Jenna Brager, PhD, RN, MS
Vice President of Drug Development for MyMD Pharmaceuticals, Inc
Most pharmaceutical companies outsource drug manufacturing to a contract manufacturing organization (CMO). These organizations typically support drug development, manufacturing and commercial production, documentation of compliance with FDA regulatory requirements, pre-formulation, development of drug formulation, conduction of stability studies, method development, pre-clinical and phase I/II trials, and providing late-stage clinical trial materials, to name a few.1
Even though CMOs are able to provide an array of support services provided, there are many challenges that pharmaceutical companies must be aware of to prevent issues as clinical trials commence.
Challenges Facing Contract Manufacturing Organizations (CMO)
Lack of Transparency
One of the most common manufacturing issues faced by pharmaceutical companies is the lack of transparency when problems arise. It becomes increasingly challenging to prevent and/or avoid testing missteps if the CMO fails to report protocol deviations or incident reports in a timely manner, if at all. Once a problem is identified, the difficulty quickly becomes tracing problems to its source.2
Quality Control
Everyone wants to save on the cost of production, but not at the expense of quality. Quality materials, trained and capable labor, and efficient production processes are necessary for creating a finished product you are proud to market. Choosing a facility with effective controls at all stages of production is vital. Quality control is especially critical when you are introducing a new product.3
Skilled Labor Shortage
A major factor impacting manufacturing is the lack of skilled labor. Due to staffing challenges caused in part by the pandemic, inexperienced laboratory technicians and analysts are oftentimes required to handle complex drug product. This could lead to issues with testing results, adhering to the sampling timepoints outlined in protocols, and improper storing of the drug product. These types of mistakes may potentially lead to costly delays by impacting clinical supply and regulatory submissions.
To combat these challenges, it is important to identify a qualified and seasoned CMO well-equipped to handle the specific drug product who can adhere to sensitive timelines. This can be supported using automation, but the fundamental issue of limited skilled labor will remain.4
Loss of Control
Pharmaceutical companies must understand that outsourcing may result in losing some element of visibility and control over the production process. This has several implications for the company, including:
- Loss of critical knowledge and skills around production techniques
- Supply chain issues related to poor quality (as mentioned above)
- Shipping challenges
These vulnerabilities have the potential to lead to increase costs and extended production schedules.5
Summary
In the pharmaceutical industry, the market continues to evolve finding new options to bring more FDA approved drug products to market quickly and cost effectively. The major dependence on outsourcing of the development and manufacturing of drug products by CMOs fills critical gaps for almost any pharmaceutical company and is expected to continue or even accelerate over the next few years.
Strategic partnerships between pharmaceutical companies and CMOs are crucial for overall company growth in a highly competitive pharmaceutical market. As the number of CMOs continue to increase, pharmaceutical companies must choose wisely and do its due diligence to ensure that the CMO adheres to cGMP standards (i.e., for sterile facility, manufacturing processes, formulation development, etc.) to assure patient safety and drug quality.1
References
- ADatex. (2021). WAREHOUSE BASICS: What is Pharmaceutical Contract Manufacturing? Pharma contract manufacturers help fast track new drug products to market.
- MetaOption. (2021). Top 6 Challenges Faced by Pharmaceutical Supply Chains.
- Genimex. (2020). Overcoming the Challenges of Contract Manufacturing.
- Balfour, H. (2022). Key challenges for bio/pharmaceutical manufacturing 2022.
- Etq. (2016). 4 Pitfalls of Contract Manufacturing (and How to Avoid Them)
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Jenna Brager, PhD, RN, MS, is the Vice President of Drug Development at MyMD Pharmaceuticals, Inc. Prior to joining MyMD, Dr. Brager served as the Director of Clinical Research for LifeBridge Health and was a clinical investigator at Johns Hopkins Hospital. Dr. Brager received her B.S. in Nursing from the University of North Florida, graduating cum laude and received her Ph.D. from the Johns Hopkins University School of Nursing.
Dr. Brager welcomes comments, questions, and requests for future blog topics. Please email jbrager@mymd.com.