Setting The Foundation For Sterile Injectable Success With A Collaborative CDMO Partnership

The sterile injectables (SI) market is experiencing rapid growth, driven largely by the expanding oncology sector, which is projected to grow at a 9.1% CAGR in the coming years. Biotech companies developing these therapies vary significantly in size, resources, and expertise—ranging from small, emerging, and sometimes virtual firms to large, well-established biopharma companies. Similarly, contract development and manufacturing organizations (CDMOs) differ in their capabilities, experience, and operational scale, making the dynamics of these outsourcing relationships crucial to project success.

To effectively support such a diverse biotech landscape, CDMOs must adapt their approach to meet each product’s unique technical and regulatory requirements while maintaining uncompromising standards of quality and safety. Flexibility in development, manufacturing, and supply chain operations is essential, ensuring that both early-stage innovators and global pharmaceutical leaders receive tailored support at every phase of the commercialization journey.

At the core of a successful CDMO partnership are two fundamental principles: “right first time” execution and an unwavering commitment to quality—where cutting corners is never an option. By prioritizing scientific expertise, regulatory excellence, and operational efficiency, CDMOs play a vital role in bringing sterile injectable therapies to market safely and efficiently, ultimately improving patient outcomes worldwide.

In this white paper, we explore the benefits an experienced and flexible CDMO can provide biotechs and pharma companies of all sizes.