The decision to advance a candidate is only as sound as the data behind it. Every PK/PD profile, every efficacy readout, every biomarker result carries weight, and that weight depends entirely on the quality of the system that generated it.
That level of data quality is supported by rigorous, day-to-day practices grounded in a strong Culture of Care and the systematic application of the 3Rs (Replace, Reduce, Refine) to ensure the responsible and humane use of animals. These are precisely the principles evaluated by AAALAC International through its voluntary, peer-reviewed accreditation process—which is why IRBM has recently achieved AAALAC International accreditation.
What AAALAC Accreditation Actually Means
AAALAC International accreditation is the leading peer-reviewed, globally recognized standard for excellence in animal care, program oversight, and ethical conduct in research.
It’s entirely voluntary, and it requires a rigorous internal program review followed by a comprehensive on-site assessment conducted by an independent panel of expert evaluators.
Accreditation is awarded only when an institution’s governance structures, facilities, scientific practices, and oversight frameworks exceed regulatory baselines. Around 1,140 organizations across 52 countries hold this distinction, and now IRBM has now joined that group.
The path to accreditation validated exactly what our partners experience in practice: a preclinical organization where scientific rigor, institutional integrity, and ethical responsibility are a single integrated standard.
Why This Matters for Your Preclinical Programs
For drug hunters, the value of AAALAC accreditation translates directly into study confidence. Every in vivo dataset generated at IRBM is produced within a framework that has been independently verified for quality, reproducibility, and ethical conduct, reducing the risk of data variability that can derail candidate progression or raise questions during regulatory review.
This accreditation reinforces the robustness of IRBM’s in vivo pharmacology platform, a 1,500 m² purpose-built facility operating under the governance of an Animal Welfare Body (AWB) (Organismo per il Benessere Animale – OPBA) and now externally validated by AAALAC’s Council on Accreditation. It is independent, third-party confirmation that the preclinical data coming out of IRBM is generated to a standard that the industry’s most demanding partners can rely on.
A Fully Integrated In Vivo Platform, Validated by Design
IRBM’s in vivo pharmacology team brings industry-trained expertise across the full hit-to-candidate continuum. Whether the program involves a small molecule, peptide, monoclonal antibody or cell and gene therapy, the platform is designed to generate the mechanistic and quantitative evidence needed to make informed go/no-go decisions, efficiently and reproducibly.
Core capabilities include:
- Mechanism of Action (MoA) characterization: target engagement assays developed and validated in tissue of interest or surrogate tissue, with histology integrated from study outset
- PK/PD profiling and bioanalysis: pharmacokinetics in rodent models (wild-type and genetically modified), with access to large animal studies (dog, minipig, non-human primate) through established external partners
- Efficacy studies in oncology: subcutaneous and orthotopic xenograft models for solid and hematologic tumors, metastatic tumor models, and in vivo imaging with IVIS Spectrum for quantitative tumor tracking
- Bioavailability, organ exposure and in vivo metabolism: integrated with DMPK to provide a complete pharmacological picture of candidate behavior in the whole organism
- Responder ID and biomarker translation: bespoke PD assay development with a clear line of sight from preclinical readout to clinical translatability.
The team works iteratively and in close alignment with partners, from study design through data interpretation, ensuring that every experiment is built around the specific decision it needs to inform.
The 3Rs and a Culture of Care as Operational Principles
AAALAC accreditation is also a commitment to the principles of Replace, Reduce, and Refine, the scientific and ethical framework that governs responsible research involving animals. At IRBM, these are not compliance formalities; they are embedded in how studies are designed from day one.
The “Culture of Care” framework, research integrity, quality, and transparency, reflects the institutional values that have shaped IRBM’s preclinical operations. The accreditation process confirmed that these values are not aspirational, but structural.
Raising the Bar Across the Drug Discovery Continuum
“Raising the bar for quality and rigor in preclinical discovery is non-negotiable. It defines how studies are designed, conducted, governed, and — ultimately — the confidence our partners and we can place in every result. This accreditation is a reflection of the strength of our governance, the integrity of our science, and our unwavering commitment to delivering high-quality, reproducible data.” — Stefania Gobessi, Director In Vivo Pharmacology
AAALAC accreditation joins IRBM’s expanding portfolio of quality certifications, further consolidating its position as a partner of choice for pharmaceutical and biotech organizations that need preclinical data they can trust.