By Serena Smith, Director of Strategic Customer Engagements, Thermo Fisher Scientific
Biologic medicines are changing the lives of more and more people around the world, but the increasing complexity of the molecules means that developing the right manufacturing process isn’t easy. I’ve spent over 15 years working in the industry on viral vaccines and therapeutic proteins, focusing on upstream process development, scale-up and cGMP manufacturing. I’ve developed processes for over a dozen different molecules and I often think about what makes a “good” or “optimized” process – and where the pitfalls lie. To me, an optimized process produces highly purified material in a minimal number of batches to meet your clinical timelines and prepare for commercial launch, all while managing cost, quality and supply. In addition, an optimized process must streamline operations, improve robustness and consistency, and minimize the opportunity for failures. You’ll also need to consider engineering controls to prevent contamination events or the introduction of adventitious agents. All of this should result in long-term manufacturing success.