From The Stage

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

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / 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

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / 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

Dr. Arno Kromminga
Posted by Dr. Arno Kromminga / / 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

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / 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

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / 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

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / 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…

Taking Action to Guide Effective Biosimilar Development

Dr. Dominique Gouty
Posted by Dr. Dominique Gouty / / 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

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / 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…

Platform Spotlight: Analyze Immunoassays on a Nanoliter Scale with Gyros

David Rusnak
Posted by David Rusnak / / BioAgilytix Insight, Bioanalytical Platforms

When it comes to large molecule bioanalysis, scientists often need to strike a delicate balance between data and time requirements: ensuring their results are as accurate and reproducible as possible, while doing so within aggressive or constraining timelines. Both sides must be upheld to avoid budget overruns or the chance that the data will be eventually rejected by regulatory agencies. Luckily, bioanalytical technology advancements are continually being made to address these pressures, and with the right platform scientific teams can more confidently deliver robust results, on time. One such example…

Investing in Emerging Bioanalytical Technologies: A Balancing Act

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Bioanalytical Platforms

Technology plays a critical part in everything we do as a bioanalytical laboratory. Ensuring that we have leading-edge platforms and instrumentation, as well as subject matter experts who can effectively operate them, are paramount concerns for our operation, so that we can capture and deliver robust, accurate scientific data in an efficient manner. When making technology purchasing decisions, there are a number of factors to consider – from cost to market needs to available talent. Each must be carefully weighed in order to maximize the ROI of any technology investments…