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:

Quantitative modeling: 
We build highly flexible and quantitative capacity and cost models to help you identify whether in house or outsourced manufacturing best suits the needs of your development program, optimize capacity planning, and identity high priority opportunities for cost reduction. (See more details on the Quant Modeling page here.)

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.

Technology transfer:  
We ‘hand carry’ your process to its new home to ensure success of your technology transfer, whether in-house or to a CMO.  We prepare your technology transfer package, oversee planning and execution of the process transfer, and provide person-in-plant support for the 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.

Failure Analysis: 
We use formal root cause analysis tools like Fishbone Diagrams, Failure Modes and Effect Analysis, and statistical analysis to identify root causes underpinning lot failures. Once root cause(s) are identified, we assist you in identifying, implementing, and documenting appropriate CAPAs to prevent them from re-occurring.

Manufacturing Support Science Lab
fishbone

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:

Quantitative modeling: 
We build highly flexible and quantitative capacity and cost models to help you identify whether in house or outsourced manufacturing best suits the needs of your development program, optimize capacity planning, and identity high priority opportunities for cost reduction. (See more details on the Quant Modeling page here.)

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.

Technology transfer:  
We ‘hand carry’ your process to its new home to ensure success of your technology transfer, whether in-house or to a CMO.  We prepare your technology transfer package, oversee planning and execution of the process transfer, and provide person-in-plant support for the transfer.

Science Lab

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 Diagram

Failure Analysis: 
We use formal root cause analysis tools like Fishbone Diagrams, Failure Modes and Effect Analysis, and statistical analysis to identify root causes underpinning lot failures. Once root cause(s) are identified, we assist you in identifying, implementing, and documenting appropriate CAPAs to prevent them from re-occurring.

fishbone

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