From Molecule Discovery to Commercialization: Why it’s Good to Have One CDMO for the Entire Journey

New breadth of capabilities

Posted: August 24, 2018

API Manufacturing and Pharmaceutical Manufacturing

Now that PCI Synthesis has been acquired by Novacap, a global player in pharmaceutical synthesis, we have access to phenomenal resources around the world. We can easily tap the technical expertise, facilities and knowledge of a combined team consisting of 12 cGMP sites, two main R&D centers, and a large range of services and technologies for clinical development and commercial manufacturing.

Being part of this new talented team reminds me just how valuable it is when one company can provide the full continuum of services –from the preclinical discovery phases of product development to scale-up and product commercialization, and everything in between.

So why is it important to have this continuum of support from a single CDMO? Consider the following:

Time and Costs

The time it takes to go from discovery to commercialization of an API or NCE is a long one – taking more than a decade in some cases. When you think of all the stages – from process research, process development, analytical development, process validation, small scale and large scale manufacturing, regulatory support, and FDA filing – there’s a lot of moving parts.  There’s also a lot of lessons learned, knowledge gained and collaboration that must take place. When these different stages are outsourced to a variety of firms the accumulated information and chemistry needs to be transferred. This “passing of the torch” takes time and, in addition to slowing down any momentum that may be moving your project along, it costs additional money, since each CDMO needs to be paid for this knowledge and process sharing.

On the other hand, sometimes smaller sponsors, who may not be interested in long-term investment, and seeing a product through to commercialization, and who may only be interested in taking a molecule and flipping it to another firm, can get by using a smaller CDMO. After all, it’s a cheaper way to get a specific phase done and then move away from the project.  But those firms who are in it for the long haul, less time and costs are required when you use a single CDMO.

Chemistry Doesn’t Just Happen in the Lab

Since collaboration is essential to every project,  the various scientists, project managers, QA professionals and others build a strong rapport that helps them understand all past elements of the project, and collaborate to solve problems internally.  This, combined with a shared corporate commitment to excellence and other corporate goals, results in seamless projects with consistent quality across the various phases.
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Single Source of Accountability

There’s no getting around the fact that molecules can be complex with no way of predicting when something is going to go wrong. Work done during the analytical development phases could have a major impact on what happens down the line, and what happens in the Kilo lab could have repercussions in large-scale manufacturing – or even post commercialization. When things do go wrong it’s good to have a single CDMO to turn to which has visibility across the entire lifecycle of chemical development.

Breadth of Capabilities

From our perspective at PCI Synthesis, in addition to the seamless experience for customers, being part of a larger organization provides huge benefits in terms of much larger scale capabilities.  Below are three key benefits:

  1. Larger manufacturing capacity. In our Newburyport plant, we have had the capacity for the manufacture of 10-20 metric tons of specific drug substances, yet with our European counterparts we have capacity for much larger volumes of manufactured products for those clients who require much broader dissemination.
  2. Huge knowledge base. We now have access to all the chemistry that has been created in 35 industrial plants, R&D units and offices, and by more than 3,000 employees over the past 30 years. This kind of experience and knowledge and wealth of data takes years and years to amass, yet we now have access to it immediately.
  3. New offerings. With Novacap’s breadth of offerings, our customers now have access to services, such as solid state chemistry, which is the study of the synthesis, structure, and properties of solid phase materials which is becoming an increasingly important component of the drug development process. This and other disciplines expand the types of services we can provide clients, now and into the future.

The road to drug development is fraught with tons of complexity, costs and time.  The capabilities of a combined Novacap shows us just how efficient the journey can be when its centralized under one CDMO, providing a seamless and consistent experience built upon a common, shared commitment to quality.

About the Author

Ed Price CEO of PCI Synthesis
Ed is the President and CEO of PCI Synthesis (PCI), 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.