10 Ways To Strengthen U.S. API: Part II
By Katie Anderson, Chief Editor, Pharmaceutical Online
Manufacturing more pharmaceuticals in the United States requires attention to the affordability of that process. Only then can the industry satisfy the demand without passing off a large portion of that cost to the patient. To achieve this, strengthening the API supply chain in the U.S is undoubtedly part of the equation.
In part one of this discussion with API Innovation Center president and COO Kevin Webb, we cover investing in more efficient processing technology, collaborating with industry organizations and regulatory bodies to de-risk the investment, developing the workforce and streamlining in the process. Here, we continue that conversation, jumping into KSM sourcing and substitution, utilizing idle space and connecting the dots. The road to strengthening the U.S. pharmaceutical supply chain won’t be easy, but it is manageable.
6. Bring KSM Manufacturing Back to U.S.
“You get back to the not-in-my-backyard scenario, where a lot of the chemical manufacturing producing companies moved offshore, or off to other countries because a lot of people did not want pollutants causing chemical companies in their communities,” he explained.
However, chemical processing has come a long way, and many chemicals are produced with the environment in mind. Webb noted that many of the manufacturing processes used for APIs can be applied to KSMs as well. “There are a lot of efficiencies that can be built into the KSM process, just as we're building it into the API,” noted Webb.
The KSM producers want to be part of the reshoring and supply chain strengthening conversation, according to Webb. “They have to contribute. Like a lot of these other manufacturers, they are trying to figure out what role they play in the process and how they can contribute to a better process.”
7. Substitute KSM For Another Chemical
When KSMs are in other countries, there isn’t always a viable solution to producing them stateside, according to Webb. This is especially true for those chemicals that are only found exclusively in specific countries. In those cases, Webb recommends “peeling back the onion.” In other words, every step of the process is a layer, and for every layer that you solve for, there is another layer of complexity.
In this case, technology such as digital twin can be implemented to see if an alternative chemical can be substituted to still achieve the same outcome.
“Can we substitute it and then create a new synthetic pathway using something else that can be sourced here? And do we have to still have the same outcome? It requires us to be smarter about it. We just need to ask the questions. If it's this chemical, can we modify that chemical, but still then get the same result as we would otherwise? That's where the dialogue is occurring. How can we be smarter? How can we take what we do, what we know, and reapply it so that it can be done here in the United States,” iterated Webb.
8. Utilize Idle Manufacturing Space
Webb noted that there is low hanging fruit in the large U.S. manufacturers that have idle space. In 2022, APIIC conducted a study of generic drug manufacturers to find that 25% of them were not manufacturing to their full capacity. Webb clarified that most had at least a third if not more of their manufacturing line sitting idle. “Just because they are large, doesn’t mean they are producing a lot. It means they have a larger overhead, and a lot of that is because they moved the manufacturing offshore.”
He added that these companies can quickly repurpose their manufacturing lines with new technology within 1-2 years. He also furthered that advanced manufacturing can be quickly repurposed, so a manufacturer can make more API on the same technology.
“Now you have a repeatable process that you can produce another API, and then another API, and then another API. And that is what now allows us to accelerate this process, where what took months now can be done in weeks, if not days, or even hours, to produce an API. So that one-time investment to create for an API now generates an annuity with which that manufacturer continuously now produces that API for Americans to be produced here in the United States.”
9. Start At the Core
There's a subset of drugs that represent the core class of drugs that Americans take, and that list is what Webb wants to focus on at the moment with regard to domestic API production.
By focusing on that core list, we are able to treat most of the disease states in the U.S.
10. Connect The Industry
As we know, the pharmaceutical industry is a complex system of interconnected suppliers and manufacturers, and no one company has the same process. Jump-starting U.S. API manufacturing requires connecting the KSM producers to the API manufacturers and the drug makers, while interjecting the industry associations and state and federal government funding agencies where needed.
This can be a complicated tapestry, but luckily it is one that APIIC excels at. “We look at that entire chessboard of pharmaceutical manufacturing end to end, and we look at how we can integrate and connect all of these parties together. Someone says, I need drug X; can you help me? We activate a project team of manufacturers and components across the country, and everybody has a part to play based upon their ability and their desire and their strategic capabilities,” explained Webb.
The Road Ahead
The road to producing more pharmaceutical API in the United States is complex, but it is necessary and navigable. Though the task may be daunting, now is the perfect time to jump in, according to Webb, with the government and industry focused on a solution.
“We have a window of opportunity here in the United States, where the entire nation and the government is focused on this. Hospitals, pharmacies, drug purchasers, the administration and congress all realize that this is a problem that needs to be solved. With that level of energy focused on the problem, we can work towards an equitable solution on how to do this.”