Summary
Develop and optimize manufacturing processes for eCD4-Ig, an antibody-like therapeutic for HIV, including assay validation, upstream/downstream process optimization, and formulation development, culminating in a GLP lot for IND-enabling studies.
What they want
Phase I involves validating assays for critical quality attributes (CQAs), such as sulfotyrosine content, and demonstrating that eCD4-Ig produced by new cell lines meets these CQAs. Phase II focuses on optimizing the upstream process (media/feed selection, temperature shift, fed-batch/perfusion culture), downstream process (convective chromatography including Protein A affinity, AEX, and HIC), and formulation buffers. The project will develop formulations for intravenous and high-concentration subcutaneous injection. A GLP lot of eCD4-Ig protein for IND-enabling studies will be generated, with production outsourced to a Contract Manufacturing Organization (CMO) after technology transfer.
Deliverables
- Validated assays for critical quality attributes (CQAs)
- Demonstration that eCD4-Ig protein from new cell lines meets pre-defined CQAs
- Optimized upstream process
- Optimized downstream process
- Optimized formulation buffers
- Formulation for intravenous injection
- High-concentration formulation for subcutaneous injection with acceptable viscosity
- GLP lot of eCD4-Ig protein for IND-enabling studies
Technical requirements
- Assay validation for critical quality attributes (CQAs)
- Measurement of sulfotyrosine content
- Upstream process optimization (media and feed selection, temperature shift, fed-batch versus perfusion culture)
- Downstream process based on convective chromatography (Protein A affinity, anion exchange (AEX) chromatography, hydrophobic interaction (HIC) chromatography)
- Development of formulation for intravenous injection
- Development of high-concentration formulation for subcutaneous injection with acceptable viscosity
- Production of a GLP lot of protein
- Technology transfer process for CMO outsourcing
