the American Association of Pharmaceutical Scientists (AAPS) entitled “Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs”. I had the privilege to contribute as an author on this pivotal paper, which lays out a consensus recommendation for use of a one-assay approach to develop and validate ADA assays supporting biosimilar drug development programs. It has taken years of industry discussion and collaboration…
BioAgilytix has been fortunate enough to have several of our team members participate as co-authors on all three AAPS white papers in the series on bioanalytical strategies to support biosimilar programs. Learn more about the papers that collectively represent the culmination of years of discussions across industry and with regulators to create consensus recommendations that will hopefully help shape future regulatory guidelines.
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