Why Many CDMOs Struggle with Semi-Solids and What Sponsors Should Look For Instead
Semi-solid formulation development, process development, and commercial manufacturing occupy a niche area within the pharmaceutical industry. This work is highly technical, operationally demanding, and often underestimated.
Many CDMOs claim semi-solid capabilities because they possess basic mixing and filling equipment and capacity. Sponsors frequently discover, however, that true expertise in creams, ointments, gels, lotions, and other semi-solid products requires far more than simply filling batches into tubes or jars.
The difference between basic capability and genuine semi-solid development and scale-up expertise is often where development timelines begin to suffer.
Semi-Solid Products Require More Precision Than Many Realize
At first glance, semi-solid formulations can appear operationally simple. In reality, they introduce a different kind of complexity.
These products depend heavily on precise process control to maintain appearance, microstructure uniformity, emulsion stability, rheological properties, and long-term performance. Even small inconsistencies in Critical Processing Parameters (CPPs) can impact the final drug product in terms of physical and chemical attributes.
Many manufacturing facilities are designed for broader pharmaceutical production but lack the specialized process know-how required for semi-solid systems. Sponsors often discover this only after development challenges begin to emerge.
Equipment Alone Does Not Define Expertise
One of the biggest misconceptions in outsourced manufacturing is that equipment defines capability.
Owning homogenizers, mixing vessels, or filling lines does not automatically translate into successful semi-solid development and commercialization. The real differentiator is understanding how formulations behave under manufacturing conditions and how subtle processing variables influence final product quality.
Semi-solid formulations are highly sensitive to heating and cooling profiles, internal energy variation, charge differences, shear stress, order and timing of ingredient addition, and air entrapment. Manufacturing teams without deep formulation-process expertise may struggle to troubleshoot these variables effectively when problems arise.
Sponsors frequently encounter this during late-stage, larger scale development when batches suddenly exhibit instability, inconsistent texture, separation, non-uniformity, or unexpected analytical variability.
Organizational Structure Often Creates Hidden Problems
Another major challenge is the separation between formulation, process development, analytical, and manufacturing teams.
Some CDMOs operate in highly segmented structures where development scientists, quality groups, and production teams work independently with limited collaboration. For semi-solid products, this disconnect can create significant operational risk.
Successful programs require close collaboration between formulation development, process development, analytical development, process engineering, scale-up planning, manufacturing operations, and quality oversight.
Without that integration, small process changes can trigger larger downstream problems that become difficult to diagnose quickly.
Sponsors Need to Look Beyond Capacity Alone
When evaluating CDMO partners for semi-solid manufacturing, sponsors often focus heavily on facility size or production capacity. While important, those factors rarely predict long-term program success.
The more important question is whether the organization truly understands semi-solid behavior from development through commercialization.
Sponsors should evaluate how early manufacturing teams become involved in development planning, how process risks are assessed during scale-up, and how analytical capabilities support troubleshooting efforts throughout the program lifecycle.
Those operational details often reveal far more about a CDMO’s real capabilities than equipment lists or facility tours alone.
Why Specialized Experience Matters More Than Ever
Semi-solid products continue to grow across pharmaceutical and consumer healthcare markets, while formulations themselves become increasingly sophisticated.
Sponsors now need manufacturing partners capable of balancing technical formulation challenges with commercial production realities simultaneously.
At CPL, semi-solid manufacturing is supported by an integrated approach that combines formulation understanding, process development, scale-up planning, analytical support, and manufacturing execution within a unified operational framework.
That experience becomes especially valuable for sponsors seeking flexibility, responsiveness, and long-term manufacturing consistency as their programs advance toward commercialization.
The Right Manufacturing Partner Helps Reduce Long-Term Risk
Semi-solid manufacturing challenges rarely resolve themselves. They are either prevented early through carefully executed formulation development, process development and a maintenance of process discipline, or they emerge later as delays, deviations, and costly reformulations.
For sponsors, selecting the right CDMO is not simply about outsourcing production capacity. It is about finding a partner capable of protecting formulation integrity throughout development, transfer, scale-up, and commercial manufacturing.
As semi-solid formulations continue to evolve, specialized expertise will only become more important for companies looking to move products to market efficiently and reliably.