Overcoming Challenges Associated With Biologic Drug Formulation And Development

By Victoria Morgan, Director, Segment Marketing, Global Biologics

Standing front and foremost in biologic drug formulation is the optimization of safety and efficacy while ensuring quality and stability during manufacturing. Biologic manufacturing subjects the formulation to different stresses and conditions that may compromise quality and stability. Recently, the requirement for the development of subcutaneous formulations for high dose drugs, such as monoclonal antibodies, at high protein concentrations has created additional challenges, including degradation.

Recent formulations have been designed to minimize protein aggregation and decrease viscosity, which has led to successful manufacture of many biologics. Current challenges focus on dealing with the high drug volumes and increased concentration, which get pushed upstream to the drug formulators. The panacea of successful drug formulation would be: liquid stable, <1mL, viscosity of <10cP and an injection time of <15 seconds. These product attributes also need to consider the patient as lack of patient compliance will override any novel development the drug formulators make.