1. What is NanoGlass™ and how does it work?

 

NanoGlass™ is SeraNovo’s proprietary technology platform that maximizes oral bioavailability by generating amorphous nanoparticles of the API. These nanoparticles create the highest possible thermodynamic driving force for absorption across intestinal membranes.

After oral administration, the formulation dissolves in the stomach, forming stable nanoparticles throughout the GI tract. As the solubilised API is absorbed, the nanoparticles dissolve to replenish the soluble fraction. This leads to significantly improved absorption, enabling more reliable preclinical data and smoother progression into clinical development.

2. Which molecules are a good fit for NanoGlass™?

 

Our platforms are versatile, but work exceptionally well for small molecules above 500 g/mol and with a degree of molecular flexibility, meaning rotatable bonds. However, we have also seen success with molecules outside this range. NanoGlass™ has proven especially powerful for challenging modalities such as protein degraders, where we routinely achieve significant bioavailability improvements.

3. How does NanoGlass™ compare to traditional approaches?

 

SeraNovo’s platforms are built to achieve the target product profile even when traditional approaches fall short. Compared to amorphous solid dispersions and lipid-based formulations, NanoGlass™ provides improved dissolution, higher drug loading, and maintained physical and chemical stability. This enables smaller dosage forms, reduced pill burden, and consistent performance, while offering a development process that is efficient and easy to scale.

4. How quickly can SeraNovo deliver a prototype formulation?

 

Our typical turnaround time is 4 to 8 weeks, including preformulation work, prototype design, and batch manufacturing for in vivo studies. This timeline enables teams to quickly generate the data needed to choose the right formulation strategy.

You can explore more about our preclinical and clinical development timelines.

5. At what stage of drug development should we engage with SeraNovo?

 

The greatest value comes from engaging with us during preclinical development. Early collaboration allows us to screen your molecule and design a formulation that meets the target product profile before significant resources are committed to downstream studies. This approach saves significant time and cost and ensures that you have a robust formulation to take into the clinic.

We also support GLP tox studies and clinical stage projects where improved oral exposure is required.

6. How does SeraNovo ensure formulations are scalable and manufacturing ready?

 

Our platforms are designed to be straightforward to scale using widely available equipment.

For our solid platforms, we use standard spray drying equipment that is present in most manufacturing facilities.

For our liquid platforms, the process involves mild heating and mixing until a uniform solution is achieved. This can be scaled up easily with off-the-shelf mixers.

Since our processes are robust, we minimize scale up risk and support our clients by coordinating with their chosen manufacturing site to ensure a smooth technology transfer.

7. What type of dosage forms can you develop?

 

Our liquid formulations can be filled in hard gel capsules, HPMC or gelatin, soft gel capsules, or administered as a liquid. Our GlassE and GlassA formulations, which are powders, can be filled into capsules or compressed into tablets.

8. Do your formulations have any side effects?

 

We use only safe, FDA-approved excipients. By combining multiple excipients, we minimize the chance of side effects, which are usually related to exceeding the threshold of a single component.

9. Can you support clinical and commercial manufacturing?

 

Our simple manufacturing processes allow almost any contract manufacturer to produce our formulations. You can choose from our preferred GMP suppliers or work with one of your choice following a seamless process transfer.

10. What is the regulatory status of your technology?

 

We use well-established excipients rather than novel ones. This means our formulations are assessed in the same way as traditional formulations from a regulatory perspective.

11. How much API is needed for a feasibility study?

 

We typically need 1-5 grams for formulation design and stability testing.

12. What deliverables come with a feasibility study?

 

We provide a comprehensive data package, including pre-formulation and formulation design results. You’ll also receive one or more prototypes from several of our platforms.

13. How do we start working with SeraNovo?

 

Contact us and we will set up an initial call to understand your molecule and development needs. After the call, we provide a short questionnaire for you to complete. Based on this information, we prepare a tailored proposal outlining our recommended strategy for developing a formulation for your molecule.