Lonza Expands DNA-to-IND Offering for Complex Biologics

Lonza has expanded its accelerated DNA-to-Investigational New Drug (IND) offering beyond monoclonal antibodies (mAbs), enabling developers of more complex biologics, including bispecific antibodies, Fc-fusion proteins, and high-concentration drug product formulations, to reach key development milestones faster.

The enhanced platform is designed to help biopharmaceutical companies accelerate the path from DNA sequence to clinical evaluation, addressing growing industry demand for advanced therapeutic formats that often present greater development and manufacturing challenges than traditional antibodies.

“Earlier this year, we introduced our accelerated DNA-to-IND pathway for monoclonal antibodies,” said 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.”

The expanded offering leverages Lonza’s integrated development model, combining its new GS Ori Go vectors, part of the GS Gene Expression System platform, with more than three decades of biologics development and manufacturing expertise. By applying prior knowledge and established development strategies from the earliest stages, Lonza aims to reduce risk, improve predictability, and accelerate progress toward clinical readiness.

Under the integrated program, drug substance and drug product development are managed through a coordinated framework designed to streamline early-stage development. Lonza said the pathway can deliver toxicology-grade drug substance in as little as three months and support IND readiness in approximately six months.

The company noted that while speed remains a critical objective, developers must also consider manufacturability, formulation requirements, and long-term scalability. To address these factors, the program combines cell line development, analytical testing, formulation development, and both drug substance and drug product manufacturing into a single development pathway.

A key component of the expanded offering is the earlier incorporation of high-concentration formulation development, an increasingly important consideration as drug developers pursue more patient-friendly administration methods and seek to overcome formulation challenges associated with complex biologic molecules.

“By integrating drug substance and drug product development into one coordinated pathway, we are helping customers address these evolving needs while progressing promising biologics toward the clinic with greater speed and confidence,” Bates added.

The expanded DNA-to-IND platform reflects a broader industry push to shorten development timelines while supporting increasingly sophisticated biologic drug candidates, enabling innovators to advance a wider range of therapies into clinical testing more efficiently.