Days
Hours
Minutes
Seconds

Lonza Launches Enhanced DNA-to-IND Offering With Six-Month IND Timelines

COMPANY PROFILE
  • Lonza has expanded its biologics development services with an enhanced preclinical offering designed to support earlier decision-making, reduce development risk, and accelerate timelines.
  • The company also launched GS Ori-Go™, a next-generation vector platform that supports accelerated DNA-to-IND timelines and improved early-stage biomanufacturing productivity.

Lonza has announced an expansion of its biologics development services through an enhanced preclinical development offering aimed at helping pharmaceutical and biotechnology companies make earlier development decisions, reduce risk, and accelerate progress toward clinical studies. The CDMO said the approach combines development, manufacturing, and regulatory expertise from the outset to support more predictable biologics development.

The enhanced offering includes a strengthened DNA-to-IND program designed to help customers move from early discovery to clinical readiness. According to Lonza, monoclonal antibody programs can achieve investigational new drug (IND) readiness in as little as six months, with toxicology-grade drug substance available in approximately two months. The company said these timelines are supported by streamlined process development and platform technologies while maintaining quality and compliance standards.

As part of the announcement, Lonza introduced GS Ori-Go™, a new vector platform for its GS Gene Expression System®. The technology is designed to improve efficiency and consistency in early-stage biomanufacturing. Lonza stated that GS Ori-Go™ supports lead-clone titers exceeding 11 g/L, enables direct progression from bulk pools to clonal cell lines, and has demonstrated more than a 30% increase in titers across monoclonal antibodies, bispecific antibodies, and fusion proteins.

The company also introduced an early de-risking package that integrates development, manufacturing, and regulatory insights to support candidate selection and assess manufacturability, safety, and regulatory readiness at earlier stages of development. The package is intended to help customers establish a more predictable route toward first-in-human studies.

“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.”

Raymond Donninger, Senior Director, Commercial Development, Integrated Biologics at Lonza
CDMO News Analysed

The latest CDMO investments, partnerships, and market intelligence. Download for:

  • Full tracker of partnerships and strategic announcements.
  • Deal value of disclosed investment
  • Regional and modality trends