There are three main reasons sponsors choose a CDMO for development
and manufacturing of their API, nutraceuticals or specialized chemistry
- 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.
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.
appreciate our 96% on-time delivery
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.
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.
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.
About the Author
Ed is President & CEO of SEQENS North America (formerly PCI Synthesis). He serves as a co-chair of the New England CRO/CMO Council and sits on the Industrial Advisory Board for the Department of Chemical Engineering at UMass, Amherst. Ed is also a long standing member of the American Chemical Society and advises the Bulk Pharmaceutical Task Force of the Society of Chemical Manufacturer’s and Affiliates (SOCMA)...
Do you have questions? Talk to Ed.