CDMOs are problem solvers. They spend their days and nights developing and manufacturing new chemical entities (NCEs). This chemistry, always novel and never before tried, often presents problems that need to be resolved before initiating the next chemical step. Although experience and expertise are of great help in problem solving, one never knows with certainty how the chemistry will behave from one step to the next. As the need to scale up to larger quantities of material arises, it doesn’t necessarily follow that the chemistry developed when working with small quantities will be problem-free when preparing GMP material or larger quantities for late-stage clinical trials The scale up process sometimes unearths new impurities or temperature sensitivity or a myriad of other issues that require processes to be tweaked.
A fully integrated CDMO brings a wealth of experience and problem solving to such issues when they arise throughout the entire API project, from lab to scale up to manufacturing. There are at least four good reasons for sponsors to choose an integrated CDMO:
- It’s the surest way to adhere to timelines, as it eliminates the considerable time spent in technology transfer from one organization to another.
- Although the billing rate at an integrated CDMO may be somewhat higher to reflect investments in plant and equipment, the total project cost will most likely be lower, since processes will not need to be validated again and again every time a new organization works on the project.
- A CDMO experienced in both API development and manufacturing can often anticipate and circumvent potential issues, saving time and money.
- There is no lag time in sourcing quality raw materials and intermediates for the project.
Case example #1 – lessons learned
A West Coast pharmaceutical company that, in all fairness did not know about Seqens CDMO North America, began their API project at two small specialist CROs. However, those labs did not have GMP capabilities and when the project advanced to clinical trials, the customer was referred to us. The sponsor had already spent a fair amount of money on process chemistry and analyticals. However, due to the specialists’ limitations, we had to start over in order to take the project to the next level, resulting in unnecessary costs. In addition, the technology transfer caused delays that could have been avoided.
In the course of our initial, productive conversations, it became clear to the sponsor that at the end of the day, they had spent more than it would have cost to do everything the right way for eventual regulatory approval from the start. In another conversation the customer had, a colleague of theirs unknown to us said Seqens was the gold standard for API development and manufacturing in North America, giving the client further validation of the value of working with an integrated CDMO. [We were of course pleased–and humbled by that comment.]
Lesson learned: if your project is best served by going to an integrated CDMO, that’s what you should do. Realize that the hourly rate may be higher, but in the long run the efficiency of working with an integrated CDMO as opposed to working with various vendors can make all the difference in meeting timelines and staying on budget.
Case example #2 – are costs really higher at an integrated CDMO?
Years ago, the head of outsourcing for a major pharmaceutical company’s spinoff came to us. When reviewing our pricing, he balked. The company had been working with a smaller, 40-person shop that does small-scale process research. The smaller CRO did not have GMP capabilities, nor did they have a scale up process. Because their overhead costs were lower, they were able to charge 25% less than we could. However, they could not do what Seqens could—seamlessly take the client all the way from the lab to commercial manufacturing.
By moving to an integrated CDMO, the company received greater value as follows:
- Access to invaluable cross-departmental expertise from a much larger pool of highly experienced scientists.
- GMP capabilities.
- Scale up capabilities.
- Quality assurance.
- Regulatory expertise.
- Project management expertise, an important and often overlooked differentiator.
- Access to the more sophisticated equipment needed for later-stage projects.
- A CDMO’s ability to handle multiple API projects well, without delays.
That conversation took place six years ago. We have been working with the company ever since and have developed every one of their molecules. Price has never again come up.
Why Seqens business close rate is 4x higher than the industry
Our close rate for winning business is four times higher than the industry average of 15%, and in the case of business referred to us, more than 90%. We believe there are reasons for those above average numbers that go beyond value, quality, expertise and equipment.
We have always been proponents of open and transparent communication – and a great deal of it. From initial conversations about how we set our rates and the value we provide, to all the day-to-day collaboration with sponsors that is our hallmark, sponsors who work with us know that ultimately we have their best interests at heart and will work tirelessly to do everything within our power to assure their projects meet their timelines, milestones or funding deadlines.
We have worked hard over the last decades to build our strong reputation, and we intend to prove every day to each and every customer—and to the many who refer them to us–that they chose well.
We have written a lot about ways to cut costs and save time while working with a CDMO. Please check out other articles on our blog or call us at (978) 462- 5555 to learn more.