Manufacturing and Bioprocessing – Chemical

2019 PharmSci 360

Biotech’s Innovative Approaches to PPQ in a Competitive Market with Aggressive Timelines

Speaker(s)

• CM

  Clare Medendorp, PhD

  Blueprint Medicines

The goal of this presentation is to illustrate innovative strategies for biotech/small pharma to achieve a successful process validation. The main topics of this discussion will center around partnering with the right CDMO that fits with the company's philosophy, creating a design space with less, and engaging with the regulatory agencies to obtain their support. While the main focus of this talk is geared towards process validation, it also focuses on an overarching goal of delivering transformative medicines to patients with cancer.

Learning Objectives:

• Explore other approaches to process validation.
• Discuss strategies for process understanding with limited API.
• Examine interactions with regulatory authorities to gain support.