The FDA has observed an unprecedented increase in the number of cell and gene therapy products entering the early stages of development. In a recent statement, the agency outlined new planned policies to help accelerate these innovations through the pipeline to clinical success. We discuss what this announcement means to sponsors.
We are privileged to be working in collaboration with representatives of the Prion Alliance at the Broad Institute, on the development of a Prion ELISA. Why would we include this story in our blog? Well, it is because two aspects of this project are noteworthy; read on.
Methods for the detection of drug-induced antibodies have become much more sensitive, but the question remains to be answered: are antibodies at this low concentration level clinically relevant?
To keep up with the rapidly evolving field of drug development, we must stay on the pulse of bioanalytical innovation. Our latest blog summarizes some of the latest industry articles our team has found noteworthy.
Bioanalytical outsourcing has changed dramatically in the past 30 years, which isn’t surprising when you consider how our economy, the healthcare market, technology, and drugs themselves have changed in that same period. To fully understand how we have arrived, as an industry, at a place where outsourcing is vital to our collective success, it is helpful to look back at where we started.
Finding the right talent is challenging for any organization in any industry, but when you work in a complex field that requires highly skilled workers, it can be even more difficult. BioAgilytix’s CEO discusses the critical nature of hiring for a CRO, and approaches to attracting and retaining top scientific talent in a competitive industry.
It is anticipated that biologics will comprise 50% of the top 100 drugs by 2021. But, given the structural complexities of large molecule drugs, adherence to stringent quality standards will be a necessary part of effectively bringing these innovations to market. We discuss why it will be essential for pharma and biotech companies to align with outsourced partners that can deliver the quality science large molecule bioanalysis demands.
Our team recently attended the 14th Annual PEGS Summit to participate in discussions around advancements in biotherapeutic protein drug development and how they impact the work we do with large molecule biologics. From improving efficacy of CAR-T cell therapies to managing the challenges of immunogenicity testing, we’ve summarized the most compelling insights we gained at this year’s event.
Scientists from BioAgilytix recently attended the 12th WRIB in Philadelphia, PA. Meeting new contacts in the industry and taking part in discussions concerning the most innovative topics in bioanalysis, biomarkers, and immunogenicity was a genuinely valuable and enjoyable experience. We recap the topics that our team found to be most interesting at WRIB this year.
BioAgilytix is committed to keeping on the pulse of bioanalytical innovation across the pharmaceutical and biotechnology industries. To that end, we’d like to share some of the industry headlines we’ve been most interested in recently.
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