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Three good reasons why an Embedded CDMO model offers the best route to commercial success

By Tom Wilson October 2019, General CDMO

Although commercialization routes for drugs and therapeutic compounds are relatively well mapped, the drug development and manufacturing process will always require experienced navigation skills to anticipate challenges. It takes expertise to keep projects on course to target markets. That’s why the outsourcing of drug product development and manufacturing with contract suppliers has become the preferred go-to-market strategy by many of the industry’s leading drug developers and intellectual property (IP) owners.

As demand for strategic outsourcing grows more powerful, so have the offerings of contract development and manufacturing organizations (CDMOs). Some of pharma’s top legacy brands also took notice of the market’s potential and developed their own innovative response.

What emerged is a distinct class of contract development and manufacturing services suppliers (similar to contemporary end-to-end CDMOs) but embedded in big pharma.

Powerful parents, compelling strategic partners

An embedded CDMO operates as a self-contained enterprise but exists within a larger pharmaceutical company. These pharma leaders have coped with shifting markets, patent expiries and all the ups and downs of making pharmaceuticals for decades. This means that embedded CDMOs have access to the sites, resources and expertise of the parent.

Access to the expert capabilities of pharma’s embedded CDMOs is offering great economies and competitive experience, but those attributes can also be offered by pure-play CDMOs. However, an embedded CDMO can offer more. Inherent to their core strengths, here are three good reasons why an embedded CDMO can offer the best route to commercial success.

Number one: Regulatory experience, quality systems expertise

Pharmaceutical companies and the industry in general, must be particularly adept at meeting regulators’ expectations. The best strategic partners understand the impact of regulations and can navigate a complex, global landscape of requirements. This is particularly important when products are intended for prospective new, or global markets where regulatory experience can offer competitive advantage and the agility to help speed most drug commercialization plans.

Deeper understanding, deeper value

By possessing a deeper understanding of the regulations that apply to each step of the development and manufacturing journey, embedded CDMOs can often anticipate questions and issues that might arise and help avoid costly delays.

For example, experience shows that if Chemistry, Manufacturing, and Controls (CMC) filings are too prescriptive and defined, the documentation can severely limit future flexibility and the ability to respond to unforeseen circumstances when they crop up. If filings are over-detailed, everything is locked up from the start. Any deviation after filing can only be made by amending the NDA—an expensive and timeline-destroying undertaking.

It takes a nuanced and knowledgeable approach to do this well. With legacies of successful (and perhaps not-so successful) campaigns and commercial manufacturing experience behind them, embedded CDMOs may be able to offer best-practice regulatory support and better “future-proof” strategies for CMC filings and all regulatory affairs.

Good practice (GxP) requirements are constantly in flux and they can vary from location to location, country to country. Compliance efforts are open to interpretation by manufacturers as well. Pharma companies and their CDMOs need to remain up-to-date with any challenges and changes they may face and invest accordingly. Embedded CDMOs often lead this commitment to continuous improvement because the company has institutionalized this strategy to improve operational excellence.

In many cases, drug manufacturers must develop their own strategies and operational methodologies to demonstrate compliance. An embedded CDMO’s decades of experience on a global stage can offer distinct competitive advantage in this area.

Number two: Access to world class science, chemistry and people

Working with an embedded CDMO gives customers access to the same people and advanced science that are used by the parent to bring new innovations to market. The most effective programs are managed by careful and intelligent collaboration with specialized teams.

Embedded CDMO teams are able to bring smarter approaches to drug substance and drug product commercial manufacturing including:

  • Instituting optimal scale up strategies
  • Innovating better, more efficient synthesis and cleaner chemistry methods
  • Mitigating process variability and understanding process stability issues
  • Achieving raw material economies

Number three: World class operations and sustained investment

An embedded CDMO’s strategic value is also contingent on the quality of its facilities, and a devotion to technical innovation. Nothing demonstrates the performance capabilities and health of an organization like a track record of sustained investment to improve operations.

It is important to note that, while other CDMOs may base new technology investments simply on keeping up with market trends, embedded CDMOs have built up specialist expertise and invested in the appropriate technology over time. This in turn means they have built up the right expertise and are therefore well positioned to reduce risk when delivering customer projects.

In short, quality, reliability and commercialization success are subordinate to the time, money and resources contract suppliers invest in their people and facilities.

Going into the next decade, it is likely that more companies will embrace the embedded model as a strong option to bring their drug to market. However, these and other performance attributes can only emerge with effective collaboration, with teams organized and experienced enough to deliver the kind of personalized, professional services that sustain better drug commercialization for the long run.