All CRO laboratories are not created equal. Each has different areas of focus and specialization, from those with broad-ranging capabilities to niche services. If you are looking for outsourced support for a large molecule program, you have to consider the complex nature of biologics, which makes their development and production processes challenging. Unlike small-molecule drugs, biologics are comprised of many heterogeneous molecules and are produced in living cell culture, which makes them much more difficult to control; even the slightest changes can have a significant impact on the drug’s efficacy and/or safety. Because of this, highly skilled personnel and high-quality methods and tools are needed, providing a solid bioanalytical foundation that will ultimately support efficient market approvals.

When evaluating CRO laboratories as potential partners in large molecule drug development, it will be important to consider these factors:

1. What level of access will you have to specialized expertise?
To ensure study success, a seasoned bioanalytical team is of the utmost importance, but who will actually be supporting your project day-to-day? The reality with outsourcing is that a CRO lab can introduce you to their most experienced scientific leaders at the start, but those experts are not providing active in-lab oversight once the project begins. That is why it is critical to evaluate the level of bench experience across the CRO’s team, and to ask the right questions regarding their project management approach. Do you they have the necessary depth of scientific expertise from having worked on like studies, and can they apply those learnings in creative ways to advance your novel program? Are they able to give you their ‘A’ team with leadership from and ready access to senior scientists throughout your study? Will the partnership be a collaborative and transparent one?

2. Can they uphold continuity across your project phases?
Because of the sensitive nature of biologic drugs, program continuity is an equally important area to consider so as not to compromise bioanalytical results. Continuity stems from two key areas: team retention and capacity. If a study is constantly changing hands among the CRO’s team as scientists leave, the room for confusion and error increases. And with large molecule projects often spanning years, constant CRO team turnover can have a significant negative impact on quality. Ask the CRO laboratories you are assessing about their employee retention rate – ideally, they will have a stable team and instill confidence that you will have consistent points of contact for your project from start to finish.

Capacity should also be considered since having a large molecule project change hands among multiple CROs also brings quality risks. A better approach would be to select a bioanalytical laboratory that can handle the full breadth of your study requirements. Do they have the capabilities to progress your therapeutic candidate through the phases of development, from preclinical work to sample analysis? If your study spans continents, will you have localized access to lab locations in multiple geographies and countries? And is the CRO able to multiply the productivity of their team with technology platforms to increase analysis capacity, automate assay procedures, and speed time-to-results?

3. What is their regulatory track record?
At the end of the day, your goal is to bring a new therapy to market in the most timely manner – one that is safe, effective, and addresses patients’ needs to give them hope for better health. Your bioanalytical data, therefore, must be robust, precise, reliable, and obtained in alignment with the appropriate regulatory standards. That is why it is imperative that your CRO laboratory of choice has a strong track record of compliance with bodies like the US FDA and EMA. With the right GxP knowledge to tap, you can make the most efficient “go/no-go” decisions and give your biologic the best chance for approval. Any studies to derive data capable of providing insights on patient-specific results, such as those for gene and cell therapy programs, also require US labs to have CLIA certification.

considerations in assessing cro laboratories

Make the Right Choice Among CRO Laboratories

Through careful evaluation, you will be able to find the CRO partner that checks all of these boxes and more – a partner like BioAgilytix. Did you know?:

  • BioAgilytix’s team is comprised of over 50% Ph.D. and Masters-level scientists, averaging more than 10 years of post-schooling bench experience. Our Bioanalytical Project Manager (BPM) model ensures your project is overseen each day by our most seasoned scientists, who provide active support to effectively guide your team through complexities both in and out of the lab.
  • BioAgilytix has a 90%+ employee retention rate – the highest in the industry. That means you’ll have project continuity with the same team committed to your study from start to finish. And, with advanced laboratory facilities and platforms in North Carolina and Boston, as well as in Hamburg, Germany, we are able to support all phases of large molecule global studies.
  • BioAgilytix supported more than 40% of the biologic drugs approved by the FDA from 2018 through 2019. Those results are not possible without a stellar regulatory track record.

At BioAgilytix, we understand the importance of getting your much-needed therapies to market quickly, which is why so many of sponsors consistently rely on us as their trusted CRO for high-quality bioanalysis. Learn how our scientific experts can help you with your biologic project by scheduling a one-on-one conversation here.