Success Story:NovoSphere™Transforming Antibody Therapies through Extended Release
Challenge
A biotechnology company developing monoclonal antibody (mAb) therapies faced limitations in dosing frequency and patient adherence. Their current formulation required weekly injections, due to rapid clearance and poor stability. This dosing burden limited commercial potential, raised healthcare costs, and created patient compliance concerns. They needed a new delivery approach that would allow for extended release, stability at ambient temperatures, and broader access to markets with limited cold chain support.
Solution
The company partnered with Likarda to explore its NovoSphere™ platform—an advanced encapsulation solution using Likarda’s proprietary Core-Shell Spherification® (CSS®) technology. The monoclonal antibody was encapsulated in microspheres designed for long-acting delivery. The approach included crystalizing the mAb prior to encapsulation to further extend release, and lyophilizing the product to create a shelf-stable dry format that could be easily rehydrated before use.
Testing Highlights
- Compared to the rapid burst and clearance of the standard formulation, the NovoSphere™-encapsulated antibody exhibited a controlled, gradual release over 21 days.
- Microscopic imaging showed stable bead morphology after lyophilization and full recovery upon rehydration—confirming product compatibility with dry storage logistics.
- This approach was successfully replicated with other biologics, including adalimumab (Humira®), confirming the platform's versatility across different antibody formats.
Outcome
The NovoSphere™ formulation enabled a once-monthly injection strategy, significantly reducing the treatment burden and improving patient experience. The powder format increased stability and shelf life, eliminating the need for deep cold storage. Additionally, the new formulation provided IP differentiation and opened up new markets where refrigerated storage is a challenge.
