API - Innocore Pharma

Proteins and especially (monoclonal) antibodies, play an increasingly important role in the current pharmaceutical landscape. Within protein and antibody delivery it is crucial to deliver them structurally intact at the desired site and at therapeutically effective levels. For this reason, local or site-specific delivery is often a prerequisite to achieve optimal therapeutic benefit. Aqueous buffered protein formulations are typical, however these solutions may be unstable and not suitable for further processing into advanced dosage forms. To formulate proteins and antibodies, we use our proprietary SynBiosys® platform. By leveraging this platform, we demonstrate sustained and controlled release for periods ranging from weeks to over six months. During release, we are able to maintain the structural integrity and activity due to the unique properties of our polymer platform. Instead of relying on aqueous formulations, we use stable dry powder forms of therapeutic proteins through lyophilization and spray-drying of proteins in amorphous matrices.

Several formulation possibilities, including microspheres, coatings and implants
No accumulation of acidic degradation products, allowing proteins to remain structurally intact
High encapsulation efficiency (on average higher than 80%)
High loadings compared to other formulations (approximately 15-20%)
Sustained and controlled release by diffusion of the protein or antibody from the polymer matrix. Diffusion is tuned by varying the SynBiosys building blocks ratio resulting in limited or no burst
Hydrophilic PEG provides improved protein or antibody interaction and prevents direct polymer interaction
Protection from high shear forces during processing
Protection from increased temperature (during processing and storage)
Protein and antibody formulations are protected from environmental influences by the polymer matrix
Optimal control over the physicochemical and degradation characteristics

Read more about our polymer platform SynBiosys® here