Esco Aster offers Good Laboratory Practice (GLP) Toxicology — covering both GLP Tox material production and study oversight — as the endpoint of our CMC/PD Development services, or as a standalone service.
GLP Tox studies are IND-enabling studies conducted to determine whether a novel therapeutic or nutritional product is safe prior to regulatory approval for human clinical trials. They form a critical de-risking milestone in the drug and clinical food development pathway.
In the clinical nutrition and novel food space, these studies typically assess acute and/or long-term toxicity by administering high doses of a novel ingredient or product to animal models, then monitoring toxicological endpoints — including metabolite profiles, systemic exposure, and organ effects — over a defined study period.
GLP Tox studies also serve as investment milestone-enabling studies. Through Esco Aster Strategic Capital fundraising services, study outputs are aligned with investor de-risking objectives to support advancement to the next funding milestone.
New Approach Methodologies (NAMs) — including organ-on-a-chip systems, organoids, and advanced in vitro models — are increasingly being evaluated and, in select cases, accepted by regulators in IND-enabling programs.
Recent developments shaping the regulatory landscape:
Human vascularized organoids used to support an FDA IND application Human vascularized organoids were successfully used to support an FDA IND application, demonstrating growing regulatory acceptance of organoid- and organ-on-chip-based efficacy data as alternatives or supplements to traditional animal studies. Source: Fierce Biotech — First FDA IND Milestone Achieved Using Human Vascularized Organoid Efficacy Data
FDA initiative to reduce (not eliminate) animal testing requirements The FDA has announced a phased strategy to reduce reliance on certain animal testing requirements — particularly for monoclonal antibodies — by incorporating AI, organ-on-chip systems, organoids, and other NAMs. This is a case-by-case, weight-of-evidence approach, not a blanket elimination mandate. Source: FDA — FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs
FDA guidance on NAM integration into regulatory submissions FDA guidance sets out the regulatory framework for validating and incorporating NAMs — including organoids, computational models, and advanced in vitro systems — into drug development submissions, covering qualification, reproducibility, and regulatory acceptance pathways. Source: FDA — General Considerations for the Use of New Approach Methodologies in Drug Development
NAMs are also widely applied in:
Regulatory note: Animal testing requirements vary by market. Some regulatory authorities (e.g., China, for certain categories of imported cosmetics) may still require animal data depending on product classification and intended market.
In addition to traditional GLP Tox studies, Esco Aster incorporates NAMs — including our 3D Dynamic MiniTide model and other validated in vitro systems — under the 3Rs principle (Replace, Reduce, Refine) to progressively reduce reliance on animal testing.
Esco Aster can be contracted to evaluate and select the most appropriate NAM for a given program, and to assist in NAM validation in accordance with FDA guidelines or other applicable regulatory frameworks.
Esco Aster produces GLP Toxicology study materials through:
A key advantage is that GLP Tox materials are produced using the same equipment, processes, and analytical frameworks as our GMP/cGMP manufacturing operations. This alignment enables smoother technology transfer into commercial-scale manufacturing through our Manufacturing Sciences & Technology (MSAT) services.
Esco Aster develops GLP Tox study protocols and provides single-point-of-contact oversight for studies conducted at qualified third-party GLP-certified and AAALAC-accredited contract research organizations (CROs), across a range of animal models.
Rodents are the primary workhorses of preclinical toxicology.
Rats (Rattus norvegicus)
Mice (Mus musculus)
References:
Rabbits are the standard model in two specialized areas:
Embryo-Fetal Development (EFD) studies Rabbits are the required second non-rodent species for reproductive toxicology studies under ICH S5(R3) guidelines. Their placental structure is more similar to humans than that of rodents, making them a more translationally relevant model for developmental toxicity assessment.
Ophthalmic toxicology Due to the size and sensitivity of the rabbit eye, rabbits are the standard model for evaluating the ocular safety of medicines, medical devices, and specialized contact lens materials.
References:
Pigs and minipigs are highly translational models, particularly where human-like skin anatomy and physiology are critical to study validity.
Key applications:
Key advantages:
References:
Ferrets (Mustela putorius furo) are the model of choice for respiratory disease research, due to well-characterized similarities to human airway anatomy, lung cell biology, and respiratory physiology.
Primary applications:
Respiratory infectious disease — influenza and SARS-CoV-2 Ferrets are widely regarded as the most predictive animal model for influenza research. They are naturally susceptible to human seasonal and pandemic influenza A and B virus strains, and the clinical course of infection — including strain-specific symptoms — closely reflects that seen in humans. Ferrets are similarly used in SARS-CoV-2 vaccine safety and efficacy studies.
Esco Aster produces GLP Tox materials for respiratory vaccine and therapeutic programs across multiple modalities, including:
Pulmonary fibrosis The ferret model of pulmonary fibrosis demonstrates hallmark features of human idiopathic pulmonary fibrosis (IPF), including irreversible loss of pulmonary compliance, progressive opacification, and honeycomb cyst formation. Single-nucleus RNA sequencing has confirmed molecular and cellular parallels with human IPF — including AT2 cell transition toward basaloid-like cell phenotypes overlying myofibroblasts in fibrotic regions.
Other respiratory indications modeled in ferrets include:
Cell and gene therapy materials Esco Aster produces GLP Tox materials for cell and gene therapy (CGT) modalities relevant to respiratory disease, including stem cells for injection and stem cell-derived exosomes — formulated in lyophilized form for inhalation, nebulization, or nasal spray delivery.
Gastrointestinal toxicology and emetic studies Ferrets possess a well-characterized emetic response, making them the preferred species for detecting nausea- and vomiting-related toxicities that are not observable in rodent models (rodents lack a vomiting reflex). This is particularly relevant for:
Specialized GLP-compliant ferret studies are available through established partners including IITRI and Noble Life Sciences.
References:
NHPs are used when rodent and other models are insufficient — particularly for biologics, monoclonal antibodies, immunogenicity studies, and complex CNS therapeutics — due to their genetic, physiological, and immunological similarity to humans.
Cynomolgus macaque (Macaca fascicularis)
Common marmoset (Callithrix jacchus)
Rhesus macaque (Macaca mulatta)
Regulatory context — NHP reduction strategy: The FDA is actively exploring strategies to reduce routine NHP use. Current thinking includes reducing standard 6-month primate toxicology studies for mAbs to 3 months where no concerning signals are observed in 1-month studies combined with NAM data — adopting a weight-of-evidence approach. The intent is to reduce, not immediately eliminate, NHP studies for mAbs and related biologics.
References:
Esco Aster is the world's first cultivated cell-based nutrition and cell-based meat/seafood facility to receive certification from a national competent authority (Singapore Food Agency, SFA).
GLP Tox studies in the nutrition space are conducted to establish the safety of:
Standard study types conducted in this space include:
Genetic toxicity — Ames test
Genetic toxicity — Micronucleus test
Subchronic toxicity
Chronic toxicity / carcinogenicity
Developmental and reproductive toxicology (DART)
Metabolism / toxicokinetics
OECD 471
OECD 487
ICH / OECD guidelines
ICH / OECD guidelines
ICH S5(R3)
ICH S3A
GLP studies overseen by Esco Aster include:
GLP Tox studies are conducted at GLP-certified and AAALAC International-accredited third-party facilities. Esco Aster acts as a single point of contact, overseeing study design, protocol writing, material supply, and CRO coordination.
For inquiries regarding GLP Tox services, material production, or study design, please contact the Esco Aster team [email protected].