There has always been a case for digital transformation in biopharma product development. The challenge comes in delivering it. An overreliance on paperwork combined with siloed systems that disconnect R&D from manufacturing make it hard for a biopharma company to manage the many processes that affect product lifecycle management. These challenges have regularly derailed product scale up and, ultimately, launch.
Industry regulations, quality and supply chain requirements only add to the hurdles. This is also before mentioning the people problem. How do you create a process and technology platform that sits comfortably with biochemists, chemical engineers and data scientists, or between an internal and external workforce?
Our answer is the Digital Thread for Life Sciences (DTLS), a powerful combination of product, process and quality data. It replaces paperwork with shared digital tools. DTLS can bridge R&D with manufacturing and the quality control labs when it comes to data and knowledge exchange. This lets companies reduce product scale up timelines while getting the most out of the current resources.
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Building the model in SAP
DTLS is designed to align with the core SAP data model to simplify the management of data and replaces legacy practices that need manual configuration.
Other features include a governance and workflow engine, the ability to have security-based rules and approvals and having better version control of product data. These all help achieve timely scale up of the product. For example, the “timeslider” feature shows the products timeline and processes as it moves from development to commercial manufacturing.
DTLS can integrate with core business systems such as Regulatory Management Information System (RIMS) and Quality Management System (QMS) to streamline lifecycle, regulatory and business changes to the product. The digital product profile produces analytics that support business intelligence initiatives.
Creating a collaborative culture
Having a digital thread also encourages a more collaborative culture. All stakeholders are able to refine the product and the process characteristics digitally, within a single system. It shortens investigations for manufacturing and quality professionals who may spend too much time collecting data and could benefit from more time to analyze the findings.
Moving to a digital-first strategy
This lets biopharma companies move towards a digital first strategy. By developing a platform-driven model to manage their products, DTLS can make companies more prepared for future innovation. Material and quality specifications are the starting point in what becomes a digital process – driving testing and informing product release decisions through quality control.
We refer to this as a “round trip”. Using DTLS to spread data down to local production and lab systems. Making it possible to coordinate processing information and laboratory data for thorough investigations. It’s one of many benefits of going digital.
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DTLS delivers operational efficiencies that come from bringing together New Science, IT and innovation – providing a template that scientists and engineers can adopt to communicate better and collaborate across internal and external ecosystems with easy access to data.
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An enterprise data model
A digital thread can drive more informed strategies, rooted in reliable data. It creates a more modern, digital experience in both the lab and manufacturing where knowledge is stored and improved upon. In a time of skills shortages, it will help attract and keep top talent.
This provides biopharma companies with the platform to accelerate time-to-market for life saving products and treatments.