University of Toronto Bonfire #UOT202617495

GMP-like Manufacturing Services for SBT02 Recombinant Protein for IND-Enabling Studies

This opportunity from the University of Toronto seeks specialized manufacturing services for a GMP-like (GLP-grade) SBT02 recombinant protein to support IND-enabling nonclinical studies in neurodegenerative disease research. - Government Buyer: - University of Toronto - OEMs and Vendors: - SBT02 recombinant protein is the only product specifically mentioned; no OEMs or vendors are named - Products/Services Requested: - Manufacturing services for SBT02 recombinant protein - Includes cell banking and/or cell bank qualification - Process development and scale-up - Analytical method development and release testing - GMP-like manufacturing - Preparation of supporting documentation - Unique/Notable Requirements: - Production must be at GMP-like (GLP-grade) quality suitable for IND-enabling studies - Focus on neurodegenerative disease research - Submission requirements include proposal forms, conflict of interest declarations, technical and financial submissions, and reference forms

Description

This solicitation is for manufacturing services to produce GMP-like (GLP-grade) SBT02 recombinant protein to support IND-enabling nonclinical studies focused on neurodegenerative disease research. The scope includes cell banking and/or cell bank qualification, process development and scale-up, analytical method development and release testing, GMP-like manufacturing, and preparation of supporting documentation. The project requires submission of various documents including proposal forms, conflict of interest declarations, technical and financial submission requirements, and reference forms.

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