Frequently Asked Questions

How do you manage genetic drift in complex CRISPR-edited colonies?

A: We employ a multi-faceted strategy including routine single nucleotide polymorphism (SNP) panel analysis to monitor genetic background, scheduled re-derivation from cryopreserved stocks to reset the genetic state, and robust cryopreservation of founder lines to secure the original validated model.

What is the typical timeline for expanding a founder line to a GxP study cohort?

A: The timeline is model-dependent, influenced by breeding efficiency and the desired cohort size. A typical expansion from validated founders to a GxP-ready cohort is a multi-month process encompassing timed breeding, genotyping, and comprehensive health screening to ensure study readiness.

How does Franklin Biolabs ensure high standards of animal welfare?

A: Our operations adhere to the highest ethical and scientific standards. We operate under the strict oversight of our Institutional Animal Care and Use Committee (IACUC) and are guided by the principles of AAALAC International to ensure exemplary animal welfare.

Can you support breeding schemes for models with complex inheritance or reduced viability?

A: Yes. Our vivarium specialists design and execute customized breeding strategies to manage complex genetics or models exhibiting challenging phenotypes. This includes the use of surrogate programs, intensive neonatal monitoring, and specialized husbandry protocols to maximize colony productivity and welfare.

Managing genetically engineered rodent models, particularly novel CRISPR-derived lines, requires specialized infrastructure and deep expertise to ensure the genetic integrity and phenotypic consistency demanded by IND-enabling studies. Franklin Biolabs provides comprehensive colony management services within our >100,000 sq ft GxP-compliant facility, offering programs access to advanced breeding strategies and rigorous quality control. Our approach supports complex therapeutic programs, from RNA therapeutics to gene therapies, by delivering well-characterized and study-ready cohorts.

A Framework for GxP-Compliant Colony Management

Our approach integrates multiple quality control layers to produce and maintain research colonies suitable for GxP studies. This framework is built on four key pillars:
1. Genetic Quality Control: We implement speed congenics to rapidly establish models on desired genetic backgrounds and perform routine SNP analysis to monitor for genetic drift. All CRISPR edits are sequence-verified to confirm fidelity.
2. Health & Biosecurity: Colonies are maintained in strict barrier facilities with robust sentinel programs for pathogen screening. These biosecurity measures prevent infections that could alter physiological responses and confound study results.
3. Cryopreservation & Archiving: We secure every valuable line through sperm and embryo cryopreservation. This practice provides a secure backup and enables re-derivation to reset genetic drift, protecting long-term program assets.
4. Animal Welfare & the 3Rs: Our commitment to the 3Rs (Replacement, Reduction, and Refinement) is a core component of our scientific and ethical strategy, ensuring animal welfare and improving data quality.

This rigorous management directly supports a predictable 18-24 month IND timeline by reducing study variability and minimizing the need for repeat experiments. Since 2019, programs managed by our scientific leadership have achieved a 100% IND success rate; the Franklin Biolabs brand itself launched in 2024.