In the realm of Sterile Injectables (SI), sponsors come in a variety of sizes and with a range of experience levels. The oncology segment, which will drive much of the growth in the SI market (expected CAGR of 9.1%) in the coming years, is the focus of many drug developers with significant differences when it comes to history, footprint and experience. The same is true for contract development and manufacturing organizations (CDMOs) and the dynamics of these outsourcing relationships have a huge influence on project success.
CDMOs work with all types of sponsors, from small, emerging, sometimes virtual companies, to large biotech and pharma companies. To accommodate such variety, CDMOs must make every possible effort to customize their operations to the sponsor’s product technical needs without compromising quality or safety. The two mottos, “Right the First Time” and “No Cutting Corners Allowed” are pillars for a CDMO.
Sterile injectable product development and manufacturing is a complex endeavor that requires deep expertise backed by extensive capabilities. Where CDMOs and sponsors are bringing medicines to the patients who need them, fluid and honest conversations are essential to ensuring a successful product launch in a timely manner. In this white paper, we discuss how a small or medium size biotech or pharma company can benefit from the experience and assistance provided by a CDMO.