Digital Integration of Sponsor and Contract Organizations
Biomanufacturing sponsor organizations are increasingly operating with a network of contract organizations and partners to innovate and manufacture at speed and at scale. And one big challenge is digital ways of working between the companies. In every case, they do some physical work but increasingly it is the data that is really significant.
The Digital Integration of Sponsor and Contract Organizations (DISCO) program is a collaboration between leading biopharmaceutical manufacturers, contract organizations and IT solution providers, working together to bring about a shared vision of digital maturity in their operational ways of collaborative working. We meet fortnightly to work together on this industry challenge, focused on the data interactions for quality, supply chain, manufacturing and tech transfer.
Digital maturity varies and is mismatched in partnerships
Biomanufacturing sponsor organizations are increasingly operating more deeply with a network of contract organizations and partners to innovate and manufacture at speed and at scale. Vice versa, contract organizations receive multiple demands for visibility, flexibility and automation from sponsors which means collaborating digitally, and the requests are different every time.
It is common to work with a wide range of partners, all at different levels of digital maturity. Standards have not been established and adopted for this industry, so current integration solutions are not always robust, flexible, real-time or validated for GxP. It is really inefficient, limiting and unsustainable for the industry to have so many different and incompatible point solutions.
Standard approaches to climb the digital maturity ladder
Our vision is for an increasingly standard framework for digital integration with the flexibility to work with existing mismatches of digital maturity. By analogy, it is something like a bridge – capable of carrying all kinds of traffic, fast and slow, built once to serve many, robust and secure, and designed for longevity, a solution that lasts into the future.
We are starting to define the integration points where something better would make a real difference and bring benefits. We are setting out what data structures and standards should look like. Shared experiences and innovations on how we transport data while managing cybersecurity. Our focus is on the data interactions in the inter-linked areas of quality, supply chain, manufacturing and tech transfer.
We are working to bring that vision to life in three ways:
- Communicating it to the industry as a stake in the ground and a reference point for assessing the current state and formulating plans for the future
- Sponsors and contract organizations are sharing their own strategies for digital integration and working to align with each other and with the vision – which makes their plans more credible, sustainable and thorough, and creates the basis for industry-wide change
- Shared experiences are the basis for a playbook (currently in development) for establishing a digital partnership
Finally, we are pushing forward some of the key topics (such as Digital Certificates of Analysis and Digital Deviations), defining the design options and data structures, reviewing emerging standards (such as PQ/CMC) identifying where new standards are required, establishing the collaborative basis for those future standards, articulating benefits of change to all the stakeholders. This will accelerate analysis, design and build, and reduce risk.
All of which help us progress toward better integration between organizations, making more and better data available faster, creating visibility of work in progress, improving efficiency, reducing the opportunities for human error, speeding up batch release, creating the agility to integrate with new partners more easily and supporting advanced and personalized therapies.
Digital Integration of Sponsor and Contract Organizations deliverables
More related workstreams
Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.
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