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Immunogenicity Sub-team Announcement: PEGS Boston User Group

‘SC Administration and Immunogenicity Risk; Current Understanding and Future Considerations for Novel Modalities’ In order to focus on the most important considerations for SC product development, developers must have a data-driven understanding of contributing factors to SC and IV immunogenicity (features of the immune response, product attributes, etc.) and correlation to safety/adverse events following SC route of delivery. The Immunogenicity sub-team of the Subcutaneous (SC) Drug Develop...
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Notification of Virtual Workshop ‘Roadmapping the Clinical and Regulatory Paths of SC Products and Technologies’

The Clinical Development & Regulatory Strategy (CDRS) sub-team of the Subcutaneous (SC) Drug Development and Delivery Consortium is excited to announce their upcoming virtual workshop ‘Roadmapping the Clinical and Regulatory Paths of SC Products and Technologies’, sponsored through AAPS (https://subcutaneousconsortium.org/cdrs-workshop-announcement/) In this workshop, taking place February 23rd, we will bring industry professionals, academics, and regulatory experts together to share kno...
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Subcutaneous Delivery of High-Dose/Volume Biologics: Current Status and Prospect for Future Advancements

Manuscript Objectives: Review the challenges and opportunities for SC delivery of high dose/volume biologics Consider…...
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Predicting bioavailability of monoclonal antibodies after subcutaneous administration: Open innovation challenge

Manuscript Objectives: Explore a potential biopharmaceutics classification system that could guide the development of a…...
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Accelerating the Development of Novel Technologies and Tools for the SC Delivery of Biotherapeutics

Key Objectives: Provide overview of the mission and objectives of SC Consortium to advance the…...
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