For biotech preclinical teams · Model to Cohort

Want to be first to clinic? Choose the right partner.

The humanized mouse model your IND is built on, and the study-ready cohorts that follow, bred in Indianapolis or Perth. One Ozgene team, the same people, from model design to IND.

2 client gene-therapy INDs cleared by the FDA in July and September 2026, both built on Ozgene humanized BAC models.
  • Humanized BAC models
  • US breeding in Indianapolis
  • Fully AAALAC accredited
FDA-cleared 2 INDs client gene therapies, Jul and Sep 2026
Humanized model >200 kb gene-targeted human BAC
Fastest 19 weeks to F1 hets, cKO and knock-in
Average 29 weeks to F1 hets, current average

Sources: ozgene.com/timelines (29-week average) · fastest 19 weeks: Ozgene project data · ozgene.com/services/humanized-mice (up to 240 kb). Timelines exclude BAC projects.

October 2026 “A first for CRISPR: powerful prime editing alters DNA directly in the human body” Nature

The race to the clinic in genetic medicine is on. Editors, oligonucleotides and gene therapies written for the human sequence need a mouse that carries it.

WhatsApp Image 2026-10-28 at 23.04.41

Where we sit on your path to IND

Your therapy targets the human gene. Your efficacy data should too.

Gene therapies, oligonucleotides and antibodies often act on human sequence or protein that a standard mouse doesn't carry. We build the human gene into the mouse, breed the colony and deliver cohorts for the studies in your IND package.

Target strategy

Humanization design with your project lead

Model build

ES cell targeting in Perth, human BAC up to 240 kb

Germline

goGermline™ to F1 heterozygotes

19–29 wk excl. BAC

Colony + cohorts

Bred, genotyped and aged in Indianapolis or Perth

Your studies

Proof of concept, efficacy and IND-enabling work

IND

Your filing, on a model you own

Ozgene · one team
Your program

Running studies in your own vivarium? Ozgene Group also provides on-site vivarium care and digital study data, so the same group can support you from GEM to IND.

Why biotech teams choose Model to Cohort

Fewer handovers between your target and your data.

Human biology

Test the drug against the human gene

Humanized gene replacements and gene-targeted human BAC models over 200 kb, built by ES cell targeting to replace the mouse gene at its own locus.

Runway

Germline and cohorts sooner

goGermline™ combines ES cell targeting with efficient germline transmission. Our fastest cKO and knock-in projects reached F1 hets in 19 weeks; the current average is 29 weeks.

Continuity

One team from design to IND

No second vendor and no colony transfer to manage. The people who design your model also breed it, in AAALAC-accredited vivariums in Indianapolis or Perth.

Records

Every animal on the record

See colonies, cages and genotypes in real time in myOzgene, powered by Geneoz VMS since 2009. Pedigree and health records are kept for every animal, and breeding is planned back from your study start date.

Evidence behind the promise

Models that have already carried programs into the clinic.

2026 · Client gene therapies

Two INDs cleared by the FDA, both built on humanized BAC models

  • July 2026: first client gene-therapy IND cleared
  • September 2026: second client gene-therapy IND cleared
  • Both programs used Ozgene humanized BAC models carrying the human gene
“I have worked with Ozgene for about 12 years and continue to be amazed at their differentiated ability to generate humanized animal models with very high probability of success and very short turnaround time.”
CSO, Boston/Cambridge biotech
  • Conditional knockouts, knock-ins and humanized gene replacements
  • Gene-targeted human BAC models over 200 kb 🔗
  • goGermline™ ES cell-derived model generation 🔗

Published timelines, side by side

Time to F1 heterozygotes (weeks)

Ozgene: 19-week shortest to 29-week average (excluding BAC). ES-cell quality at CRISPR speed. Sources: 🔗 🔗 🔗 🔗 🔗

Ready to plan?

Tell us your target and your IND timeline.

We'll come back with a model strategy, a breeding plan built back from your first study date, and the best breeding location for your program.

Model to Cohort offer

Save 20% on your custom mouse model when Ozgene breeds your colony.

You keep 100% of the IP. With Model to Cohort, Ozgene is your exclusive breeder for the agreed term.

Conditions apply. The 20% saving applies to custom mouse model generation with exclusive breeding by Ozgene.

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