Identifying and implementing the optimal cGMP manufacturing strategy is critical to the success of any CGT program, but is often cited by developers as one of their greatest challenges. Our experienced team assists you in all aspects of this journey.
We build highly flexible quantitative capacity and cost models to help you optimize capacity planning, identify opportunities for cost reduction, and identify whether in-house or outsourced manufacturing best suits the needs of your development program.
Using our proprietary, quantitative RFP process and our deep knowledge of the CGT CDMO landscape, we work with you to establish a bespoke URS, author your RFP, solicit responses from qualified contract manufacturing organizations (CMOs/CDMOs), audit lead candidates, and evaluate responses to select the optimal partner for the specific needs of your process and organization.
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.
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.
For clients currently without internal leadership focused on this core capability, senior DHC experts can provide interim expertise and leadership with the goal of enabling the clients to identify, hire, and onboard internal candidates in a timely manner.