64 TWENTYFOURSEVENBIOPHARMA Issue 3 / October 2025 FLAMMA As a drug begins to show promise, those involved with the supply chain must spring into action to ensure that the drug will be available to patients as soon as possible following regulatory approval. Reading the tea leaves is challenging enough, particularly when prognosticators say that you need 200 kg and then a week later revise the amount to 800 kg based on updated projections of the patient population. In other words, you never really know. Working with your suppliers is critical to the success of the molecule. Most often, the API is launched with one CDMO while you prepare to bring in secondary suppliers. Based on your workload, you may be tempted to allow the launching CDMO to take over the sourcing of key regulatory starting materials, or RSMs. Resist this temptation, as it will only lead to problems later on. Managing RSMs and key alpha raw materials Understanding the impact RSMs will have on the cost of your molecule is critical. While this article will focus on RSMs, you can easily substitute the phrase “key alpha raw materials” for “RSMs” as both apply to what you will read. While cost is important, timelines are often more important. You need to ensure not only that your API can be made, but also that you understand the total cost per kg. If you negotiate with the launching CDMO and then try to bring on secondary suppliers, knowing the true cost of the RSMs will help you in comparing costs. Apples to apples is always better than apples to oranges. Smart sourcing dictates have two suppliers providing the RSMs. Why? CDMOs concerned about profit often look to decrease the costs of RSMs, which could jeopardize access to a consistent supply. It is difficult to quickly resolve these shortfalls because RSMs in today’s market are often complex and certainly not commodity chemicals. They aren’t catalog items, they need significant lead times to produce. Since the CDMO marketplace is rather incestuous, it’s not uncommon to find competitors working together and supplying RSMs to one another. The issue is that the API producing CDMO may not have a sourcing group that clearly understands the difference between common solvents/reagents and RSMs.
RkJQdWJsaXNoZXIy MjY2OTA4MA==