For biotech and pharma companies advancing monoclonal antibody programs, the pressure to reach the clinic quickly has never been greater. But speed alone isn’t enough—early decisions made during IND-enabling stages can significantly impact long-term timelines, therapeutic quality, costs, and scalability.
Too often, early development and manufacturing are treated as a series of disconnected handoffs rather than a unified strategy. While this approach may get programs to IND, it can create downstream challenges when scaling processes, transferring technologies, or expanding supply.
As a result, many teams are asking a critical question: how can we move fast today without creating delays tomorrow?
A more effective path forward starts with integration—aligning development and manufacturing from the outset and connecting them to a broader global network that supports long-term success.
The risk of disconnected early-phase strategies
In early-phase biologics development, fragmentation can quietly erode progress. When cell line development, process development, analytical characterization, and manufacturing are spread across disconnected partners or systems, even minor handoff issues can create meaningful downstream delays.
That risk is amplified by today’s compressed timelines. Peer-reviewed analyses show that lead monoclonal antibodies (mAb) to Phase 1 IND timelines are now often 10–12 months, compared with roughly 18 months several years ago—leaving far less room for avoidable rework¹².
Manufacturing changes introduced later in development can add further complexity. Research shows that comparability assessments may require analytical, preclinical, and sometimes clinical studies, and one published example reported three comparability studies per molecule for two IgG1 programs as process changes were introduced over time³⁴.
The result is a slower, more complex path to clinic—exactly when speed, consistency, and scalability matter most⁵.
A more strategic path to IND
An integrated Path to IND approach addresses these challenges by bringing together development and early manufacturing within a single, coordinated framework. By aligning cell line development, process development, and clinical manufacturing early, companies can build a stronger, more scalable foundation for their programs.
This approach reduces rework, improves data continuity, and streamlines regulatory documentation—helping teams move more efficiently from development into clinical manufacturing. Just as importantly, it creates a consistent platform that can extend across multiple manufacturing sites as programs grow.
Expanding beyond a single-site mindset
As demand for biologics manufacturing continues to rise, relying on a single site can limit flexibility and increase risk. Capacity constraints, supply chain considerations, and the need for geographic redundancy are driving more companies to adopt multi-site strategies earlier in development.
However, adding a second site has traditionally introduced complexity—requiring new systems, process adjustments, and extensive comparability work that can delay progress.
A more forward-looking approach connects sites from the beginning, enabling programs to scale across locations without starting over.
New US facility expansion supporting a connected network
Thermo Fisher Scientific’s continued investments reflect this shift toward integrated, multi-site strategies. At the center is the future expansion of the Plainville, Massachusetts campus, which will add GMP drug substance manufacturing for protein-based biologics, including monoclonal antibodies, bispecifics, and Fc-fusion proteins, to its existing mRNA and gene-therapy based manufacturing and sterile fill-finish capabilities toward the end of 2026.
This future expansion creates a fully US-based option for both biologic and sterile fill-finish GMP manufacturing, supporting companies prioritizing domestic supply and streamlined regulatory pathways. The site will also include a bioprocess design center, offering training and technical expertise to support process development.
Importantly, the Plainville campus is not a standalone solution—it is part of a broader, globally connected network designed to support programs from early development through commercialization.
The advantage of a connected global network
Within Thermo Fisher’s biologics network, sites such as St. Louis, Missouri, and Groningen, Netherlands are aligned through shared systems, standardized equipment, and harmonized processes. These sites already support early-phase biologics manufacturing and operate within the same global framework as Plainville.
This alignment enables more seamless technology transfer, consistent data and quality standards, and a faster path to establishing additional manufacturing capacity. Rather than introducing complexity, adding a second site becomes a natural extension of the original development strategy.
For drug developers, this means greater flexibility to access capacity where and when it’s needed—without the delays typically associated with cross-site transitions.
Turning integration into a competitive advantage
Following Thermo Fisher’s model, by combining an integrated Path to IND for biologics approach with a globally connected manufacturing network, companies can build programs designed for both speed and long-term success.
This model allows teams to start development with scalability in mind, reduce redundant work, and maintain consistency from early development through clinical manufacturing. It also provides the flexibility to adapt as program needs evolve—whether by accessing additional capacity, expanding geographically, or preparing for later-stage production.
A smarter way to move forward
In today’s environment, success isn’t just about reaching IND—it’s about doing so in a way that positions the entire program for what comes next.
An integrated, network-driven approach gives drug developers the ability to move quickly without sacrificing scalability, reduce risk without limiting flexibility, and build a foundation that supports growth from DNA to commercialization.
For companies advancing protein-based biologics, rethinking the path to IND isn’t just an operational decision—it’s a strategic advantage.
Explore how Thermo Fisher Scientific’s Path to IND solution can support your program from early development through clinical manufacturing—[learn more here].
References
- Kelley B. Developing therapeutic monoclonal antibodies at pandemic pace. Nat Biotechnol. 2020 May;38(5):540-545. doi: 10.1038/s41587-020-0512-5. PMID: 32317764; PMCID: PMC7173776.
- Warr SR, Patel J, Ho R, Newell KV. Use of Micro Bioreactor systems to streamline cell line evaluation and upstream process development for monoclonal antibody production. BMC Proc. 2011 Nov 22;5 Suppl 8(Suppl 8):P14. doi: 10.1186/1753-6561-5-S8-P14. PMID: 22373478; PMCID: PMC3284950.
- Chirino AJ, Mire-Sluis A. Characterizing biological products and assessing comparability following manufacturing changes. Nat Biotechnol. 2004 Nov;22(11):1383-91. doi: 10.1038/nbt1030. PMID: 15529163.
- Lubiniecki A, Volkin DB, Federici M, Bond MD, Nedved ML, Hendricks L, Mehndiratta P, Bruner M, Burman S, Dalmonte P, Kline J, Ni A, Panek ME, Pikounis B, Powers G, Vafa O, Siegel R. Comparability assessments of process and product changes made during development of two different monoclonal antibodies. Biologicals. 2011 Jan;39(1):9-22. doi: 10.1016/j.biologicals.2010.08.004. Epub 2010 Oct 14. PMID: 20888784. 5. Kochanowski N, Malphettes L. Technology transfer and scale down model development strategy for biotherapeutics produced in mammalian cells. BMC Proc. 2013 Dec 4;7(Suppl 6):P86. doi: 10.1186/1753-6561-7-S6-P86. PMCID: PMC3981586.
