Case Study Library
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 as many as six. 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.
The first step in this process may well sound like the final step, demonstrating 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.
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.