Lonza, the world’s leading contract development and manufacturing organization (CDMO), announced the expansion of its accelerated  DNA–to-Investigational New Drug (IND) offering to support non-mAb biologics, including bispecific antibodies, Fc-fusion proteins and high-concentration drug product formulations.

Building on the faster DNA to IND pathways introduced for monoclonal antibodies (mAbs) earlier this year, the extended offering brings significantly reduced timelines to more complex biologic formats, helping innovators advance a broader range of molecules toward clinical evaluation faster than previously possible. The new pathways build on Lonza’s experience supporting the development of diverse biologic modalities across early development programs.

The offering is enabled by Lonza’s integrated development approach, combining new GS Ori Go® vectors, part of the industry-leading GS Gene Expression System® platform, with over 30 years of proven expertise. By applying proven, prior knowledge-based approaches from the outset, Lonza helps customers accelerate progress while minimizing development risk, and maintain confidence on development outcomes.
The integrated offering brings together drug substance and drug product development within a coordinated program framework, helping biopharmaceutical innovators move promising molecules toward IND readiness more efficiently. The pathway also enables the delivery of toxicology drug substance in as little as three months and IND readiness in as little as six months.

We recognize that developers must balance speed with manufacturability, formulation requirements and clinical readiness. Lonza’s approach integrates cell line development, formulation development, analytical methods, drug substance and drug product manufacturing, helping streamline early development while maintaining a focus on scalable, phase-appropriate outcomes.

The offering also incorporates high-concentration formulation development earlier in the process, supporting evolving administration needs and helping address formulation challenges commonly associated with complex biologics.

Gordon Bates, Head of Integrated Biologics, Lonza, commented: “Earlier this year, we introduced our accelerated DNA-to-IND pathway for monoclonal antibodies. With this latest enhancement, we are extending those reduced timelines to more complex biotherapeutic formats including bispecific antibodies, Fc-fusion proteins, as well as high-concentration formulations, for which we are seeing growing demand as developers pursue increasingly advanced therapies. By integrating drug substance and drug product development into one coordinated pathway, we are helping customers address these evolving needs while progressing together promising biologics toward the clinic with greater speed and confidence.”