Lonza Expands DNA-To-IND Pathway For Complex Biologics
By Elizabeth Urbanek, Executive Editor
Lonza has expanded its accelerated DNA-to-Investigational New Drug (IND) development offering to include bispecific antibodies, Fc-fusion proteins, and high-concentration formulations. The program integrates drug substance and drug product development and manufacturing, with the company reporting potential IND readiness in as little as six months.
The expansion, announced October 13, extends Lonza's accelerated DNA-to-IND pathways for monoclonal antibodies to additional biologic formats. The program combines cell line development, formulation development, analytical methods, and drug substance and drug product manufacturing within one coordinated workflow.
Lonza says the expanded offering can deliver toxicology drug substance in as little as three months and IND readiness in as little as six months. These timelines are potential outcomes, not guaranteed schedules for every molecule.
The approach incorporates Lonza's GS Ori-Go vector technology and GS Gene Expression System, along with the company's experience in biologics development and manufacturing. Lonza says the integrated workflow is intended to help developers progress complex biologics toward clinical evaluation while addressing manufacturability and formulation requirements earlier in development.
The announcement does not identify a specific sponsor program that has achieved the stated timelines or quantify reductions in development time compared with conventional approaches.
What This Means For Clinical Supply
For clinical supply teams, accelerating the path to IND readiness can compress the time available to coordinate manufacturing milestones, analytical development, formulation decisions, and material availability.
Integrating drug substance and drug product activities within one program may provide earlier visibility into dependencies between development stages. However, the availability of toxicology material is not equivalent to having clinical trial material ready for release and distribution. Sponsors must still align manufacturing and testing activities with the requirements of the product and planned study.
High-concentration formulations also make early drug product decisions particularly relevant. Formulation requirements can affect the development and manufacturing approach, so changes or unresolved questions may have implications for the timing of clinical material availability.
Sponsors considering an accelerated pathway would need to establish which milestones can proceed in parallel, which decisions are required before manufacturing can advance, and how development timelines align with planned clinical study start dates.
The announcement does not establish whether the pathway reduces clinical supply delays, changes batch-release timelines, or improves distribution readiness. Those outcomes would depend on the individual program and how its development activities are coordinated.
For sponsors, the operational consideration is whether an integrated development pathway provides sufficient visibility into material readiness to support clinical planning without creating new dependencies or unrealistic timeline expectations.
The Supply Question
How can sponsors align drug substance, formulation, analytical development, and drug product manufacturing milestones to ensure clinical material is ready when a study needs it?
Related Clinical Supply Leader Readings
- How To Build Clinical Supply Into Drug Development From The Start
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About The Author:
Elizabeth Urbanek is the Executive Editor for Clinical Supply Leader, where she works with clinical trial supply and logistics professionals across pharma and biotech to bring real-world perspectives, operational challenges, trends, scientific insights and regulatory strategy to the field.
Before joining life sciences media, Elizabeth spent more than 15 years in broadcast, digital and live-event storytelling, helping highly technical teams communicate complex ideas with clarity and impact. She brings that same approach to clinical supply, creating editorial space for experts to share what is happening across clinical trial operations.
Elizabeth is passionate about connecting people and ideas, identifying emerging themes and showcasing work that can move the clinical supply field forward.