Back In 2017 we correctly predicted that API development and manufacturing capacity would tighten. Since that time CDMO capacity constraints have indeed continued to plague the pharmaceutical industry. Most recently we have all experienced the consequences of limited capacity as even the largest pharmaceutical companies could not, on their own, quickly produce sufficient quantities of COVID-19 vaccine to protect the world from the SARS-CoV-2 virus and inhibit the rise of variants. As much needed treatments for COVID-19 are developed, we can anticipate great need for CDMO services. But will capacity constraints also slow treatments, as they have for vaccinations?
Many CDMOs have been pressed into service for COVID-related projects during the pandemic. However, there are many other reasons for reduced capacity, including the following:
- Increases in demand increases for specific drugs.
- Growth in new drug discovery projects.
- The growing number of virtual biotech and pharmaceutical companies with very limited development capability and no manufacturing facilities.
- Many patents coming close to expiration dates, triggering a multitude of generics projects.
- Geopolitical wrangling, resulting in a pullback from developing APIs in and sourcing raw materials from China in favor of returning to the West in order to secure supply chains.
- The COVID-19 pandemic, which no one anticipated, and which has wreaked havoc with supply chains.
- Realization by governments that stockpiling of vaccines and treatments is necessary for protecting their citizens from future pandemics and supply disruptions.
- The limited number of CDMOs with both drug substance development and cGMP manufacturing plants that can smoothly transfer technology from lab to manufacturing suite with minimum delay.
As a result of these factors, demand for APIs at the kilo scale is only increasing as targeted therapies and generic drugs, as well as complex molecules, become key requirements for pharmaceutical company growth.
What CDMO capacity refers to and what to look for
In this competitive landscape, finding the right CDMO for an API development or manufacturing project—one that is right-sized for the project–can be more difficult. There are many choices, covering the gamut from the big players whose revenues are in the hundreds of millions to small labs staffed by a few people who can provide only initial chemistry.
A sponsor’s key goal is to choose a qualified partner that has the right resources and expertise to deliver the API or NCE as quickly and cost-effectively as possible. When a CDMO talks about its capacity, it can mean many things. These include:
- Having a broad variety of types and sizes of equipment such as reactors, driers, filters, and the now required measurement capabilities.
- Having experienced scientific and project management staff with a solid track-record for success.
- Having the ability to meet a range of capacity needs, from small-scale, low volume projects such as API supply for orphan drugs or for Phase 1 clinical trials, to commercial manufacturing at large scale for blockbuster drugs.
- Having the lab or manufacturing suite time available to take on the project, which can be difficult to determine given the uncertainty that is a hallmark of chemical development.
- Having the knowledge, flexibility and experience necessary to triage projects and know when to give priority to those that are time-sensitive without incurring delays in other projects or creating project backlogs.
- Having enough work shifts to allow the chemistry to evolve and assure batches remain at prescribed levels. Seqens CDMO NA, for example, runs 24/7 with three shifts on weekdays and 2 shifts on weekends, which provides the flexibility to add additional weekend shifts when needed.
- Being the right sized CDMO. CDMOs that mostly produce blockbuster drugs may have little capacity left over for smaller projects, which may be less of a priority. On the other hand, too small a CDMO will require costly, time-consuming technology transfer for project scale-up.
- Having international capacity that can seamlessly move a project to a different locale should a natural disaster occur, as when Hurricane Maria brought pharmaceutical manufacturing to a standstill in Puerto Rico, which was the only site manufacturing certain drugs.
- Integrating drug substance development and cGMP manufacturing to reduce the delays and costly duplicative work that technology transfer to a different organization entails.
How early should you make capacity decisions?
Shrinking CDMO capacity issues make it imperative for sponsors to plan earlier. There is no longer the luxury of waiting for clinical trial data analysis, or to see how an approved drug is doing on the market, before making capacity decisions. Today, capacity decisions need to be made earlier in the process in order to reduce risks at both ends of the spectrum: undercapacity or overcapacity.
But how early? Factors to be taken into consideration include whether the sponsor’s Board is fully committed to the project and will support it going forward. An experienced CDMO will also be able to weigh in with valuable advice such as at what point to order raw materials for an anticipated Phase 3 trial when Phase 2 results have not yet been analyzed, and provide informed Go/No-Go advice on projects.
Summary
Sufficient and scalable capacity is critical to the success of API and NCE projects, but they require more than just having the right equipment. They also require a knowledgeable CDMO partner that has the flexibility and willingness to work with you to do whatever it takes to get the job done.
To learn more about Seqens CDMO NA’s R&D and manufacturing capacity please call us at (978) 462-5555.