Why use the controlled release Microsphere Drug Delivery system?
Drugs with a short half-time often need to be administered regularly. Especially in case of injectable drugs, this causes much inconvenience to patients. They may need to visit care centers frequently or administer injections themselves. The use of a controlled release technology solves this problem.
Benefits of controlled release:
- Drug release rates can be tailored to the needs of a specific application
- Controlled release system protects drugs, especially proteins, that are otherwise rapidly destroyed by the body
- Controlled release system can increase patient compliance
We offer our proprietary technology PolyActive or develop PLA/PLGA controlled release microsphere products with you
- PLA and PLGA for the delivery of peptides and small molecules
- PolyActive for the delivery of proteins
We offer our partners 15 years of Microsphere formulation & process development experience
Formulation development experts are fully equipped to develop new microsphere formulations or optimize existing formulations. Our experts already successfully completed more than 50 microsphere projects designed for subcutaneous, intramuscular, intravitreal, and intra-articular injections. Moreover, our teams have experience with multiple drugs from small to large, from stable to very instable molecules and for different therapeutic areas such as oncology, ophthalmology and inflammation.
Process development experts are fully equipped to design and develop small to large scale, robust processes taking into account the GMP requirements. Our processes are immediately ready to be transferred to commercial operations (plug and play approach).
Analytical development experts are fully equipped to design and develop the required analytical methods.
OctoPlus fully implemented the Quality by Design methodology
What makes OctoPlus unique is the full implementation of the Quality by Design methodology (QbD) and Process Analytical Technology (PAT) that ensure the development of highest quality processes in the most efficient way. Advanced statistical tools are used such as:
- Design of Experiments (DoE) that enables our team to develop cost-effective, scalable and robust processes.
- Robustness by Design (RbD) that enables our teams to be able to develop robust, cost-effective analytical methods.
QbD is strongly advised by the regulatory agencies EMA, FDA and ICH.
Contact us if you are interested in partnering up with us!