People are more aware than ever of the many amazing ways new treatments can improve their lives. As a result, life sciences companies are under more pressure than ever to safely deliver new, innovative treatments to market to satisfy customer demand. The key to accelerating that pipeline is based around four pillars of digitalization that Emerson experts Michalle Adkins and Karen Fung share in a recent Q&A in BioPharma APAC. Understanding those pillars, they explain, help get treatments to market more quickly and make it easier to maintain a reliable supply.
Pillar One: Pipeline Acceleration
A critical strategy to shortening the time to release of innovative new treatments is shortening the steps between research and development and full-scale manufacturing. One of the key strategies teams can use to accelerate the manufacturing pipeline is implementing fit-for-purpose software designed to standardize and streamline every stage of development. Michalle explains,
“Tools like Process and Knowledge Management software are critical to standardizing process steps along with the associated critical parameters and attributes to shorten the technology transfer process and quickly bring new products to market. PKM’s facility fit feature quickly compares existing facilities to see which equipment set has the necessary capabilities at the right scale to manufacture.”
Pillar Two: Flexible Manufacturing
Many treatment manufacturers have moved away from the single blockbuster drug model of manufacturing. Today, the most innovative, and often most successful organizations are opting for smaller, more custom treatments targeted at specific populations. Accomplishing this paradigm shift in manufacturing requires operations teams to be more flexible—the ability to change equipment, materials, and processes quickly and efficiently is paramount.
Pillar Three: Operational Integrity
If a plant isn’t running, it isn’t producing. And if the plant isn’t producing, its customers are lacking the treatments they need. The best way to avoid disruptions is to predict and plan for problems before they occur. As Michalle and Karen detail,
“Predictive maintenance technologies, often supported by artificial intelligence and machine learning, are key to catching problems before they impact operations.”
When information is siloed in different, potentially proprietary systems, speed to market is difficult to improve.
Pillar Four: Real-Time Release
The goal of accelerating the production pipeline is real-time release—as soon as a product is complete it is ready to go to market. Accomplishing this goal requires digitalization of the manufacturing process. Technologies like electronic workflow, electronic batch records, and quality review manager software can be used together to identify, review, and resolve exceptions as part of the process before batch completion, enabling release by exception. And new solutions like Process Analytic Technology even bring testing in-line with the process, minimizing the testing steps necessary after batch completion.
Digging Deeper into Digitalization
Karen and Michalle delve into many other ways digitalization is transforming the life sciences manufacturing landscape. Streamlined human machine interfaces, automated import of configuration, near plug and play connectivity of equipment, and more are all being made possible by technologies such as the DeltaV PK Controller, DeltaV Live, and Syncade manufacturing execution system.
To learn more about the ways digitalization is changing the biopharma landscape, you can read the Q&A in full over at BioPharma APAC. And while you’re here, take a moment to share your thoughts on the exciting changes coming in the life sciences industry. I’d love to hear how they are impacting your operations. Feel free to comment below!
The post Four Pillars of Life Sciences Speed to Market appeared first on the Emerson Automation Experts blog.
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