There are three main reasons sponsors choose a CDMO for development and manufacturing of their API, nutraceuticals or specialized chemistry projects.
- The most important is high quality work pharmaceutical companies can rely on.
- The deep knowledge and problem-solving capabilities emanating from experience with a broad range of development and manufacturing projects.
- On-time project completion, which will be the focus of this article.
There is, of course, much more that’s important to sponsors in choosing a CDMO, including manufacturing capabilities, project management skills, appropriate equipment, excellent analytical capabilities and others. The best CDMO for your project is the one with relevant experience and appropriate equipment. The CDMO should be right-sized for the job at hand and have a solid track record with regulatory filings.
Sponsors appreciate our 96% on-time delivery
From 2009-2019 we achieved a 96% on-time orders delivery. While we have not benchmarked against others, there is little doubt this is an accomplishment we can be proud of and one that is appreciated by our customers, who know they can rely on us to work 24/7 if that’s what it takes to meet their deadlines. Whether it’s a clinical trial, first-to-market strategy or funding tranche at stake, what’s critical to our sponsors is important to us.
Five steps to achieving high on-time delivery of APIs
- Set up a schedule at the beginning of a project – and control it closely
We control projects very tightly, or at least everything that is within our control. That includes resources, equipment, and Quality Control support among other factors that need to be managed to keep a project moving toward completion. This is something we focus a lot of time and effort on.
- Anticipate things that are outside of your control
There are times when raw materials suppliers let us down by not delivering, delivering late or delivering materials that do not meet our quality standards. To assure we have what we need when we need it, we do four things:
- We vet our suppliers carefully.
- We develop close relationships with them.
- We have backup plans to secure redundancy where possible.
- We are not swayed by price alone when sourcing raw materials, which would be penny wise and pound foolish. Quality and reliability are as important.
- Be prepared to problem solve
Many years ago, we thought we had all the raw materials in place for an early stage non GMP intermediate we were starting. The first chemistry steps were carefully planned, and we were ready to go. But we discovered we had magnesium sulphate anhydrous when what we needed was 50 kgs of magnesium sulfate heptahydrate. It would have taken several days to get our supply, delaying the project. What we needed was essentially Epsom Salt, sold in every pharmacy. So we gave every person on our staff $50.00 and sent them out to all the drug stores and supermarkets in the area to buy all the Epsom Salt on the shelves. Our people were leaving the store with shopping carts filled with Epsom Salt. We quickly obtained enough supply to make our first batch, averting a delay. When a problem comes up ask yourself and your staff, what are the alternatives?
- Have a daily meeting
Big problems and small problems are daily occurrences at a CMO. To keep projects on track we have a daily meeting to anticipate or resolve any issues that could arise. We do not leave the room until the entire team knows exactly what each individual needs to do. Our focus on frequent communication assures that senior management is always available, 24/7, to make rapid decisions.
- Manage risk diligently
Long ago we implemented Quality Risk Management (QRM) as an essential element in every aspect of our drug substance development and manufacturing. QRM extends throughout the product’s entire life cycle—from pre-clinical to Phase I trials and through Phases II, III and commercialization.
We also adhere to Quality by Design (QbD) principles to ensure that all sources of variability affecting a process are identified, explained and managed appropriately. This “right first time” focus assures not only high quality, but also smooth API development, with the understanding that “smooth” is aspirational when developing new chemistry that often surprises.
But that’s not all we do to manage risk. In some of our programs we have two teams working on projects simultaneously. If one succeeds and another fails, our sponsors still have their materials. By perpetually managing for risk, daily deciding such things as the number of batches to make and developing contingency plans should a process be less than optimal, we do everything within our control to bring projects to completion.
We know our clients have important milestones to meet. In addition to industry best practices, we have developed our own best practices—and they work well enough to have achieved a sustained 96% percent on-time delivery for a decade.