Suppose your house needs major construction and you have time constraints—it’s May and your children are starting school in September. You hire a contractor, impressing on him that you need to be back in the house by the time school starts since you’ve moved during construction. When searching for that contractor, you wanted to find someone who will start when they said they would and come prepared with the tools and supplies they need to finish the job. You also wanted to know that once they start construction, they will continue working on your project and not leave it only partially completed, going off to another job before finishing yours and leaving you in a bind. Although the contractor may not be able to tell you exactly how long the job will take—given that much depends on what he and his crew find once they start working—they should have a pretty good idea of the project’s duration and cost.
Likewise, drug developers rely on their outsourced CDMOs to be reliable so they can have the GMP material they need in time to meet pre-determined milestones—the start of a clinical trial, or sufficient commercial quantities once a product is approved, for example. That’s what reliability is largely about, and we were honored to be recognized for our commitment to our sponsors: we were named an Overall Top Performer for Reliability by Life Science Leader, whose CMO Leadership Awards are based on actual pharmaceutical companies’ experience with CDMOS. Although we won in each of the six major award categories, and received six additional awards for specialty categories, we consider Reliability to be the among the most vital.
This two-part series will focus on how Life Science Leader defines Reliability and why those criteria are important factors for sponsors to consider when choosing a CDMO.
To determine 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
This article will cover the first three criteria; Part 2 will cover items 4-7.
All CDMO’s facilities fully owned
When a CDMO owns its facilities, it prevents problems like the one we encountered a number of years ago. We contracted with an offshore company for production of an intermediate material and received a call that the product would be late. Why? It turned out the operators of the facility hadn’t paid their rent and the landlord locked them out of their lab, causing the delay. It’s worth checking.
Sponsors want to be sure the CDMO is stable. They often do this by checking publicly available information to determine a CDMO’s financial strength – such as Dun & Bradstreet and tax filings. They also ask us, typically by preparing a questionnaire that probes such things and asks general financial questions to better gauge the financial health of the business.
As a busy CDMO, our financial strength and stability have been verified year after year. Fiscally weaker CDMOs may provide a low bid for projects, hoping to reduce idle time in their plant.
I would suggest that when developing drug substances, focusing on the cost of the API’s development or manufacturing is the wrong thing to focus on. What’s more important is knowing you can rely on the CDMO to supply high quality material so the clinical trial can start and that there are no issues with the U.S. FDA or other regulatory bodies. For a clinical trial that will cost a minimum of $15 million, most sponsors find it’s worth spending 10-15% more with a reliable CDMO.
To the best of our ability we provide accurate, informed estimates, and we do not bill by the project. If the project takes less time than anticipated, we bill only for the time spent in the lab and/or manufacturing suite, and you save. Knowing the project will be done right-first-time, and efficiently is very inexpensive insurance.
When sponsors come to us and say they received a lower bid, we surprise them by telling them to go with the other company if cost is that important to them. When factoring in our stellar track record with the FDA and other regulatory bodies, the vast majority go with us.
Flexibility to adjust schedule for special requests
Time is always of the essence in drug development. We have sponsors coming to us all the time with requests to give their projects priority, and their reasons are sound. For example, one customer learned that a major pharmaceutical company was going to put a competing drug into the clinic. They needed to move their timetable up by three months in order to publish data about their drug, which they believed was better.
Another customer was in fundraising mode and had to meet certain milestones or risk their funding, which would have been detrimental to both of us.
Whenever we can accommodate such requests, we try. If all it requires is extra human effort ,that’s not a problem, since being as flexible as we can be is part of our culture. We can add extra shifts and think out of the box as we always do—and I will humbly and proudly say, we do it better than anyone else in the industry.
Although we can’t make two products in the same piece of equipment at the same time, we do have options. We can slightly delay projects that are not as time critical if possible, and with the full consent of those sponsors whose projects can wait, knowing we would do the same for them when circumstances warrant.
As well, as part of Seqens CDMO, we have added capacity and can seamlessly transfer manufacturing to another plant.
Rapid decision making a major factor in flexibility
We are always busy with commercial projects, routine production and preparing product for the clinic. The single most important factor in our ability to be more flexible than most other CDMOs is our daily morning meeting. Every single morning, we have a call to discuss each project in progress. If we receive an urgent request for prioritization, we determine whether any work on an early phase project can be done in a non-GMP lab. Or, if a project manager tells us a project is delayed while waiting for a raw material or other reason, we see if we can reprioritize, pushing that project off for a few days.
It takes a great deal of hands-on management time to evaluate and accommodate such requests, but that’s what it takes to be flexible. It’s well worth the effort.
Owning our own facilities is just one extra assurance that Life Science Leader and ISI factored in when giving Seqens North America a top Leadership Award for Reliability. Other reasons we were chosen include financial strength and stability, and flexibility in adjusting our schedule to accommodate special requests. The great deal of hands-on management time and our culture of putting in extra effort when sponsors need us to are well worth the effort for all concerned.
We take a lot of pridein winning awards but prizes are secondary to what counts. We put a lot of thought into what we need to provide our sponsors because our goal is to have successful projects and happy clients who return to us the next time they have a project. The awards are icing on the cake for a job well done. We’d be happy to talk with you about how we can develop a project for you; please call us at (978) 462-5555.