4 Critical Strategies For Successful Biologic Process Development

By Edyta Bartusik-Czubek, Ph.D., Director of Research and Development; Marta Bednarek, Director of Manufacturing and Operations; and Dorota Jaros, Ph.D., Regulatory and Validation Division Manager

In the journey to patients, a drug sponsor cannot underestimate the importance of optimizing process development (PD) for their biologic. The PD stage is a critical moment to mitigate risk, ensure high quality, and bolster speed and efficiency. Furthermore, with strategic PD, a drug sponsor can save time and money by avoiding mistakes or delays further down the line. In the pursuit of maximizing the PD phase, a sponsor’s choice of CDMO is critical. An experienced CDMO will have the knowledge and experience to balance quality, compliance, cost savings, speed, and scalability, all while maintaining a transparent and collaborative relationship with the sponsor.

If you are a drug sponsor hoping to maximize the benefits of your PD, consider where you can implement optimization, how you can build greater product understanding, why it is beneficial to leverage a platform approach, and how to choose the right CDMO to help you with all of the above.

Download the full article to learn more about optimizing your biologic PD.