Breaking News

Lonza Enhances Biologics Preclinical Development Offering

DNA‑to‑IND offering leveraging GS Ori‑Go designed to deliver tox material in approximately two months, and IND readiness in as little as six months.

Author Image

By: Kristin Brooks

Managing Editor, Contract Pharma

Lonza

Lonza has enhanced its biologics preclinical development offering designed to help customers make more confident early‑stage decisions and to accelerate timelines and reduce development risk.

The offering integrates development, manufacturing, and regulatory insight from the outset to help deliver faster, more predictable progress without compromising quality. The enhanced offering leverages its new GS Ori‑Go vector technology designed to help improve productivity and consistency in early‑stage biomanufacturing and builds on the GS Gene Expression System, which has supported over 100 commercial products. The DNA-to-IND program aims to enable early-stage pharma and biotech companies to rapidly progress from early discovery to clinical readiness.

Early de‑risking 

Lonza’s new early de-risking package aims to deliver data-driven, integrated insights across development, manufacturing, and regulatory processes to help provide a comprehensive picture of safety, manufacturability, and regulatory readiness early on. This enables evidence-based candidate selection and establishes a more predictable path towards first-in-human studies.

Accelerated DNA‑to‑IND timelines 

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, according to the company, leveraging streamlined process development and proven platform technologies.

GS Ori‑Go

As part of this enhanced offering, Lonza launched GS Ori-Go, a next-gen 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 proteins, according to the company.  

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters