GLP Tox Formulations
GLP Tox Formulations
GLP tox formulations have different end points and thus require a different approach to bioavailability enhancing clinical formulations. We support preclinical safety studies with oral formulations purpose designed for toxicology use. Our GLP tox formulations are built for high systemic exposure and repeat-dose stability, offering an ideal foundation for first-in-human readiness.
What We Offer
Our toxicology programs provide access to SeraNovo’s proprietary technologies, paired with our analytical capabilities and formulation expertise. We focus on:
High-Load Formulations with Approved Excipients
High drug-loading limits excipient toxicity effects, enabling robust toxicology analysis.
The exclusive use of FDA-approved excipients to ensure safety and consistency during repeat dosing
Enhanced stability for single preparation
Formulations are designed to remain stable for multi-day dosing from a single preparation.
Formulations are gavage-friendly, with included preparation protocols to support accurate and repeatable dosing
Simple onsite preparation
Our formulations are simple to prepare using standard equipment.
Each program includes a GLP tox formulation report detailing composition and preparation steps, ensuring smooth transfer to GLP-compliant study sites
Timeline and Deliverables
Total study duration: 9 weeks, with the final formulations delivered tailored to your study purpose.
Week 0
Agreed Project Scope And Objectives
Week 2
Pre-formulation data package
Week 2-4
Prototype development data package
Week 4-8
Stability study report
Week 9
in-vivo study batches manufactured
Understanding your needs
- Target product profile tailored to your molecule and project goals
- NanoGlass™ platform evaluation
Pre-formulation
- Pre-formulation experiments to understand the physicochemical profile of your API
- Pre-formulation data package
GLP Tox Formulation Design
- Formulation design guided by pre-formulation results
- Formulation development data package
Stability study
- Chemical and physical stability testing of lead formulations
- Stability study report
Batch Manufacturing
- Manufacture of batches for in-vivo use, including full batch documentation, gavage suitable check, and a dosing or pre-dispersion protocol
- In-vivo study batches manufactured and shipped to location
Week 0
Agreed Project Scope And Objectives
Understanding your needs
- Target product profile tailored to your molecule and project goals
- Nanoglass™ platform evaluation
Week 2
Pre-formulation data package
Pre-formulation
- Pre-formulation experiments to understand the physicochemical profile of your API
- Pre-formulation data package
Week 2-4
Prototype development data package
GLP Tox Formulation Design
- Formulation design guided by pre-formulation results
- Formulation development data package
Week 4-8
Stability study report
Stability study
- Chemical and physical stability testing of lead formulations
- Stability study report
Week 9
in-vivo study batches manufactured
Batch Manufacturing
- Manufacture of batches for in-vivo use, including full batch documentation, gavage suitable check, and a dosing or pre-dispersion protocol
- In-vivo study batches manufactured and shipped to location
Get in touch to find out how our NanoGlass™ technology can help your drugs reach their full therapeutic potential
