Demand for Active Pharmaceutical Ingredients (APIs) at the kilo-scale is only increasing as targeted therapies and generic drugs, as well as complex molecules, become key requirements for pharma growth.
Yet, when an API manufacturer talks about its manufacturing capacity, it can mean a lot of things. It’s not just about the number and size of the equipment it has, such as reactors, driers and filters, but it’s also about the experience of its staff, its track-record for success and its agility in meeting laboratory/small-volume production at scale. After all, when it comes down to it, your key goal is in ensuring that you have a qualified partner that has the right resources and expertise to deliver your Active Pharmaceutical Ingredient (API) or New Chemical Entity (NCE) as quickly and effectively as possible.
Manufacturing capacity also refers to having the lab or suite time to take on the project, which can be difficult to determine given the uncertainty that is a hallmark of chemical development. No CDMO wants costly GMP suites and related equipment and staff sitting idle, so projects must be carefully planned to keep a steady flow of projects. Here at Seqens NA, we try to keep a schedule of projects for three-to-four months out at a time.
Despite the best efforts, however, for many CDMOs production delays in GMP can create a backlog of new projects, and often, projects may need to be triaged to give priority to critical projects with time-sensitive requirements. When working with raw materials and creating chemical reactions a number of uncontrollable issues can arise, so flexibility must be paramount–regardless of manufacturing capacity.
Keeping these challenges in mind and to get a better handle on your CDMO’s capacity to do what it takes to get your API into clinical trials, it pays to ask the following five questions:
- How many shifts do you operate? This is an important question, since many projects require a specific number of hours or days to allow the chemistry to evolve and during this time, operations must continue, machinery must remain on, and temperature and other factors for the batches must remain at a prescribed level. Most CDMOs operate a specific number of shifts. Here at Seqens we typically have three-shifts, operating five days a week, as well as two weekends per month. These are carefully planned so that we can address the maximum number of projects with enough time to complete them without interruption. The benefit of working with a CDMO such as Seqens is that we have the flexibility to add another weekend shift if it’s urgent. Many large manufacturers, however, making batches of block-buster drugs, must give priority to those projects and have no leeway to accommodate or prioritize other projects.
- What are your manufacturing capacity specifications? Your CDMO should be prepared to provide you with a list of its facility size, the reactors and other systems being used and how many of them in each suite, temperature and pressure capabilities and other key capacity information. At Seqens NA, our cGMP manufacturing facility is over 75,000 square feet and is equipped with 22 glass, stainless steel, and hastalloy reactors providing more than 20,000 gallons of total capacity. We also have 3 class 100,000 cGMP kilo suites, a pilot plant (50-200gal) and a production plant (500-2000gal) .
- Do you have global capacity? As API manufacturing continues to move across country borders, having a CDMO with international expertise and resources is becoming invaluable. Regulatory requirements, cultural differences and methodologies can be vastly different from one country to the next, so having a CDMO who can navigate these differences is key. As a part of a global CDMO, here at Seqens NA, we can provide the best of both worlds – a local CDMO that is right in your backyard, along with the support of a network of other advanced manufacturing sites across Europe. This network of sites not only provides the international expertise, but also advanced capacity so we can transfer projects that may require additional support.
- What type of chemistry do you manufacture? It’s important to know where you stand in the scheme of sponsor projects. As mentioned above, CDMOs that mostly produce block-buster drugs may have little capacity left over for smaller projects and you can become less of a priority. On the other hand, it pays to know what they specialize in because CDMOs handling a variety of projects can provide broad experience, SOPs and insights to apply to your project.
- How do you handle urgent, last-minute requests? You should ask your CDMO how it would handle different scenarios to get a better understanding of its flexibility to meet your fluctuating needs. What happens when a mistake occurs that adversely affects the batch? What if we want to transfer manufacturing to you from an overseas manufacturer? Not only understanding its processes and strategy for addressing these issues, but also its willingness to do so, is essential.
Sufficient and scalable manufacturing capacity is critical to the success of API projects, but it requires more than just GMP equipment and system capacity, it requires a CDMO partner that has the flexibility and willingness to work with you to do what it takes to get the job done.
To learn more about Seqens NA’s manufacturing capacity please call us at (978) 462-5555.