SCALING FOR COMMERCIALIZATION: CONSIDERATIONS FOR LARGE-SCALE API PRODUCTION

As programs progress through the clinic stage and require scaling to larger-batch sizes, a seasoned commercial partner is critical for program success. Key considerations such as risk mitigation, production scalability, regulatory filing support, and specialized technological capabilities should be thoroughly evaluated. In this webinar, we take a look inside our latest capacity expansion for large-scale GMP API production located in Darmstadt, Germany. With a commitment to phase-appropriate quality, flexibility, and sustainability, the right CDMO partner can help navigate the complexities of large-scale programs.