Presentation Title: Parenteral Formulations: Tackling Development and Scalability Challenges of Ever-Increasing Formulation Complexity
Abstract: Parenteral injections allow a drug to be administered with up to 100 % bioavailability. Formulating a liquid drug product first and foremost must consider solubility and solution stability of the drug substance. Understanding these properties and limitations can see formulation development culminate in a simple aqueous formulation or develop into a more complex formulation such as an emulsion or dry-powder product. With increased sophistication of payload has emerged the use of liposomal and lipid nanoparticle technology which in itself provides stability challenges but also scalability challenges. Developing a lab-scale process for a complex formulation through to multiple litre GMP manufacturing has many considerations which we routinely tackle at Curia.