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Dr. Afshin Safavi
Posted by Dr. Afshin Safavi BioAgilytix Insight, CRO Selection

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

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

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 a study, especially when working with the right CRO. Read on to learn more about why outsourcing your large molecule projects with a dependable CRO like BioAgilytix can be a value-add for your study.

Access Specialized Expertise
When beginning a project, it is important to decide how outsourcing will fit into your overall plan. Making this decision should begin with comparing your organization’s core competencies against those you need for the study, and those of potential CRO partners. Especially when it comes to large molecule bioanalysis, you want the team that has the most experience with your given type of project, as they will be able to anticipate and, in turn, proactively address scientific and regulatory challenges that are likely to arise in these complicated studies. Understanding the intricate ins and outs of regulatory approval processes is also a vital part of getting a drug to market efficiently. If that is not your own in-house team, outsourcing to a CRO who does have that expertise will only benefit your final outcome.

Instantly Increase Your Capacity
Having the right type of facility, as well enough bandwidth to efficiently advance a study through its phases, can often be a roadblock for pharmaceutical and biotechnology companies working on a new project—especially one with an aggressive timeline. Depending on other ongoing projects, existing capacity may be occupied with other high priority projects. In this scenario, outsourcing is a smart way to immediately increase capacity without increasing the overhead or time required to build out more laboratory or manufacturing space. You will also be able to gain access to a different portfolio of platforms and instrumentation that the CRO maintains, which may not be available or feasible to implement in your own laboratory environment.

Choosing the Right CRO
If it is determined that outsourcing would be the best solution for your project, choosing the best-fit CRO is the next challenge. Ideally, you should look for an organization that embodies all of the qualities and resources above and can also manage your project end to end, keeping the management team contiguous throughout the entire process.

As a CRO that has specialized in only large molecule bioanalysis since our founding nearly 10 years ago, BioAgilytix today is a top 4 bioanalytical laboratory for large molecule bioanalysis globally. We’ve supported a diverse range of biomarker, immunogenicity, PK, and cell-based assay studies over that time, and are well-versed in how to navigate their wide-ranging complexities. In fact, our scientists actively work alongside our customers and regulatory agencies to help shape the approaches and guidance that are driving new innovation is these fields, to progress development of much-needed novel biologics. Our collective insight enables us to efficiently guide studies to deliver high-quality results, on time, and ultimately help our customers accelerate time to market.

We have also continued to strategically expand overall capacity at both our European and USA laboratories to ensure we have the resources to support projects with demanding timelines, including large Phase III studies and studies requiring sample analysis of large sample numbers. This effort includes careful investment in new platform technologies that have proven to support delivery of accurate, rapid results.

Although these elements are very important, at the end of the day, successful outsourcing is driven by the quality of partnership you build with your CRO. BioAgilytix has an industry-leading employee retention rate, virtually ensuring that the same bioanalytical project team will conduct your study from beginning to end. We are unmatched in our commitment to producing quality end results for each of our clients while keeping you in scope and within your designated timeframe through an open, collaborative approach and efficient project management.

Interested in discussing more of the benefits of outsourcing your large molecule project? See how BioAgilytix can be your ideal CRO partner by speaking to one of our scientists today.

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