Samples of Case Studies
Here, we’ve collected case studies across our range of (ultimately) a dozen service types to provide examples of what one might experience as a client working with us in each areas. It’s common for a case study to include an overlap of two service types, sometimes more. All case studies examples are taken from real-world client experiences but are blinded to protect confidentiality.
Watch this space for new case studies, added biweekly in reverse chronological order, with the most recent addition at the top.
This client requested design and outsourcing of preclinical efficacy and safety studies to demonstrate comparability of a changing clinical stage manufacturing process.
Diligence in C> requires not only the necessary research,
but also an integrated in-depth analysis and interpretation of the findings based on a deep understanding of the technical field.
This client requested assistance in codifying their manufacturing process in preparation for an international technology transfer and global regulatory filings.
Assistance with the design/use of studies demonstrating biological relevance of a lead candidate in vitro potency assay demonstrates a common overlap b/t analytical and preclinical service areas.
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.
Financing/diligence support for this VC client involved a rapid evaluation of CMC Phase 3 readiness for a cell therapy asset (complete with an element of Quality Systems).
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).
This client required CMO selection assistance (a key element of manufacturing support) to provide a clear path for their preclinical-stage gene therapy program.
