Lonza is expanding its accelerated DNA-to-Investigational New Drug (IND) development offering beyond monoclonal antibodies (mAbs), adding support for more complex biologic formats as drug developers look to shorten the path from molecule design to clinical evaluation. The expanded offering covers bispecific antibodies, Fc-fusion proteins and high-concentration drug product formulations. It builds on the accelerated mAb development pathways the contract development and manufacturing organization (CDMO) introduced earlier this year.

Under the integrated development model, Lonza says toxicology drug substance can be delivered in as little as three months, with IND readiness achievable in as little as six months. Actual timelines will depend on the molecule, development requirements and program-specific considerations. The approach combines drug substance and drug product development within a coordinated program, bringing together cell line development, formulation development, analytical methods and manufacturing activities. The aim is to reduce handoffs between development stages while addressing manufacturability, formulation requirements and clinical readiness earlier in the process.

The expanded pathways use Lonza’s GS Ori Go vectors, which form part of its GS Gene Expression System platform. The company is also drawing on more than 30 years of experience in biologics development to apply established processes and prior knowledge at the outset of a program. According to Lonza, this strategy is intended to accelerate development while limiting risk and supporting more predictable outcomes. For complex biologics, where molecular characteristics can introduce additional development and manufacturing challenges, early consideration of these factors can be particularly important. The offering also brings high-concentration formulation development into earlier stages of the process. This is relevant for biologics programs in which formulation properties and administration requirements can influence the design of the drug product and its path toward clinical use.

The expansion reflects the need for development pathways that accommodate a broader range of biologic modalities, rather than focusing primarily on conventional monoclonal antibodies. “Earlier this year, we introduced our accelerated DNA-to-IND pathway for monoclonal antibodies,” says Gordon Bates, Head of Integrated Biologics at Lonza. “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.”

By bringing development and manufacturing activities into a single coordinated framework, Lonza aims to help biopharmaceutical companies advance complex biologic candidates toward IND submission with fewer delays between development stages. The company’s stated timelines position the offering as an option for developers seeking to accelerate early-stage programs while accounting for formulation and manufacturing considerations before clinical evaluation.

For more information, visit www.lonza.com.