During freeze-drying, biopharmaceutical and other products require protection against dehydration stress during freeze-concentration and drying. Therefore, a suitable formulation strategy is essential to guarantee the long-term stability of drug products. This strategy could include adding protectants to withstand the dehydration stress, selecting a suitable buffer to maintain a constant pH throughout the process, or including surfactants to inhibit adsorption. However, because of the different natures of proteins, lipid nanoparticles (LNPs), and other ATMPs, each biopharmaceutical requires a customized formulation approach.

At RheaVita, we have the in-house knowledge and experience to conduct and support the formulation development of all types of drug products. We apply a synergistic approach of simultaneous formulation development and optimization of relevant process parameters, while minimizing the consumption of material. In creating the optimal development strategy, we consider the impact on both relevant critical quality attributes and also on the process performance.

For more information about RheaVita’s formulation development and optimization services, please contact our team of formulation specialists via info@rheavita.com.