Questions on Immunogenicity Testing for Biosimilars Answered: Part 1
BioAgilytix’s Todd Lester answers 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.
What makes BioAgilytix an exciting place to work? We talk to Matthew Hoyle, our Associate Director, Global Marketing – whom is a BioAgilytix returning employee after spending 4 years in different business – to find out what drove him back to the company, and what programs he is spearheading now to make the worldwide pharma and biotech industry aware of the premier large molecule expertise available to them through BioAgilytix.
With innovative research driving pharmaceutical and biotech breakthroughs, industry progress is accelerating at a rapid pace. We've compiled some recent industry articles on the latest topics to share with you.
Cell-based bioassays are expected by health agencies as one of the release specification methods for potency assessments in the drug development process. We take a closer look at the inherent complexities that come with developing these assays under GMP, and ways they can be overcome.
Most bioanalytical methods for canonical small or large molecule drugs utilize ligand binding or LC–MS technology for pharmacokinetic (PK) assessments. CAR-T cell therapies involve administration of ‘living drugs’ capable of proliferation after infusion. This behavior is very different from conventional drug compounds, and the term ‘cellular kinetics’ was coined for in vivo ‘PK monitoring’ of both the expansion and persistence of the genetically engineered CAR-T cells.
We strive to foster an environment where our team members can continually grow within their role and within the company – not only upwards, but also into positions they come to find most suited to their unique skills and interests. In this Team Q&A session, we talk to Tatjana Ackermann, Quality Assurance Auditor, about her career path at BioAgilytix since starting in our European lab five years ago.
Services
Platforms