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CDMO Whitepaper

How can CDMOs turn their challenges into opportunities with digitalization?

How can CDMOs turn their challenges into opportunities with digitalization?   

Pharma contract manufacturers face increasing demands for flexibility, transparency, faster time-to-market and advanced data management. With digitalization, many CDMOs can turn these challenges into opportunities and increase value for both themselves and their customers.

Contract development and manufacturing organizations (CDMOs) play a vital role the pharma ecosystem. They provide marketing authorization holders (MAHs) with both additional manufacturing capacity and access to specialized production modalities.

CDMOs frequently act as trusted partners that enable their customers to avoid risky investments, meet sudden demands or focus on their own strengths. But with the advent of pharma production 5.0, and rising customer expectations, CDMOs are facing a new set of challenges which impact and alter the relationship between MAHs and CDMOs.

Meet the challenges head on

In order to stay relevant and competitive, CDMOs constantly have to adjust their business models and acquire new tools and capabilities. In this respect, digitalization is both disruptive and a tool to gain a critical advantage.

At NNIT, we have identified three current challenges faced by CDMOs face and we provide inspiration on turning them into opportunities using digital solutions:

Challenge #1: Greater complexity and varying demands

CDMOs have to adapt to a diverse client base with varying product and quality demands. This requires increased flexibility to accommodate smaller batch sizes and specialized treatments, often within a tight schedule. The challenge is to manage multiple clients' confidential data while respecting their specific intellectual property. This makes it difficult to balance efforts and increases complexity.

The opportunity: Gain agility and flexibility with digitalization

Digital tools are available to make processes faster and more flexible at every level of the pharma value chain. This includes managing clinical trials, predicting changes to customer demands with data-driven forecasts and ensuring that the right equipment is available for production.

Challenge #2: Increased expectations of transparency

Motivated by a desire to improve their own supply-chain processes, MAHs are increasingly requesting access to process data directly from their CDMO partners, ideally in real time. This goes beyond the traditional batch records associated with the finished product, to include information needed to improve product yield, packaging and logistics planning.  

The opportunity: Share real-time production data

Digital solutions allow CDMOs to forge a closer and more value-adding relationship with their customers. Being able to share real-time data from production with customers is a major competitive advantage. With strong integrations and robust data standards, CDMOs can effectively insert themselves naturally into their customers’ supply chains, and thereby improve speed, streamline communication and reduce the risk of errors.

Challenge #3: Optimizing asset utilization

CDMOs require more specialized equipment than traditional pharma companies to cater to diverse client requirements, including laboratory equipment for testing. This necessitates maximizing production-asset utilization and minimizing changeover time on production lines to ensure equipment availability for specific orders, reduce production time, and maintain quality and compliance standards.

Opportunity: Improve production processes and productivity

With a robust data governance strategy and strong vertical and horizontal integrations between digital systems like ERP, MES, LIMS/LES and the factory floor, CDMOs have access to a treasure trove of data which can be used to optimize their production and increase productivity and efficiency. This includes being able to intervene faster when deviations in production parameters occur, and less need for manual interaction in the production process.

want to know more? download the Whitepaper: How digitalization can help CDMOs gain a competitive advantage

Pharma is part of NNIT’s DNA, and we have an extensive track record of working with global life sciences organizations across all areas of the pharma production life cycle and GxP landscape. We offer CDMOs advisory, consulting and technical services that complement your business strategy and all customer needs.

In this whitepaper, we provide an overview of how CDMOs and other contract organizations can use digital solutions to improve their business.

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