Lonza, the world’s leading CDMO, announced today a strengthening of its biologics development services with an enhanced preclinical development offering designed to help customers make more confident early‑stage decisions while helping to accelerate timelines and reducing development risk. By combining early, decision‑enabling insights with accelerated execution, the enhanced approach addresses uncertainty at the point in the development journey where choices have a significant development impact, supporting stronger portfolio decisions and a clearer path to first‑in‑human studies, and beyond.

Building on Lonza’s established preclinical development expertise, the offering integrates development, manufacturing, and regulatory insight from the outset to help deliver faster, more predictable progress without compromising quality. The enhanced offering is strengthened by innovative enabling technologies, including the new GS Ori‑Go^™ vector technology. The technology is designed to help improve productivity and consistency in early‑stage biomanufacturing and builds on the industry‑leading GS Gene Expression System^®, which has supported over 100 commercial products. The launch reinforces Lonza’s commitment to de‑risking, acceleration, and innovation across biologics development. Combined with Lonza’s end-to-end development and manufacturing expertise, the DNA-to-IND program enables early-stage pharma and biotech companies to rapidly progress from early discovery to clinical readiness.

Early de‑risking where decisions matter most

Lonza’s new early de-risking package delivers data-driven, integrated insights across development, manufacturing, and regulatory processes to help reduce uncertainty at crucial early-stage decision points. By providing a comprehensive picture of safety, manufacturability, and regulatory readiness early on, the package contributes to providing early-phase companies and their stakeholders with greater confidence that the lead drug candidate they are advancing is both viable and scalable. This enables evidence-based candidate selection and establishes a more predictable path towards first-in-human studies.

Accelerated DNA‑to‑IND timelines without compromise

Lonza’s enhanced DNA‑to‑IND offering enables monoclonal antibody programs to achieve IND readiness in as little as six months, with toxicology‑grade drug substance available in approximately two months. Accelerated timelines are delivered through lean, streamlined process development and proven platform technologies, without compromising product quality or compliance standards.

GS Ori‑Go^™: evolved expression technology for faster, simpler IND pathways

As part of this enhanced offering, Lonza launched GS Ori-Go^™, a next-generation vector platform for the GS^®Expression System. This evolved technology is designed to further improve efficiency, consistency, and confidence in early‑stage biomanufacturing compared to the current GS^®expression system. The new vector technology supports lead-clone titers higher than 11 g/L  and allows direct progression from bulk pools to clonal cell lines, removing the need for enriched pools and methionine sulfoximine (MSX) selection. The platform demonstrates strong bulk pool stability and more than a 30% increase in titers across multiple modalities, including monoclonal antibodies, bispecifics, and fusion proteins¹. GS Ori-Go^™ enables faster development of high-quality cell lines with fewer steps, helping customers streamline workflows while maintaining strong performance and reliability¹.

By strengthening productivity and predictability early in development¹, the new GS Ori‑Go^™ vectors reinforce Lonza’s integrated approach to accelerating DNA‑to‑IND timelines while reducing downstream risk.

Raymond Donninger, Senior Director, Commercial Development, Integrated Biologics, Lonza, commented:“We know that the earliest decisions in biologics development are often the hardest and the most critical. With this enhanced DNA‑to‑IND offering, we’re helping our customers make those decisions sooner and with greater clarity, while bringing meaningful innovation to them faster. By combining early de‑risking, accelerated execution, and technologies like our new GS Ori‑Go^™ vectors, we’re enabling teams to progress high‑quality biologics programs to the clinic with greater speed, confidence, and control.”