Case Studies

Here, we’ve collected case studies across our range of a dozen service types to provide examples of what one might experience as a client working with us in each area. 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. The most recently-released case study appears at the top.

 

A pure-play gene tx 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 C&GT (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.

 

Combine 2020’s string of 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. Read about the steps taken to prepare this biotech for their upcoming cell therapy BLA filing. 


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. 

 

Successful entry into a space such as C&GT requires thorough market research by a firm versed in the technical complexities of the field. This case study demonstrates a complete Market Research work-up.

 

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


Due to our extensive expertise in C&GT, Dark Horse is uniquely positioned to identify attractive investment opportunities. Here, we performed a detailed landscape scan for a client interested in investing in the space.


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 exemplifies proactive project management of cross-functional program details; specifically, those that occur at the interface of CMC and clinical operations.


Business opportunities in C&GT require gathering highly specific/technical information about current and future market expectations to both pressure-test and guide decision-making.


Clinical development of cell and gene therapy products is increasingly an international endeavor, requiring an integrated global regulatory strategy.


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 design and outsourcing of preclinical efficacy and safety studies to demonstrate comparability of a changing clinical stage manufacturing process.


Diligence in C&GT 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.

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