Digital Evolution: A Critical Next Step for CDMOs

Executive Summary

CDMOs need to become technology leaders. Changing market dynamics, an industry push toward innovation, and customer requests for greater transparency are creating the "perfect storm." To prepare for the storm, CDMOs must move towards modern digital solutions.  The concern around digitalization previously felt by CDMOs can be all but erased by using modern solutions with proven teams to mitigate the burden of change management.  Adopting new technology shouldn’t be viewed as a way to simply brave the storm but rather a lighthouse to guide CDMOs to a new horizon. 

“It is not only important for CDMOs to be trusted partners for mature pharmaceuticals, but it is also essential for them to contribute specialty technical knowledge to maintain a competitive capability edge in manufacturing innovative products”

Dr. Isabelle Heiber, Partner, Strategy and Transactions, EY-Parthenon GmbH

Paper Stifles Customer Collaboration

Customers crave reliable and consistent real-time information from their CDMOs on product quality, batch status, and successfully-released product. Paper processes can take weeks or even months to provide customers with the relevant data, creating delays and a sub-optimal experience.

Digital platforms, like Tempo, offer a short time-to-value with streamlined validation and rapid deployment approaches. Tempo provides the visibility needed to collaborate with customers to keep them informed and happy, while simultaneously enabling CMDOs to flex with manufacturing capacity needs and adjust for production requirements. A digital solution needs to serve the CDMO both as an end user and as a provider to their customers, anything else is not allowing the full realization of going digital.

Digital for the Competitive Edge

Imagine being able to manufacture your first batch digitally in 4 short months and increase net margins by 4% after deploying a digital MES. The forward-thinking CDMO knows that a digital MES platform is the secret to gaining a competitive advantage. Digital systems not only enhance leadership positioning, but also enable global competitiveness. 

Cloud-based solutions can reduce labor costs, non-labor resources, and accelerate batch release times, ultimately allowing organizations to get customer products to market faster so they can be sold sooner. With low resource allocation, and faster data-sharing, even organizations with smaller margins can improve financial performance by going digital.

Transitioning from paper to digital won’t interrupt your day job, either. Good MES Vendors will take on the burden of set up, streamline onboarding so that it’s fast and simple, and provide 24/7 support. The ongoing health of your digital system becomes a vendor-managed responsibility, keeping the pressure off your resources.

For hesitant CDMOs looking for metrics before they commit to a digital system we recommend starting with a POC, which can serve up actual product insights and ROI. POCs are not resource intensive and can prove explicit value over a 6-8 week run.

De-risking Change Management 

Behind every smooth paper-to-digital transition is a comprehensive project plan outlined with clearly defined goals, timelines and resource expectations. It should map the digitization process, outline stakeholder participation, and provide timelines for onboarding, configuration, and validation processes. This enables CDMOs to manage resources accordingly throughout the transition and eliminate the burden on leadership teams responsible for focusing on day-to-day operations.

What we recommend:

• A fast, risk-based CSA validation approach 
• Early discussions to prepare customers for your transition
• Templatized documents to get you started
• Start small and grow for maximum adoption and planning

Conclusion

Today’s industry environment and trends create a unique opportunity for CDMOs to better meet business goals. Technology is enabling organizations to accelerate production and provide a much improved customer experience, both of which increase overall global competitiveness. By setting clear expectations and deliverables early on with their digital vendor, organizations can streamline their digital transformation and strategically advance beyond paper-based processes.

Looking to go digital and achieve focused initiatives using agile software that can deliver benefits without large capital investments? Connect with our team and learn more about our Tempo Manufacturing Cloud.