Accelerating Drug Launches: How Digitalized Manufacturing Shortens Time-to-Market

The New Reality in Pharma

The pharmaceutical industry is experiencing unprecedented change. The rapid COVID-19 vaccine rollout demonstrated what is possible when urgency aligns with modern automation. That paradigm shift set the bar for innovation higher than it has ever been. Expectations for life sciences have been drastically altered among the public and throughout the industry.

Now that the industry sees what is possible, teams around the globe are reexamining the treatment development pipeline – exploring smaller batch, highly specialized medicines for patients and responding to increased need for biopharmaceuticals. But without the urgency of a public health crisis, the question many are asking is: How will companies achieve greater speed-to-market and flexible multi-product manufacturing to bring the next generation of treatments quickly and safely to the patients who need them?

 

Four Technologies Driving Change

At Emerson, we believe greater speed and flexibility can be safely achieved with the right development and deployment of technologies: scheduling software, real-time release testing, one-click technology transfer and autonomous plants. These technologies will accelerate the growth of digital biopharma plants, which will get new products to market faster, enable more flexible and multi-product manufacturing through quick changeover of products, and improve operational integrity through predictive maintenance solutions.

1.  Predictive Tools Drive Efficiency

As manufacturers begin to make different drugs faster, they need to be able to schedule production in a very efficient way. Scheduling software helps companies accurately predict future plant resource availability so they can operate with more flexibility and efficiency. Scheduling software provides a unified view of operations, maintenance, quality and corporate systems, helping validate manufacturing operations and accelerate the process of bringing therapies from clinical trials to full-scale manufacturing.

2.  Shortening Time to Market

Traditional manufacturing practices have served the biopharmaceutical industry well for years but in complex production scenarios, life sciences manufacturers can find themselves sitting on millions or even billions of dollars in work-in-progress inventory while waiting on quality test results. That waiting game not only extends the time patients must wait for critical treatments, but also dramatically shortens the time manufacturers can capitalize on patent protection to recover research and development costs.

New drugs can cost millions of dollars and take 12 or more months to produce. If a batch fails release testing, manufacturers face both significant financial loss and the time cost of remaking the batch. Real-time release testing (RTRT) prevents this by continuously monitoring critical process parameters – many of which lack traditional sensors – throughout production to ensure drugs are made to specification. Combined with inline monitoring capabilities, RTRT enables quality reviews during production, preventing costly inventory holds and protecting manufacturers' investments, while bringing new and existing treatments to patients faster.

3.  Digitalized Collaboration Accelerates Drug Production

A major roadblock for many life sciences companies is technology transfer – the translation of the process, workflows and drug recipes scientists understand to the language of manufacturing and automation used by the equipment and facilities that make the drug.

Although complex, accelerating this process is becoming more important with today’s variety of new drugs being made and the flexibility required by life sciences facilities to do more frequent changeovers.

To achieve this, we must digitalize the process developed to make the drug, including its recipes, workflows and scaling instructions. With the right technologies and culture in place, we can enable automation of the technology transfer process and subsequent updates in almost one click.

While one-click technology transfer has not yet been accomplished, at Emerson, we are working toward that goal by leveraging industry collaboration in tandem with technologies like process knowledge management (PKM) software PKM tools break down the data silos that create tech transfer delays and inhibit speed to market. By standardizing data, interfaces and usability across the entire production pipeline, PKM software makes it easier to evaluate sites against a master recipe, transfer master recipes with process details and push parameters to downstream systems.

Emerson’s work with leading pharma partners has shown that a fully automated technology transfer process can reduce time-to-market from 10 years to less than three years – a 70% improvement that directly accelerates patient access to life-saving therapies.

4.  Fully Automated Execution

Gone are the days when all measurement and maintenance in plants had to be handled manually. New technologies are enabling the development of self-aware, continuously adaptive, “autonomous” plants that can help optimize production and detect and prevent problems before they cause disruptions.

Automation technologies – simulation, predictive modeling, remote monitoring, artificial intelligence and machine learning – drive autonomous manufacturing. Process analytical technology (PAT) accelerates the shift toward fully automated execution.

When PAT is fully integrated, manufacturers gain three critical advantages: real-time monitoring and diagnostics, documented quality assurance, and predictive maintenance that prevents disruptions. This creates a self-healing, data-driven production environment.

In addition, digital twin technology is being used not only to model processes in a simulated environment, but also optimize dynamic control through real-time collaboration and virtual process validation. 

 

The Path Forward

New technologies like personalized medicine will open the doors to a wide range of new treatments and today’s automation technologies are key to putting them into the hands of patients as quickly and safely as possible. The necessary shift toward digitalization is happening fast – building a fully automated future where biopharma companies have greater speed-to-market and increased competitive advantage. As technologies develop and advance in the years to come, the life sciences industry will be able to have an even greater impact on humankind’s health and wellbeing.