How CDMOs With In-House Analytical Capabilities Save Sponsors Risk, Cost, And Time

By Jani Yömaa and Andrés Guerrero

Analytical services are crucial for developing and manufacturing safe biopharmaceuticals. While testing is often outsourced, relying on separate vendors for analysis, development, and manufacturing can introduces technical and regulatory challenges. In response, biopharma sponsors are increasingly partnering with CDMOs that have extensive, integrated analytical capabilities.

Outsourcing analytics also may introduce additional risks and costs. Shipping time- and safety-sensitive samples can compromise quality, causes delays, and increases costs. It also adds logistical and operational complexity, as the CDMO must qualify and audit each third-party lab, and the transfer of analytical methods between labs is prone to variability and information loss.

In contrast, a CDMO with in-house analytics improves efficiency, speed, and data integrity by enabling comprehensive production monitoring and faster process development. This integrated approach fosters close collaboration, allowing teams to make quicker, better-informed decisions, particularly during critical phases like defining Critical Quality Attributes (CQAs) and performing process validation. Further, drug substance release methods developed in-house generally are more reliable and easier to justify in regulatory documents.