MANUFACTURING SUPPORT

Identifying and implementing the optimal cGMP manufacturing strategy is critical to the success of any cell and gene therapy program, but is often cited by developers as one of their greatest challenges. Our experienced team assists you in all aspects of this journey, including:

Build vs. Buy analytics:
We build quantitative capacity and cost models to help you identify whether in house or outsourced manufacturing best suits the needs of your development program.

CMO selection:
Using our proprietary, quantitative RFP process, and our deep knowledge of the cell and gene therapy CMO landscape, we author your RFP, solicit responses from qualified contract manufacturing organizations (CMOs), audit lead candidates, and evaluate responses to select the optimal partner for the specific needs of your process and organization.

CMO oversight:
We oversee your technology transfer to your selected CMO, and provide person-in-plant (PIP) support for effective CMO management. We work with you every step of the way to ensure a successful tech transfer.

Facility design:
We assist you in designing a facility that is optimized for the needs of your specific process and organization. Our experienced scientists and engineers develop conceptual designs tailored to your process and workflow. Our architect translates those designs into comprehensive buildout plans.  Our project management professionals solicit competitive quotes and oversee project timelines.

Manufacturing Support Science Lab

Identifying and implementing the optimal cGMP manufacturing strategy is critical to the success of any cell and gene therapy program, but is often cited by developers as one of their greatest challenges. Our experienced team assists you in all aspects of this journey, including:

Build vs. Buy analytics:
We build quantitative capacity and cost models to help you identify whether in house or outsourced manufacturing best suits the needs of your development program.

CMO selection:
Using our proprietary, quantitative Request for Proposal (RFP) process, and our deep knowledge of the cell and gene therapy Contract Manufacturing Organization (CMO) landscape, we author your RFP, solicit responses from qualified CMOs, audit lead candidates, and evaluate responses to select the optimal partner for the specific needs of your process and organization.

Science Lab

CMO oversight:
We oversee your technology transfer to your selected CMO, and provide person-in-plant (PIP) support for effective CMO management. We work with you every step of the way to ensure a successful tech transfer.Manufacturing Support Diagram

Facility design:
We assist you in designing a facility that is optimized for the needs of your specific process and organization. Our experienced scientists and engineers develop conceptual designs tailored to your process and workflow. Our architect translates those designs into comprehensive buildout plans.  Our project management professionals solicit competitive quotes and oversee project timelines.