Pre-Clinical and Clinical Formulations
We work with pharmaceutical and biotech companies to develop high-performance oral formulations for pre-clinical and clinical development. Using our proprietary platform technologies, we develop scalable, bioavailability-enhancing formulations tailored to your molecule, with manufacturability in mind from day one.
What We Offer
Our formulation programs provide access to SeraNovo’s proprietary platforms, supported by our in-house scientific expertise. We focus on:
Access To Platform Technologies
Our proprietary formulation platforms are designed to overcome poor solubility and permeability. They enable improved bioavailability, reduced pill burden, and scalable manufacturing.
Informed Screening and Selection
Every formulation is developed with scalability and downstream processing in mind. We consider dose feasibility, excipient compatibility, and tech transfer readiness from the start.
Designed For Clinical Progression
Our formulations are designed to transition seamlessly from preclinical to clinical stages. We prioritize regulatory-compliant excipients, reproducible manufacturing, and scalable processes that support IND filing and beyond
Timeline and Deliverables
Total feasibility study duration: 8-12 weeks, with the final formulations tailored to your study purpose
Week 0
Agreed Project Scope And Objectives
Week 2
Pre-formulation data package
Week 6-8
Prototype development data package
Week 6/8-12
Stability study report
Week 12
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
Prototype development
- Formulation design and development using 3–4 platforms, 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 small-scale batches for in vivo evaluation
- In-vivo study batches manufactured and shipped to study site
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 6-8
Prototype development data package
Prototype development
- Formulation design and development using 3–4 platforms, guided by pre-formulation results
- Formulation development data package
Week 6/8-12
Stability study report
Stability study
- Chemical and physical stability testing of lead formulations
- Stability study report
Week 12
in-vivo study batches manufactured
Batch Manufacturing
- Manufacture of small-scale batches for in vivo evaluation
- In-vivo study batches manufactured and shipped to study site
Get in touch to find out how our NanoGlass™ technology can help your drugs reach their full therapeutic potential
