Regulatory Affairs

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.

In this example, an international tools and tech company requested a market analysis of the gene-editing and advanced therapies space as well as a facility buildout plan to manufacture a critical component for gene therapy applications.

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.

Combine BLA rejections and late-stage product delays with the rising proof of comparability burden as therapies approach a regulatory hurdle, and an expert comparability review becomes a near-necessity.

Dark Horse offers varying levels of analytical support, ranging from high-level strategic oversight to detailed tactical operational support. In this case, the client required a broad scope of guidance while preparing to file for licensure.

When a company develops a product for use in a cell and gene therapy process, one of the steps is to get that product (complete with any consumables for use) approved. This client asked for assistance in the associated regulatory process.

Clinical development of CGT products is increasingly an international endeavor, requiring an integrated global regulatory strategy.

This study highlights a custom piece of manufacturing equipment for a cell therapy client. In addition to engineering oversight, DHC also provided regulatory and PM support.

DHC’s support for this client's gene-modified cell therapy platform demonstrated comparability of the improved manufacturing process (thus streamlining associated filings with global regulators).