The drug development process is lengthy and complex. All pharma companies are in a rush to get their API developed so they can test their drug in the clinic and get it to market to start recouping the high costs of drug development. To move promising compounds from the lab to the clinic, sponsors put great pressure on themselves—and on their outsourced CDMOs. We get it. We’re used to it. We don’t mind. We in fact enjoy getting GMP projects completed and shipped out—it benefits our business as well. Despite the need for speed, we do not cut any corners in developing and manufacturing the API or functional foods in order for the regulatory process to go smoothly. Our hard-earned reputation depends on it.
As we detailed in Part I of this series about being named an Overall Top Performer in the coveted Life Science Leader CMO award for reliability, we take great pride in delivering the GMP material our customers need in time to meet their pre-determined milestones—the start of a Phase 1, 2 or 3 clinical trial, or for post-approval commercial quantities. Although we won awards in each of the six major award categories, and in addition received six other awards in specialty categories, we consider Reliability to be the among the most vital to sponsors.
To determine Reliability award recipients, Life Science Leader magazine teamed up with Industry Standard Research (ISR). More than 120 contract manufacturers were assessed by 23 performance metrics in ISR’s annual Contract Manufacturing Quality Benchmarking survey.
The criteria ISR uses to assess Reliability
The following are the seven criteria used by ISR to judge a CMO’s reliability:
- All facilities fully owned
- Financial strength/stability
- Flexibility to adjust schedule for special requests
- Has capacity to meet our demands
- Reliable on-time delivery
- Timely project management
- Up-front contingency planning, risk management
We covered the first three criteria—owning the facilities, financial stability, and flexible schedules in Part I of this series. This article will cover measures 4-7b used by ISR and Life Science Leader to assess Reliability.
Has capacity to meet our demands
How much capacity is enough capacity? It’s a very telling question. The fact of the matter is that almost every CDMO has extra capacity. The real question is whether the CDMO has the wherewithal to fully use that capacity. A busy CDMO like ours always has projects starting and projects ending. Because we don’t like to turn away business, we always find a way to take on new or extra projects. As well, we can always dial back or ratchet up business development commensurate with how busy we are. What it boils down to is the ability to think outside the box, and to have exceptional scientists and project managers willing to put in the extra effort required to meet demand.
Reliable on-time delivery
We have a vested interest in our clients’ timelines. If they miss their milestones for getting their drug product produced under GMP and their funding is cut off, it impacts us directly in lost business. Whether we are manufacturing commercial product or developing new material, we are cognizant of the importance of reliable on-time delivery.
On-time delivery of commercial product, which involves making, testing and shipping, is more directly measured. If a company comes to us asking for 10 Kilos of material, with the chemistry developed and a delivery date a few months hence, it’s easy to say sure, no problem….or so it seems. But unforeseen things happen. What if the raw material that was readily available last week no longer is? Or the product isn’t scaling up as expected and needs a new purification method developed?
Such technical issues often require additional resources…and decisions need to be made by the sponsor as to whether they want to put in the additional resources that would be required to maintain their timeline, or to delay. It’s a cost decision sponsors need to make when the unexpected happens. As we’ve said many times, we’re always dealing with new chemistry that can behave in unpredictable ways. When scale-up yields surprises, sponsors have to decide whether adhering to a delivery schedule is more important than providing a high-quality product that may take longer but pass regulatory muster.
As our customers know, we make every effort and go the extra mile to assure reliable on-time delivery. The high marks our customers give us aren’t always because we deliver every product on the day we expect to. A major factor in their satisfaction with us is the frequent communication and collaboration we insist on with our customers. It assures they’re never surprised when something happens that could throw the schedule off.
Timely project management
Our project managers are hands on, engaged in every aspect from the beginning of a project until the end, when the material is shipped. We have a daily huddle where every project in the manufacturing suites and the labs is reviewed. That way everyone involved, including management, knows how each project is proceeding and can communicate with the sponsor to assure quick decision making.
Up-front contingency planning, risk management
Risk is something we try to avoid, and we manage for that. There’s risk of delay, which we resolve with contingency planning that ranges from sourcing raw materials to having more than one group working on a project.
In drug development there’s also the risk that the chemical will not meet FDA approval due to high levels of impurities, incomplete data collection, or not following standard operating procedures. To mitigate that risk we adhere to quality risk management protocols to:
- Identify methods suitable for their intended purpose.
- Qualify and validate early on in the process per ICH Q10 guidelines.
- Develop a sound regulatory strategy.
As Ben Franklin famously said, an ounce of prevention is worth a pound of cure. Ensuring sound quality risk management from the earliest stages of drug substance development can go a long way in saving time and money.
Rapid decision-making a major factor in flexibility
When both CDMO team and sponsor team communicate regularly and often, decision-making is rapid. Our highly experienced project managers are empowered to make decisions. We do not have the type of hierarchical structure common at CDMOs that often causes delays.
As we mentioned in Part I of this series on Reliability our decision-making also involves accommodating requests from sponsors who ask us to move their project to the front of the queue to meet their deadlines. We discuss those requests at our daily morning meeting and rarely let any of our sponsors down when they need us most.
That our sponsors can count on us to provide them high quality molecules is just one reason Life Science Leader and ISI honored Seqens North America with a top Leadership Award for Reliability. Our excellent, resourceful, empowered project managers are another. With contingency plans in place and the flexibility to accommodate prioritization requests when possible, we make decisions quickly and get the work done. Despite the complications of developing new chemistry our sponsors know they can rely on us to put in the extra effort to deliver high quality materials in a timely fashion. As background Seqens NA has focused a lot on reliability over the years. Check out our blog for other articles like “Soaring to New Heights with Quality Control Checklists in API Manufacturing” that discus tips and insights about how to manage projects effectively and efficiently.