The effects of supply chain issues are often most noticeable at the consumer level, manifesting as product shortages or recalls. However, these problems typically originate much earlier in the process — sometimes as far back as formulation. By identifying and addressing issues at their source, we can create a more robust and efficient supply chain.
Let's start by examining the drug formulation stage, a critical early step in pharmaceutical development. In this article, we'll discuss the key players involved, the challenges they face, and how a well-planned approach to drug formulation can set the stage for smoother operations throughout the entire supply chain.
Stakeholders in the pharmaceutical industry
To understand the supply chain, we first have to understand its key players. Each of these stakeholders represents an important step in the process of getting medicine to patients.
Government organizations often initiate and help fund certain types of drug development based on the needs of the population.
Drug sponsors secure the primary research and funding. They are ultimately responsible for bringing the drug to market.
Raw material suppliers provide the essential ingredients and materials needed for drug production, including active pharmaceutical ingredients (APIs) and excipients.
Contract development and manufacturing organizations (CDMOs) like American Injectables specialize in drug development and manufacturing.
Regulatory agencies such as the FDA in the United States oversee the approval and regulation of pharmaceuticals to ensure safety and efficacy.
Logistics providers specialize in maintaining strict environmental requirements for drug storage and transportation.
Wholesalers and distributors purchase drugs from manufacturers and distribute them to various pharmacies, hospitals, and, ultimately, to patients.
3 key challenges and solutions in the pharmaceutical supply chain
COVID-19 made it very clear that the pharmaceutical supply chain is not immune to disruption. While the pandemic exacerbated delays and shortages, many of those challenges persist today. Explore how a strong approach to quality, compliance, and visibility during formulation development can help avoid issues further down the line.
Quality assurance
Drug development is a complex, time-consuming, and expensive process. Naturally, drug sponsors look for ways to make it quicker and cheaper. Often, they can achieve that by partnering with a foreign CDMO for formulation development. The catch? Not all CDMOs have the same standards of quality. Drug sponsors may cut costs but pay for it in other ways, leading to the eventual unraveling of the pharmaceutical supply chain.
The U.S. government is trying to prevent that by introducing legislation such as the BIOSECURE Act which prevents U.S. drug sponsors from getting federal funding if they work with certain “companies of concern.” Rather than wait to be forced by legislation, there is an easier way: work with high-quality, high-transparency CDMOs. It may cost more but could be the difference between your drug making it to market or not.
Regulatory compliance
Formulation development is a major piece of the regulatory puzzle. Not only must drug makers conduct all the necessary studies to prove their formulation is safe and effective for clinical trials, but they must also document the results appropriately. Failing to meet these requirements can cause the FDA to delay projects by months (which can disrupt funding, fulfillment deadlines, product expiration dates, and more).
Drug makers must pay close attention to regulatory requirements to prevent delays in the supply chain. This goes hand in hand with quality assurance. Ensuring all formulation studies are conducted in compliance with FDA standards is one thing. Preparing manufacturing batch records, technical reports, development reports, and Chemistry Manufacturing and Control (CMC) documents is another. Drug sponsors should ensure they’re working with a CDMO that will both meet regulatory standards and thoroughly document every step.
Supply chain visibility
The pharmaceutical industry is not known for its transparency. While being protective of information access makes sense especially when it comes to intellectual property, a general lack of communication will cause serious supply chain issues. Mayra Velazques, QC Manager at American Injectables, offers an example. “Microbiology testing — by design — takes seven days,” says Velazques. But in her experience working with some other organizations, that doesn't stop people from over or underestimating the timeline. While this can satisfy clients in the short term, it can also create negative ripple effects.
With so many moving pieces, every stakeholder in the supply chain must be as transparent as possible — even when that requires recalibrating expectations. 
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Drug formulation development is a pivotal step in the pharmaceutical supply chain. Paying special attention to quality, compliance, and visibility can help prevent major delays down the road.
If you’re looking for a CDMO that can keep up, learn more about American Injectables. A U.S.-based CDMO, we offer expertise in developing complex sterile injectables. Talk to our formulation experts about collaborating on your next project.
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