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Biologics development: Are you making it more complicated than it needs to be?
9 months* to IND/IMPD submission and Phase I clinical trials
Present-day biologics development is considered inherently complicated, unpredictable, and costly. Speed to market is often the key factor in determining success or failure, yet it can often feel like a never-ending journey.
But what if that’s just an outdated thought?
Thermo Fisher Scientific’s new Path to IND for biologics platform was designed to conquer these key challenges head-on—fundamentally changing the game for drug developers in the biopharma space.
By providing titer levels of up to 8 g/L* for complex molecules like Fc-fusion and bispecifics, state-of-the-art equipment, cutting-edge software, and access to the depth and breadth of our resources—including raw materials and CRO services—we don’t just develop your biologic. We get you ready for Phase I clinical trials, funding and all, in as few as 9 months.*
Discover the reality behind these common misconceptions:
Misconception 1
I can't begin clinical trials until I receive IND/IMPD approval, which may delay demonstrating efficacy and advancing therapeutic use for patients.
Actually, you can. Australia and New Zealand do not require IND/IMPD approval to commence Phase I clinical trials. All you need is access to resources and experts in these countries, plus a fully developed drug product. Then, you’re ready to go.
By partnering with Thermo Fisher Scientific, you can leverage our global state-of-the-art sites and services for drug substance and drug product development, as well as clinical trial services. In fact, our new Path to IND for biologics platform estimates a timeline for DNA to simultaneous IND/IMPD submission and initiation of Phase I clinical trials in as few as 9 months for IgG1 and IgG4, and as few as 13 months for complex monoclonal antibodies, such as Fc-fusion and bispecifics (2024).*
Even better? Results of Phase I clinical trials can then be leveraged and included in your IND/IMPD filing—which we will do for you—and can potentially result in a higher chance of IND/IMPD approval.
Misconception 2
New technologies are unknown and, therefore, may be unreliable and hard to troubleshoot—leading to delayed or missed milestones.
Or are they? New technologies are engineered to fuel biologics development. Key experts in the industry have already developed cutting-edge technologies, such as:
- AI/ML vector construction and transposase integration
- The Beacon ® optofluidic system
- Ambr ® 15 and 250 systems
- Single-use technology (S.U.T.), such as 5,000 L bioreactors
- Multi-attribute modeling (MAM)
With these innovative platforms, biologics development is not only faster, but it’s also uncomplicated. Save money and resources by partnering with Thermo Fisher Scientific—a CDMO with industry-leading experts who leverage the technologies listed above to create optimized platforms, such as our new Path to IND for biologics, offering reduced timelines, high product quality, and improved yield.
Misconception 3
When partnering with a CDMO, I’ll have to pay royalty fees and will lose control over the portability of the cell line.
Unlike some CDMOs, Thermo Fisher does not charge royalty fees on the cell lines or manufacturing processes we help you develop. Although we can partner with you from discovery through commercialization, we know that isn't always practical. With Thermo Fisher, you don’t need to worry about losing control over your intellectual property or the portability of your cell line. We provide full portability. The cell line we develop for you will remain yours, allowing you to move it between manufacturing sites or continue development independently, without being locked into a single-source provider. This means greater flexibility for your business, no matter where your product journey takes you.
When you partner with us, you get exactly what you pay for—a custom-built solution that is yours to control and use as you see fit. Our focus is on empowering your success, not imposing extra charges after the fact.
Misconception 4
I need multiple CDMO partners so I can work with the top experts across each CDMO to complete the phase or milestone they are known for, ensuring success from the start.
Partnering with multiple CDMOs is not necessary to achieve development and production goals. This notion often stems from the perception that different partners are needed for specific stages or expertise. However, at Thermo Fisher Scientific, we offer a comprehensive suite of services that covers every aspect of your project, from early-stage research to commercial-scale manufacturing—without the need for multiple partners. Additionally, by acquiring top CDMO companies like Patheon and PPD, we ensure only the "best of the best" for our clients.
Thermo Fisher Scientific allows you to achieve your goals with just one partner. By combining our broad capabilities, expertise, and resources, we ensure that every phase of your project is handled with precision and care.
Misconception 5
Drug development service providers are not engines for innovation.
Some believe that CDMO partners merely execute pre-established processes rather than contributing to the creation of novel solutions. At Thermo Fisher Scientific, we pride ourselves on being at the forefront of innovation, driving breakthroughs at every stage of the drug development process. We do this by continually investing in cutting-edge technologies and state-of-the-art equipment, and by recruiting and retaining leading experts in the drug development field.
A great example of this is our new Path to IND for biologics platform. Our bioprocessing team of experts created a novel platform, leveraging transposase technology and the robust CHO-K1 cell line to achieve high molecule concentration levels of up to 8 g/L*. But we don’t just develop high-concentration biologics. We get you ready for simultaneous IND/IMPD submission and initiation of Phase I clinical trials, funding and all, in as few as 9 months.*
Misconception 6
Funding is difficult to get, especially given the current market conditions. Thus, programs are often delayed or unlikely to move forward at all.
It’s easy to think that securing funding for drug development is particularly difficult in today’s market conditions. While it’s true that funding challenges do exist, this should not be seen as an insurmountable barrier to progress.
At Thermo Fisher Scientific, we understand the complexities of funding in the current landscape and work closely with our clients to ensure that innovation moves forward—no matter the economic environment. Through our Thermo Fisher Financial Solutions, we can fully fund any or all of your biologic development programs from development through clinical trials and clinical manufacturing, offering flexible financial solutions designed just for you.
*Terms and Conditions: Titer levels provided are estimates based on third-party results and may vary depending on molecule type or other factors. The timeline from DNA to drug product and the start of clinical trials for all Path to IND for biologics options may vary depending on molecule type or other factors and are estimates to be finalized once third-party cell line development dates are available and confirmed. The 9-month timeline involves additional risk.