Formulation Development

Before starting the main phases of formulation development, critical assays are carried out to gain a thorough understanding of the product's properties.

Using design of experiments (DoE), we explore various parameters, including buffer composition, additives, and pH values. This involves testing multiple concentrations of FDA-approved buffer components and additives, along with different pH levels. Detailed evaluations will be performed on at least two buffer systems to determine their overall performance and effectiveness.

After identifying the best buffer system in phase 1, phase 2 focuses on refinement and optimization. Using DoE, up to four factors are tested, with the base buffer enhanced by additives to assess stability. 

Once the optimal formulation is identified, it is subjected to a confirmation run with higher product concentrations (up to 2 levels), based on customer specifications for the final drug product concentration. 

Phase 3 is conducted to:

(a) assess how different storage conditions and stress tests affect degradation 

(b) determine the best drug substance formulation and long-term storage conditions. While forced degradation studies use harsh conditions and short durations, the insights gained are crucial for understanding real-time impacts and validating degradation detection methods.