Introduction to Protein Formulation Basics, Formulation Development for Therapeutic Proteins, What is a Formulation?
Introduction to Protein Formulation Basics, Formulation Development for Therapeutic Proteins, Biopharmaceutical Therapeutic Products
Introduction to Protein Formulation Basics, Formulation Development for Therapeutic Proteins
Each protein product has unique requirements for the optimal formulation.
Biopharmaceutical therapeutic products are proteins. Many challenges at all stages of development that have to be addressed, and overcome, to develop a successful commercial formulation of a therapeutic protein product.
A successful formulation must be designed so it can be manufactured utilizing an efficient, consistent manufacturing process at commercial scale. Must remain stable during production, shipping, storage and delivery to the patient, to prevent degradation that may change the protein’s structural or chemical properties. It must be deliverable from its commercial container/closure system into the patient, and ultimately to its therapeutic target. It must be convenient to use, and commercially viable in the marketplace. And it must meet stringent regulatory requirements.
It is extremely challenging for the formulation scientist to achieve these complex goals while obtaining the most important goal of a successful formulation – maintaining patient safety.
Formulation is the product dose that is given to a patient and includes the therapeutic protein and any other components such as excipients.