The development of highly concentrated liquid formulations (HCLFs) for subcutaneous delivery presents significant challenges in stability, manufacturability, and scalability. Traditional platform approaches often fall short, leading to costly late-stage failures. But how can we systematically improve success rates?
At Leukocare, we believe in creating clarity from complexity. In this session, we’ll explore how a data science driven approach—leveraging AI, data analytics, and predictive modeling—can de-risk formulation development and accelerate decision-making.
This session will provide strategic insights into how data-driven methodologies enhance formulation decisions, mitigate risks, and create flexible yet scalable solutions for biologic drug development.
Key takeaways include:
- Fundamental challenges in developing highly concentrated biologics—why they matter at a strategic level
- Common pitfalls in HCLF formulation that lead to program disruption
- How the application of data science and a rational excipient selection accelerates the program
- A robust formulation as a multivariate challenge and how it can successfully be addressed with the means of biostatistics
