Development and Manufacturing of Long-acting Injectable Microparticles for Sustained Release of Biologics
Monday, July 26th - 12pm (Noon) EST
The global protein therapeutics market is expected to grow by more than $82 billion until 2024 representing a CAGR of 7%. The growing importance of biologics in the treatment of chronic and site-specific diseases is driving a strong demand for patient-friendly long-acting injectable (LAI) drug delivery technologies for this class of therapeutics.
Poly(lactide-co-glycolide) (PLGA) polymer-based LAI formulations have been used clinically since 1989. However, due to incompatibilities of biologics with PLGA polymers and despite 30 years of research and development on alternative biodegradable polymer systems, no biodegradable polymer-based LAI for proteins and monoclonal antibodies have made it to the market yet. SynBiosys® biodegradable hydrophilic poly(ether ester) urethane multi-block copolymers were developed to provide long term sustained release of structurally intact and biologically active proteins and are now successfully used in several LAI development programs.
This presentation will cover the development of LAI microparticles for biologics from start to finish, and include early-stage product design considerations, process scale-up, regulatory aspects in relation to nonclinical safety studies of polymeric excipients and GMP manufacturing of clinical supplies.
Poly(lactide-co-glycolide) (PLGA) polymer-based LAI formulations have been used clinically since 1989. However, due to incompatibilities of biologics with PLGA polymers and despite 30 years of research and development on alternative biodegradable polymer systems, no biodegradable polymer-based LAI for proteins and monoclonal antibodies have made it to the market yet. SynBiosys® biodegradable hydrophilic poly(ether ester) urethane multi-block copolymers were developed to provide long term sustained release of structurally intact and biologically active proteins and are now successfully used in several LAI development programs.
This presentation will cover the development of LAI microparticles for biologics from start to finish, and include early-stage product design considerations, process scale-up, regulatory aspects in relation to nonclinical safety studies of polymeric excipients and GMP manufacturing of clinical supplies.
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