CMC Predictions for the 5th Novel Conjugates Summit 

As I look ahead to the 5th Novel Conjugates Summit, I’m struck by how quickly the conversation around conjugates continues to evolve. The agenda reflects a field that is expanding across formats, payloads, and therapeutic areas, but also one that is becoming more thoughtful about how these increasingly complex molecules are actually developed and delivered  

Heading into this year’s meeting, I see three themes that feel especially important to watch, not just from a scientific perspective, but from a development and CMC lens as well. 

Prediction 1: Converging Payload Modalities 

One of the clearest shifts across the space is the growing diversity of payload strategies being explored. Rather than converging around a single approach, the field is embracing a broader toolkit that includes peptides, oligonucleotides, chelators, and small molecules, each bringing its own considerations. 

Among these, chelator-antibody conjugates stand out as an area where I expect particularly thoughtful discussion. These constructs introduce an added layer of complexity, especially when it comes to incorporating radio isotopes after conjugation to create the radioimmune conjugate product. That sequencing requires careful orchestration, as the conjugated antibody must remain stable while still enabling efficient downstream labeling. 

This dynamic changes how teams think about process design and control strategies. It reinforces the idea that conjugation is no longer a single step, but part of a broader workflow that extends through final product preparation. As more programs move into this space, I expect conversations to focus increasingly on robustness, scalability, and operational flexibility. 

More broadly, the convergence of peptides, oligos, and small molecules with antibody platforms reflects a larger trend: payload selection is becoming more intentional and more closely aligned with the biology being targeted. 

Prediction 2: Lifecycle Readiness 

As conjugates grow more sophisticated, I’m seeing more emphasis on understanding the full lifecycle of the molecule, not just the final product, but every intermediate along the way. 

That includes the progression from naked recombinant protein or antibody, through drug substance intermediates, to conjugated protein drug substance, drug product intermediate, and ultimately final drug product. Each stage brings its own considerations around characterization, control strategy, and documentation, and each plays a role in shaping the overall regulatory narrative. 

Due to the complexity of new and emerging bio-conjugates, an important consideration prior to tech transfer of the process from a client (the sponsor) and during  process development by a CDMO is adequate risk assessment of the entire process which may involve multi-step conjugation process that results in a composite of the target, recombinant protein, linker and payload. This will result in a compliant, scalable and economical process. 

I expect more discussion around how teams are defining specifications and standards across these stages, particularly as programs advance toward regulatory submissions like INDs and BLAs. The ability to clearly articulate how the molecule evolves throughout development, and how consistency is maintained, is becoming just as important as the underlying science itself. 

Prediction 3: Integrated Operating Models  

The growing complexity of conjugates is also reshaping how development programs are structured operationally. Bringing these therapies forward requires coordination across a wide range of capabilities, from recombinant protein and antibody production to conjugation, analytical testing, and final fill-finish. 

One of the most interesting dynamics to watch is how organizations are bridging supply chain gaps across these steps. This often involves partnerships with upstream cell culture providers alongside the integration of chemically synthesized or commercially available linkers and payload components. Aligning timelines, quality expectations, and technical requirements across these inputs is becoming a critical success factor. 

In parallel, multisite regulatory strategies are becoming more common, requiring careful coordination to ensure consistency across manufacturing locations and development partners. Rather than viewing each step in isolation, the focus is increasingly on creating a connected ecosystem that supports the molecule from early development through commercialization. 

Looking Ahead 

What makes this year’s summit particularly compelling is the sense that the field is moving into a new phase of maturity. Innovation remains strong, but there is growing attention on how to translate that innovation into practical, scalable solutions. 

Across payload integration, lifecycle readiness, and operating model evolution, the common thread is a shift toward holistic thinking. I expect these themes to shape not only the discussions at the meeting, but also how programs are designed in the years ahead. 

Click here, to get connected or schedule a meeting with me and GBI’s SME on Bioconjugation at the 5^th Annual Novel Conjugates Summit to further discuss innovation and growth! 

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