API clinical supply, or API clinical trial supply, is defined as the supply of Active Pharmaceutical Ingredients (APIs) required for clinical trials. The core of any good clinical supply chain system is supply management that addresses all of the nuances of clinical supplies production.
Clinical supply, or clinical trial supply includes 24-hour collection and delivery of biological specimens, investigational drugs, kits and other study materials such as APIs and Finished Dosage Forms (FDFs) along with cold chain services including temperature-controlled packaging, etc.
Clinical supplies (CS) can be a rate-limiting factor for the initiation of studies because of factors such as insufficient bulk material, inadequate forecasted demand, accumulation of delays (such as pharmaceutical manufacturing delays), or a sudden acceleration in the timeline for the study's start.
Compared to their commercial counterparts more advanced in the maturity curve, clinical supply chains face greater challenges from both demand and API supply perspectives. Furthermore, unpredictable patient enrollment leads to fluctuating demand signals, frequently causing supply disruptions.
Various pharmaceutical organizations including CDMOs (Contract Development and Manufacturing Organizations) which offer API manufacturing or API production and have clinical manufacturing capabilities can offer API clinical supply manufacturing and packaging services along with commercial cGMP manufacturing of APIs.
To ensure successful manufacturing of Active Pharmaceutical Ingredients (APIs) during clinical trials, it pays to work with a Contract Development and Manufacturing Organization (CDMO) or a Contract Research and Manufacturing Services (CRAMS) provider with deep expertise and experience in clinical trial molecules or APIs.
Such organizations can offer integrated API clinical trial material development and manufacturing services. The CDMO should uphold the highest current Good Manufacturing Practices (cGMP) to avoid cross-contamination or other factors that could impact the quality of the clinical trial supplies.
However, contracting with a Clinical Research Organization (CRO), CRAMS or Clinical Manufacturing Organization (CMO) may be more efficient for offering integrated API clinical trial material development and manufacturing services. They can take sponsors through every step of the way in the lengthy drug development process all the way through manufacturing and may have a strong record of getting required clinical trial materials ready in time for the launch of clinical trials.