Considerations of Critical Formulation and Syringe Parameters during Pre-Med Syringe Product Development

摘要

The development of protein products in pre-filled syringes is quite challenging. Typically, there are several product attributes that are desired for protein products in pre-filled syringes (PFS) that are used for subcutaneous or intramuscular delivery [1]. A low injection volume is preferred, but a low injection volume may require a high protein concentration for the formulation. Higher protein concentrations may be associated with higher rates of impurity formation and higher manual forces needed to operate the syringe. A small needle size is preferred for pre-filled syringe products, but a smaller needle size can also result in high forces required to operate the syringe. For efficient development of protein products in pre-filled syringes, it is important to understand how the product stability and performance is affected by both formulation and syringe parameters such as protein concentration, pH, and needle inner diameter.