Lonza expands biologics development offering with faster DNA-to-IND pathway

Lonza, a global contract development and manufacturing organization (CDMO) headquartered in Basel, Switzerland, has announced updates to its preclinical biologics development offering designed to help customers accelerate timelines and reduce risk on the path from early discovery to clinical trial application.

The offering integrates development, manufacturing, and regulatory input from the outset, according to the announcement. For monoclonal antibody programs, the approach targets IND readiness in as little as six months, with toxicology-grade drug substance available in approximately two months, the company said.

As part of the update, Lonza launched GS Ori-Go, a next-generation vector platform for its GS Expression System, which the company said has supported more than 100 commercial products. The platform supports protein production titers above 11 g/L and allows direct progression from early-stage cell pools to individual clonal cell lines, removing intermediate selection steps that can add time and complexity to development, according to the CDMO.

Lonza said the platform demonstrates more than a 30% increase in titers across multiple therapeutic formats including monoclonal antibodies, bispecific antibodies, and fusion proteins. The offering also includes a de-risking package that provides integrated data across development, manufacturing, and regulatory readiness to help companies evaluate whether a lead drug candidate is viable and scalable before committing to full development.

Raymond Donninger, senior director of commercial development for integrated biologics at Lonza, said in a statement the approach is intended to help customers make early-stage decisions sooner and with greater clarity, progressing biologics programs to the clinic with greater speed and confidence.

The announcement follows other recent platform introductions at Lonza. Last month, the company partnered with Oxford Nanopore Technologies to launch a direct RNA sequencing solution for mRNA quality control testing, designed to assess multiple critical quality attributes in a single GMP workflow and reduce testing time from weeks to less than one day.