For many years, pharmaceutical manufacturers have focused on increasingly stringent supplier certification requirements and other measures of this nature in attempts to reduce risk within their supply chains. Only in recent years have manufacturers recognized that they alone must own and manage the risks associated with their products in a manner that ensures the utmost protection for patients, maintains the integrity of their supplies, minimizes drug shortages, and achieves product development milestones.
Regulatory and quality violations within the supply chain, clinical holds, and capacity challenges represent the most significant risks to supply integrity that pharmaceutical manufacturers must manage.
Regulatory and Quality Risks
Quality issues and compliance violations can occur at any point in the supply chain, putting an entire drug product at risk. Warning letters, production problems, and facility shutdowns at raw material, intermediate, Active Pharmaceutical Ingredient (API), or final drug manufacturing facilities can jeopardize supply.
The complex, highly global natures of many pharmaceutical manufacturers’ supply chains create even greater risks. High percentages of pharmaceutical raw materials and of intermediate, API, and finished drug products themselves are imported from developing markets, which means they face a higher risk of being of suboptimal quality. These shortfalls can have a profound impact on drug shortages.
Supply disruptions can result also from a sole-source manufacturer ceasing operations, wars that disrupt importation, and other factors. In fact, a high percentage of drug shortages in recent years resulted from quality issues with raw materials, including impurities, microbial contamination, and chemical instability.
Investigational New Drugs (IND) can be placed on hold to further assess the quality of the investigational product and ensure patient safety before the new drug is given to humans if significant concerns regarding patient safety arise. When applications are put on clinical holds, the most commonly cited deficiencies leading to these holds are product quality or facility compliance issues, followed by clinical and toxicology issues.
Contract Development and Manufacturing Organization (CDMO) Capacity Challenges
A CDMO-rooted supply disruption is one of capacity. A drug developer simply might not be able to fulfill its capacity commitments because it is unsure of the speed of the drug approval process or even about the market demand. If the actual drug supply needs exceed the expectations or if the needs do not align as planned, the CDMO may not have the capacity available to make the required product.
Consequences of Supply Disruptions
The consequences of supply disruption can be extremely significant. Access to a lifesaving drug might be restricted for some patients. There are revenue and profit-loss ramifications if a drug company cannot sell what it does not have. Furthermore, for venture capital-backed small and mid-sized companies, missing clinical milestones can mean a loss of funding. Such funding losses have financial ramifications; however, they can also mean that a drug targeted to a patient population in need does not make it to the market.
Protection from Supply Disruptions
Propelling our extensive experience in the CDMO industry further, Alcami has been studying supply disruption risks carefully. We have also been thinking extensively about what we can do to help solve this challenge. When many CDMOs detect an acute need or risk, they take advantage of the situation by raising service prices or demanding excessive capacity commitment requirements. Alcami decided to take the opposite approach. As a result, we have created Protect Your Brand™, a unique offering designed to support pharma and biotech companies pursuing a dual source strategy.
We have assembled a service offering that enables pharmaceutical companies to have a backup supply plan in place for raw materials, intermediates, APIs, or finished drugs. Most importantly, we allow Protect Your Brand clients to commission us only for the services and readiness they actually need. Stay tuned for future posts, which will explore Alcami’s proprietary approach to supply-chain risk assessment and our risk-reduction strategies.