Phase 1 - Consultation with an Expert
Definition of the project’s aims and challenges
Integrated Preclinical In Vivo Studies (non GLP)
As part of the regulatory pathway for new drug and vaccine candidates, BioGenes offers comprehensive preclinical in vivo studies under non-GLP conditions. These studies are essential in early-phase development and provide foundational data on efficacy, safety, and biological responses. We conduct the following preclinical in vivo study types:
Each study is carefully designed to align with the specific characteristics of your compound. We utilize mouse models with either intact or genetically modified immune systems, ensuring physiological relevance and translational value. All studies are conducted under approved ethical guidelines and in close coordination with our clients to ensure scientific rigor and regulatory compliance.
Efficacy studies
Our efficacy studies are designed to assess the immunogenicity and protective potential of vaccines and biologic candidates in vivo. These studies evaluate key parameters such as:
- Antibody titer and neutralization capacity
Cellular immune responses (e.g., T-cell activation, cytokine production)
Pharmacokinetics & Pharmacodynamics (PK/PD)
In addition, we offer exploratory pharmacokinetic/pharmacodynamic (PK/PD) studies to understand how your compound behaves in vivo. These studies provide critical insights into:
- Absorption, distribution, metabolism, and excretion (ADME)
- Interaction with biological systems, especially immune-related dynamics
- Support for early dose selection, formulation strategies, and compound prioritization
Depending on the research objective and compound class (e.g., small molecules, biologics), we employ immunocompetent or immunodeficient mouse models.
Please note: These studies are all exploratory and not designed to demonstrate therapeutic efficacy or predict clinical outcomes.
Toxicity and Dose-Finding Studies
To support early-stage safety profiling, BioGenes also offers exploratory non-GLP toxicity studies in mice. These studies help to define appropriate dosing strategies and identify potential safety risks before entering regulatory toxicology.
In a structured two-step approach:
1. Single-dose studies are conducted across a range of concentrations to detect systemic or organ-specific toxicities.
- Monitoring clinical symptoms, weight, and behavior
- Assessment of organ toxicity and histopathology
2. Based on these findings, a target dose is selected for repeated administration. A follow-up assessment includes detailed analysis of affected organs, tissues, and cells to assess cumulative effects and overall tolerability.
These non-GLP toxicology studies serve as a basis for early safety profiling and dose range finding, providing an informed go/no-go decision in early development.
Note: These studies do not aim to demonstrate disease modification or therapeutic efficacy.
Challenge Studies
Our in vivo vaccine challenge models are designed to evaluate the protective efficacy of new vaccine candidates under realistic infectious conditions. These non-GLP studies play a crucial role in early phase vaccine development, especially for infectious disease targets. The challenge studies address two key questions:
- Does the vaccine induce a measurable immune response?
- Does it protect against the target pathogen?
Study Design
Phase 2 - Immunogenicity Assessment
Vaccinated mice are analyzed for antibody titers in serum to evaluate the strength and the specificity of the immune response.
Phase 3 - Pathogen Challenge
After immunization, animals are challenged with the relevant live or attenuated pathogen (based on vaccine target). Following a defined incubation period, based on client requirements or scientific literature, animals are euthanized, and organs, tissues, and blood are collected.
The endpoint analysis is performed by the client.
These studies enable an exploratory assessment of protective efficacy, particularly for infectious disease vaccine development, using ethically and scientifically validated animal models.
Note: These studies are not designed to establish causal therapeutic relationships.
Ethics & Responsibility
At BioGenes, all in vivo studies are conducted in strict accordance with EU Directive 2010/63/EU and relevant national animal welfare laws. All experimental protocols are reviewed and approved by appropriate regulatory authorities.
We are fully committed to the 3R principles – Replace, Reduce, Refine – and continuously strive to minimize animal burden through optimized study designs, refined procedures, and expert veterinary care, without compromising scientific integrity. Transparency, responsibility, and collaboration are fundamental to how we operate.
Our studies follow internationally accepted scientific and regulatory standards, including:
- The ICH S6(R1) Guideline for preclinical safety evaluation of biotechnology-derived pharmaceuticals
- The ICH M3(R2) Guideline on non-clinical safety studies to support clinical trials
- The EU Regulation 536/2014, which outlines requirements for clinical trial documentation including preclinical data
- The German Medicines Act (AMG), §22 Abs. 1 und 2, which regulates national pharmaceutical approvals and preclinical study requirements in Germany
Our Scientific and Technical Capabilities
Each study can be flexibly designed and customized to align your specific research objectives and development strategy.
Together with you, we define critical experimental parameters to ensure scientific relevance and translational value, including:
- Selection of mouse models with defined immune status (e.g. immunodeficient, humanized)
- Choice of strain or genetic background
- Study Duration and observation period
- Dosing schedule: number, frequency and timing of administrations
- Formulation strategy, including the use of adjuvants if applicable
- Frequency and timing of sample collection
We offer a range of established mouse strains (e.g., BALB/cJRj, C57BL/6NRj, RjOrl:SWISS) suitable for immunology and vaccine research, with strong translational relevance due to their broad antibody repertoires. For advanced immunological studies, we provide humanized models (e.g., BRGS A2DR2-HIS) and immunodeficient strains (e.g., BALB/c Nude, B6Rag2) to investigate human-like immune responses or drug effects in immunocompromised settings.
All models can be adapted or expanded based on project needs. As each study is submitted individually for regulatory approval, client-specific mouse strains and study parameters (e.g. dose, administration schedules, and sampling timelines) can be fully customized.
Note on Pre-clinical Animal Studies:
Please note that each pre-clinical animal study requires an individual application and approval by the competent authority (e.g. LAGeSo) prior to initiation. This may affect the overall project timeline.
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