Manufacturing Operations

DHC was engaged to provide strategic guidance in building a “hotel”-style manufacturing facility, which requires the ability to provide flexible GMP clean room suites for direct use by a wide range of early-stage manufacturing clients.

An academic organization was planning to retrofit a U.S.-based facility to meet their needs for both HCT/P manufacturing as well as multi-product early-stage cell therapies.

When a client's project's timeline was in jeopardy due to a lack of communication between the vendor and the client, DHC’s project management services were added to support overall project governance.

This example demonstrates that it is rarely too late to ask for a expert overview. A thorough review of the facility design documents yielded many design improvements that were possible even at this late stage, which provided significant operational improvements to benefit the facility long-term.

A pure-play gene therapy client whose product was just being spun out of academia brought DHC in early to provide long-term guidance, conceptualizing and building a dev process that would stand up to the challenges of future trial phases and into commercial production.

This case study follows the experience of a client who is new to CGT (though otherwise practiced in late stage processes) and requires CRL remediation to prepare for BLA resubmission.

Take a look at how sometimes a quantitative review can yield the excellent news that your program is in better shape than you realized.

Nonsensical, counterintuitive, or otherwise "off" data is likely to signal a problem. A team with remediation experience, like Dark Horse's, can perform a failure analysis to identify and remediate the source(s) of the issue. 

Precision is key, especially in a(n international) tech transfer. DHC provided Person in Plant support in managing dose preparation training of clinical sites for this client's flagship product.

This case study considers DHC’s proprietary quantitative modeling software, and how its adaptive approach provides clients with highly-customized probability-weighted forecasting.

This client requested assistance in codifying their manufacturing process in preparation for an international technology transfer and global regulatory filings.

This client required CDMO selection assistance (a key element of manufacturing support) to provide a clear path for their non/preclinical stage gene therapy program.