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The three key ingredients to a successful API project

By Tom Wilson November 2019, Custom API

What’s the recipe for API project success? As established pharmaceutical companies continue to reduce manufacturing footprints to match their capital plans and small- to mid-size innovators pursue faster go-to-market models via virtual company routes, outsourcing managers are seeking better alliances and smarter collaborations from their current and future suppliers.

A drug’s commercial development and speed to market all hinge on creating effective working relationships with contract API suppliers. Finding and selecting the best CDMO to develop and manufacture your API and collaborate with you on your drug’s development and commercialization journey is central to the effort. To help assure your next custom API project is successful, see that your “cooks” are integrating the following three key ingredients into their recipe: Flexibility, customer commitment and collaboration. 

Key ingredient #1: Flexibility—You’ll know it when you need it

Industry polling reveals CDMOs that deliver attributes like quality, reliability, productivity and regulatory vision are what sustain successful strategic API supplier relationships.* And though it’s true that regulatory wisdom, global presence and quality are on most everyone’s list, flexibility should be on the list too, and right there at the top.

Flexibility might in fact be considered the “secret” ingredient to successful API project outcomes. Contract manufacturing and API procurement managers are beginning to consider it a key attribute of the contractors they select for their projects.** However, “flexibility” can manifest itself in a variety of ways and is relative to each individual drug in development.

Relative to API development and manufacturing, suppliers’ technical acumen, capacity and operational resources must be flexible in the sense that they can respond appropriately to meet the known and unknown changes and challenges that arise during most API projects.

Flexibility helps avoid risk

Flexible, smart API contractors know how to manage risk from beginning to end, then integrate that into all aspects of planning and collaboration to secure new project success. Suppliers that can demonstrate that they are agile with contingencies are the kind of smart collaborator you need.

The ability and experience to predict and identify potential project risks ahead of time, as well as ways to mitigate any poor, but plausible outcomes, are signs of API supplier flexibility. When your contract manufacturer can respond to potential change and anticipate the possibilities of rising or receding demand, for example, supply chain disruptions or other processing issues will always be handled in a way that sustains product strategy rather than defeat it.

Product quality and reliability of business-critical supplies are tightly linked; the more expertise and experience your contract and supply partners have manufacturing high-quality, compliant products, the more likely it will be able to assure continued reliable delivery of APIs.

Key ingredient #2: Customer commitment – Unfailing dedication required

Another predictor of an API project’s success is understanding how your suppliers demonstrate their commitment to customers. Regardless of what your drug’s market agenda might be, it is likely plans call for some fairly long commitments by all parties involved. Certainly, API supply and development relationships sealed by contracts are legally committed—but a strategic contractor has to demonstrate value beyond contractual terms.

As mentioned earlier, mitigating supply chain risk is a primary concern but it has to be achieved economically; contract manufacturers that provide unwavering product quality, deliver on time and in full, are by definition strategic and committed to their customers. There’s an old rule of thumb around Pfizer CentreOne: “The most expensive batch of API you will ever pay for is the one you can’t use or sell.”

Customer commitment can also be measured by the time, money and resources a contract manufacturer consistently invests in its people and facilities. Partners with both eyes focused squarely on operational excellence and its people will remain the kind of API partners a smart sourcing collaboration can be built upon.

Customer commitment is predicated on the demonstrated performance and health of the organization, financially and operationally. Aligning with suppliers not committed to developing their own organizations might not be the best way to go.

Key ingredient #3: Collaboration – It must be intelligent and productive

CDMOs with experience and vision will likely be able to bring to the relationship an intelligent, collaborative approach and the insight needed to innovate solutions. Part of this comes from the talent and resourcefulness of the people the company hires, and the way they “deploy” this talent to meet customers’ expectations.

This extends to the abilities of these people to leverage all resources and technologies at hand to assure the best outcomes. These attributes support creating an environment that is responsive, agile and more capable of performing over the course of the project.

Whatever your product’s market agenda might be, drug owner and drug maker often have to build a common base of knowledge and do it in a timely, prescribed manner. Better drugs begin with a better, smarter collaboration and the sooner both parties can achieve a true and transparent meeting of the minds, the better off any API project will be.

*https://www.pharmasalmanac.com/articles/the-cdmo-and-the-international-supply-chain

** https://www.pharmasalmanac.com/articles/meeting-the-need-for-small-volume-api-manufacturing