Development to Delivery: A CDMO’s Guide to Strategic Scale-Up

Bringing a sterile injectable product from development to commercialization requires a seamless scale-up process—one that minimizes risk, optimizes efficiency, and ensures regulatory success. In this exclusive webinar, experts from August Bioservices will discuss the critical factors that make or break a successful scale-up, sharing insights from a CDMO’s unique perspective.

Our discussion will focus on three key perspectives:

  • Talent & Expertise: Scaling a business requires specialized expertise across multiple disciplines—from formulation development and process optimization to analytical testing and regulatory compliance. We will explore how the right talent at each phase of building a sterile injectable CDMO ensures that the right people are in the right roles at the right time, mitigating bottlenecks before they arise.
  • Equipment & Facility Readiness: Having the right infrastructure in place is crucial to scaling a CDMO. We’ll discuss how state-of-the-art manufacturing lines, flexible capacity, and facilities designed to meet global regulatory requirements play a role in accelerating scale-up while maintaining product quality and regulatory compliance.
  • Customer-Centric Approach: A CDMO is more than just a service provider, it’s a strategic partner. We’ll highlight why close collaboration with clients throughout the development and scale-up process is essential, ensuring alignment on goals, timelines, and quality expectations. From early-stage development through commercial launch, our team works as an extension of our clients’ teams, and that collaborative approach ultimately serves to de-risk the process and enable long-term program success.

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