What is AAALAC International?

A: The Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International is a private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs. It is the recognized global standard for animal care and use programs.

Is AAALAC accreditation required by regulatory bodies like the FDA?

A: While not explicitly mandated by the FDA, AAALAC accreditation is considered the gold standard and is strongly favored. It demonstrates a commitment to quality and ethical standards that goes beyond basic regulatory requirements, which strengthens the integrity of the data submitted in an IND package.

How does accreditation reduce study variability?

A: Accreditation enforces rigorous standardization of housing, environment, diet, and handling procedures. This minimizes non-experimental variables that can introduce noise into biological data, leading to more precise, reproducible, and statistically powerful results.

What is the difference between being USDA-compliant and AAALAC-accredited?

A: USDA compliance, under the Animal Welfare Act, sets the minimum legal standards for care. AAALAC accreditation is a voluntary, higher-level commitment that signifies a program has achieved excellence and goes beyond the minimum requirements, focusing on comprehensive quality and continuous improvement.

AAALAC International accreditation is a direct indicator of a CRO’s commitment to producing high-integrity, reproducible in vivo data. For sponsors developing advanced therapies, selecting an accredited facility mitigates program risk by minimizing non-protocol-induced biological variability that can confound study results and compromise regulatory submissions. This framework of excellence directly supports the interpretation of complex dose-dependent effects and ensures the long-term data stability required for a successful IND filing.

The integrity of nonclinical data hinges on the quality and consistency of the in vivo models used. AAALAC accreditation provides an internationally recognized framework that enforces rigorous standards for every aspect of animal care, from environmental enrichment and housing to veterinary oversight and staff training. This systematic approach directly translates to higher quality data by reducing confounding variables.

For a therapeutic program on an 18-24 month IND timeline, unexpected variability can lead to costly delays and repeat studies. An accredited program ensures that observed biological responses are a direct result of the therapeutic intervention, not subtle environmental stressors or inconsistent husbandry practices. This level of control is integral to building a data package that can withstand intense regulatory scrutiny.

Advanced therapy programs require both a demonstration of efficacy and a complete characterization of the biological response, including potential adverse effects. As seen in early-stage gene transfer studies for metabolic deficiencies, dose-dependent effects and immune responses are key signals that must be accurately captured (PMID: 11779420). An AAALAC-accredited environment minimizes background noise, allowing for a clearer interpretation of these dose-response relationships.

This principle is equally relevant for long-term efficacy and safety assessments. For instance, demonstrating a stable, long-term reduction of a target like PCSK9 following in vivo genome editing requires data collected over many months (PMID: 33609733). The consistency guaranteed by an accredited program is what makes such longitudinal data reliable and defensible, providing confidence in the durability of the therapeutic effect.

Franklin Biolabs’ program is built upon the “Three Rs” (Replacement, Reduction, and Refinement) and is fully accredited by AAALAC International and registered with the USDA. This dual commitment ensures that all studies are conducted under the highest ethical and scientific standards. This commitment to robust, standardized systems directly supports successful in vivo study execution.

Within our >100,000 sq ft facility, every in vivo study is executed within this accredited framework. This commitment has been a key factor in our ability to support our partners in achieving a 100% IND success rate since 2019. (The Franklin Biolabs brand launched in 2024.) Partnering with an AAALAC-accredited CRO enhances the scientific validity and regulatory defensibility of your preclinical program, built upon a framework of the highest ethical standards.

• Standardized Operating Procedures (SOPs): Rigorous, harmonized protocols for all animal care and technical procedures.

• Comprehensive Staff Training: Continuous education and proficiency verification for all vivarium and technical staff.

• Proactive Veterinary Care: A dedicated veterinary team focused on preventative health and immediate response.

• Environmental Controls: Precisely monitored and controlled environmental parameters (e.g., temperature, humidity, light cycles) to ensure consistency.