From The Stage

BioAgilytix Team Q&A: Meet Angela Daniels, QC Specialist IV

Posted by / / BioAgilytix Insight, CRO Selection

For any bioanalytical lab, people are the most valuable resource; but for BioAgilytix, it is the passion that our people bring to their work each day that helps truly set our science and services apart. We want to give you more insight into the people behind our science, so we’ve been sitting down with members of our Scientific, Quality Assurance (QA), and Quality Control (QC) teams so they can share their experiences firsthand. Today we talk with Angela Daniels, QC Specialist IV at BioAgilytix’s North Carolina laboratory, to gain her…

Influencers in the Assessment of Immunogenicity Part 2: Immunogenicity of Biosimilars

Posted by / / Biosimilars, Immunogenicity

An increasing number of patents for originator biologic products are due to expire, and therefore opportunity within the industry to develop additional biosimilars is growing. In response, more pieces of relevant guidance are being developed, and the increased knowledge being gained by the industry as a whole will continue to inform best practices in evolving biosimilar development processes, including those for immunogenicity testing. According to most recent FDA and EMA guidances, a biosimilar is a biological product that is highly similar to an already authorized original biological medicinal product (reference…

How Engaging Bioanalytical Talent Closes Continuity Gaps in Studies

Posted by / / BioAgilytix Insight, CRO Selection

Continuity is an important factor in the success of a bioanalytical research study. Project handoffs between teams and/or individuals in the middle of development create knowledge gaps, which increase room for error and may ultimately result in timeline delays. That means CROs must continually focus on cultivating their most important resource—their people—to ensure they not only have the scientific skills to see a project through from start to finish, but that they also feel confident, content, appropriately challenged, and valued in their roles. In a segment where employee turnover is…

Why Bioanalytical Technology Strategies Require an Analytical Approach

Posted by / / Bioanalytical Platforms, CRO Selection

The technology used to support your biotherapeutics development project can have a major impact on study outcomes. The right platforms can improve assay speed and accuracy to give you quality results, faster, while the wrong choice can leave you lacking robust, reproducible data. With a plethora of advanced platform options available in the market today, it can be difficult for CROs to determine where to focus their investment, and for sponsors to know what to look for in a CRO partner’s platform portfolio. That is why analytical assessment is needed.…