Case Study: Accelerating the BLA Filing Timeline

Learn how BTH enabled a client to align internal stakeholders around a robust, phase-dependent, matrixed potency assay strategy and move their BLA filing forward in a timely fashion.

Situation: A client developing a neoantigen-targeted therapy sought insights on emerging best practices in potency assay development to support a successful BLA submission

Task: Elucidate historical trends in potency assay strategies for similar therapies already approved and deduce current characterization trends and most likely FDA guidance for similar therapies in development

Actions:

• Combed through FDA and EMA filings to infer patterns in regulatory requirements for potency assays of similar therapies approved to date

• Developed an umbrella framework of similar therapies in development, customized and prioritized according to attributes and characterization techniques most relevant to the client’s technology

• Integrated disparate data streams to fully articulate characterization assays for the most relevant competitors, and distilled findings into a concise narrative

• Addressed knowledge gaps by tracing the publication trail from founding scientific labs

• Validated our hypotheses using primary intel from our scientist network, published patents and trade publications

Result: Based on our insights, the client was able to align internal stakeholders around a robust, phase-dependent, matrixed potency assay strategy.  This enabled them to avoid unnecessary time-consuming regulatory setbacks and move their BLA filing forward in a timely fashion.