As a university researcher, you’ll no doubt reach a point where you want to translate basic discoveries made in the lab to practical applications in a clinical setting. In fact, more than one-third of new cancer medicines had contributions from an academic inventor like you.
But a university or medical center lab is much different from a clinical manufacturing environment where current good manufacturing practices (cGMP) are required. You’ll need support to move that promising research from the lab to a cGMP setting.
Partnering with an experienced biologics contract development and manufacturing organization (CDMO) is essential to advancing your research from a university lab to phase I clinical trials and beyond. How can you make this happen?
Since few university or medical campuses are equipped for cGMP manufacturing, translating your research to clinical trials WILL require a third-party partner. Almost all successful biologics on the market rely on a CDMO to make them—even the groundbreaking COVID-19 vaccines were not manufactured by the Big Pharma companies that own them.
“Some basic researchers don’t really connect their research to translation. Bringing an innovation entrepreneurial mindset to life science academic research increases the potential to bring more products to market.”
~ Dr. Kenneth Eilertson, Pennington Biomedical Research Center, on the Bio from the Bayou podcast.
For those new to scaling up to clinical manufacturing, it’s important to avoid common pitfalls of translational research. Here are some valuable pointers about the process:
Get support for scaling process development
Scaling up from shake flasks in the lab to cGMP bioreactors for clinical phase production is extremely complex. You’ll need a robust process optimized for clinical and, eventually, commercial manufacturing. You can lean on a CDMO partner to help you with that process development work.
Expect challenges during tech transfer
The tech transfer from your lab to a CDMO is critical to getting your clinical manufacturing program off to a good start. You should expect the unexpected, and ensure your CDMO helps you budget your time and finances accordingly. Before you choose a CDMO, make sure you find a partner who will dedicate a program manager to oversee your entire scope of work. This program manager will be especially critical during tech transfer, and will guide you through the documentation needed to kick off your program.
Find a partner who can work within your budget and timeline
Translating research from a university lab or an academic medical research center to phase I clinical trial manufacturing does not typically involve venture capital. Funding most often comes from grants and other non-dilutive funding mechanisms (a topic we’ll cover in a future article). Because funding is finite, and it typically comes with specific timelines in which that funding needs to be spent, make sure your CDMO prioritizes your project. Small-volume and early-stage programs don’t need to take a backseat to a Big Pharma client with much higher billings, or put you at risk with lowest-price outsourcing partners.
Building a successful business and technical relationship with a CDMO starts with finding the right outsourcing partner. While certain qualities are table stakes for any CDMO worth its salt—technical capabilities, experience with regulatory authorities, and a robust quality program—not all CDMOs are the same. Two of the main variables in your choice will be location and size, as they significantly affect service.
Finding a U.S.-based CDMO matters because proximity promotes collaboration. Additionally, funding from the NIH or other U.S. or state government program usually stipulates that you have to work with domestic service providers.
Large CDMO business models typically favor large, late-stage programs and may not be the best option for small-volume or early phase programs. An early-stage program might get their “B” team. Think of it as a classroom: Would you rather be crowded into a large, entry-level lecture hall where your instruction comes from a TA who just started grad school? Or would you rather advance your program through clinical trials with more hands-on, personalized help from a team of tenured professors? Choosing a smaller, boutique biologics CDMO gives you the equivalent of a team of PhD experts who will treat your program like it’s their own research.
The great thing about working with a CDMO is you’ll only have to help with the science; your CDMO should take care of the rest. An ideal CDMO will be well-versed in all regulatory guidelines and will ensure your program follows cGMP. They’ll help procure necessary starting materials and consumables to run your program and ensure their staff is trained on all equipment and technology needed to manufacture your biologic. And they’ll assign you a program manager to ensure timely communication and oversee deadlines and deliverables.
In short, a boutique CDMO is much more than a service provider you pay to manufacture your biologic drug substance for clinical trials. They’re one of the most important partners to ensure your success. Your CDMO partner will also:
To transition from the bench to the clinic, and find the right outsourcing partner, it’s all about networking, networking, networking. Where can you turn for advice about biomanufacturing and choosing a biologics CDMO?
Translational research isn’t for the faint of heart, but the reward of seeing your scientific expertise benefit patients and their families is worth the effort. Engaging a CDMO at the beginning of the biomanufacturing process can inform early choices about budget, timelines, tech transfers, and process development that can help to avoid missteps downstream. The RFP and contracting process always takes longer than you think, so start it now.
Contact us to learn more
Contact Scorpius to discuss your next mammalian or microbial program and learn why a boutique biologics CDMO can help you advance through the clinic quickly, affordably, and safely.