The outsourcing of pharmaceutical clinical supplies has greatly expanded over recent years. While dosage forms and packaging have traditionally been the primary focus, clinical stage active pharmaceutical ingredients (APIs) are increasingly taking center stage, and there is much to learn about the outsourcing of these materials. Clearly, without sufficient quantities of the necessary API, clinical studies cannot occur.
Outsourcing the supply of APIs for clinical studies has emerged as a highly practical, cost-effective, and widely embraced choice among small to mid-size drug developers that lack the infrastructure required for in-house production of small molecule APIs and reference standards. Entrusting the manufacturing of clinical trial APIs to a reputable API-focused CDMO specializing in small molecule development and production, like Purisys, can help these organizations to enhance efficiency, accelerate timelines, significantly reduce their own research and development expenses, obtain clinical supplies, and expedite clinical trials.
Beyond that, CDMOs offer drug sponsors operational expertise in chemistry, manufacturing and control (CMC) technologies, Good Manufacturing Practice (GMP) facilities, quality, safety, and environmental management systems. Full-service CDMOs also provide regulatory filing support and may specialize in specific chemistries or compound classes, such as cannabinoids or other compounds with potential therapeutic benefits.
There are many smaller biotech companies whose research is dependent on a domestic U.S. funding source (such as NIH, NSF, NIDA, BARDA) that require domestic manufacture of clinical trial APIs. In such cases, these companies must find a manufacturing partner capable of domestic manufacture.
Large pharmaceutical companies may also employ CDMOs if they lack a domestic manufacturing footprint, need expedited delivery or have internal capacity constraints (lack of R&D resources) to produce material for clinical trials. Companies developing controlled substances, including a recent uptick in companies researching psychotropics, must have licenses required by the Drug Enforcement Administration (DEA) to legally research, manufacture, test, import, export and distribute APIs.
What to look for in a small molecule API-focused CDMO partner
When selecting a CDMO, there are several factors that should be considered:
Sponsor companies should prioritize a customer-oriented partner that offers proactive solutions. Large global CDMOs often act conservatively and cause delays during the contracting process, wasting valuable development time. Smaller biotech companies must consider lead time and potential changes in trial timelines, ensuring the CDMO can pivot quickly to meet accelerated supply needs. It’s crucial to assess the CDMO’s ability to support future trials and commercialization plans, particularly in Phase III. Balancing scalability with ease of collaboration is essential, as sponsors need a partner focused on their needs and responsive to input. A customer oriented CDMO understands the client’s goals and acts efficiently to achieve them.
A successful CDMO should have proven technical capabilities. This applies to equipment, capacity, development experience/skill and knowledge across production and analytical development. Choosing a CDMO that has a track record in delivering cGMP clinical stage materials across multiple chemistries and sponsors is critical, especially since many CDMOs who claim to have clinical stage expertise have a limited complex cGMP API synthesis track record.
It’s best to always work with a CDMO that has global regulatory and quality experience that has supplied trial materials to many global clinical studies. A CDMO who strictly adheres to regulatory guidelines and has extensive knowledge on the regulatory processes enhances the sponsors chances of a timely completion of the trial, and ultimately an approval. Partnering with a reliable CDMO that has well-maintained GMP facilities, a strong regulatory track record, and a robust quality system can significantly lower any regulatory risk.
Not all clinical stage drug manufacturers perform commercial manufacturing routinely and vice versa, making them subject to different regulations and inspection intervals, etc. At Purisys, we manufacture APIs spanning preclinical to late-stage clinical studies, but also routinely manufacture products for niche (including orphan drug) commercial purposes.
Purisys also custom manufactures new chemical entities and reference standards for pharmaceutical customers. As such, Purisys is a commercial manufacturer as well as a clinical stage CDMO that undergoes ‘Six Systems GMP Inspection’ with the FDA. This is a systems-based approach to GMP and is aimed at ensuring a robust quality system model for pharmaceutical products. Purisys is routinely inspected for compliance on a regular cadence by the FDA to meet the high standards necessary for clinical and commercial manufacturing.
After selecting the right CDMO, there are a number of strategies to follow to ensure a successful partnership. We’ll cover those in our next blog. In the meantime, to learn more about our CDMO services and how we can assist with your next clinical trial, contact us today.