From The Stage

BioAgilytix Team Q&A: Meet Christine Ford, Corporate Compliance Manager

Posted by / / BioAgilytix Insight, CRO Selection

For BioAgilytix, committed, engaged, and talented employees have been pivotal to our success since the founding of our company. To give you additional insight into how BioAgilytix’s premier science is supported by the best people, we’ve asked members of our Scientific, Quality Assurance (QA), and Quality Control (QC) teams to share their experiences firsthand. Today we talk to Christine Ford, Corporate Compliance Manager at BioAgilytix’s North Carolina laboratory, to discuss with her what it’s like working in Quality Assurance in a rapidly changing environment. Tell us a little about your…

BioAgilytix Team Q&A: Meet Jessica Rohrman, Scientist II and Bioanalytical Project Manager

Posted by / / BioAgilytix Insight, CRO Selection

The best science demands the best people, and we believe the individuals that work at BioAgilytix are truly the top of the field. Their expertise and unwavering commitment to helping our customers meet their study goals drives the quality of bioanalytical services we deliver every day. Our employees’ perspectives are an important part of understanding BioAgilytix as a company. As such, we sat down and talked with members of the Scientific, Quality Assurance (QA), and Quality Control (QC) teams to help you learn more about them – since they are…

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.…

Outsourcing Bioanalysis: An Opportunity to Enhance Your Large Molecule Development Strategy

Posted by / / BioAgilytix Insight, CRO Selection

The biologics market is rapidly growing, resulting in increased demands on pharmaceutical and biotech companies to produce novel biologics more quickly. In the past, many companies chose to handle drug development and production internally with an in-house team of scientists. However, with increased competition, restricted timeframes, and capacity challenges, it has become necessary for a majority of pharmaceutical and biotech companies, regardless of their size, to consider using CROs as a solution for more efficient development and production. Deciding to outsource has the potential to positively influence the outcome of…

BioAgilytix: Taking Action to Guide Effective Biosimilar Development

Posted by / / BioAgilytix Insight, Biosimilars

The global market for biosimilars is expected to grow at an exponential rate in coming years, from only $3 billion in 2016 to a forecasted $10 billion by 2021. So, it is not a surprise that biosimilar development has continued to be a hot topic in our industry in 2017, particularly related to regulation. To secure regulatory approval for a biosimilar, the manufacturer must demonstrate that the biological product is highly similar to its reference biological product, with no clinically meaningful differences in safety, purity, and potency. But, neither FDA…

Managing Diverse Bioanalytical Talent in an Evolving Industry

Posted by / / BioAgilytix Insight, Industry Update

Great people are the foundation of any successful company, and particularly when it comes to bioanalysis. Laboratories critically need the right blend of talent—including not just scientists, but also quality personnel, project leaders, etc.— to produce high quality bioanalytical results for their clients. But our ever-evolving field, combined with the realities of today’s job market and increasingly discerning preferences of job seekers and employees, can make talent management a challenge. So what practices are leading CROs using to attract, retain, and enrich talent today? Recruiting the best new people, while…