Digital Transformation for Clinical-Stage Biotechnology

Digital Trailblazer: Moderna

This clinical-stage biotechnology organization created a ‘digital native’ facility that refines traditional drug development techniques and introduces a much more efficient and acute manufacturing cycle.

The personalized cancer vaccines and investigational therapeutics made at Moderna’s new 200,000 square foot facility are unlike conventional drug products, which need a tailor-made facility supplied with large-scale bioreactors.

Moderna is advancing a potentially new class of medicines known as messenger RNA (mRNA), created to propel the body of a patient into the bioreactor.

This means that several investigational therapies can be made by the company within one manufacturing site, rotating with agility from one to the other and significantly decreasing the time to clinic.

From the beginning, the senior leaders understood that such a unique method would need an equally unique digital strategy.

Data would need to be extracted from their development, manufacturing, and research processes by integrated systems.

The informatics activities between the established facility, where the analytical development (AD) team carries out tasks, and the new fully digital manufacturing facility would need to be seamlessly integrated.

The goal would be a flat, constant exchange of data that they could extract for insights related to performance, assisting a large clinical pipeline and, in the end, a new era of hope for patients with difficult and unfulfilled requirements.

They achieved this by allowing themselves to experiment. The Moderna team started by pressure-testing their digital strategy with the AD team in their established facility.

They could explore the total capacity of LabVantage LIMS away from the high-pressure environment of Good Manufacturing Practices (GMPs). This helped them to understand valuable lessons and see opportunities for harmonization, which could be converted to the latest GMP space.

Staff were trained on the ‘WHY’. The leadership team aimed to display the importance of digital transformation, showing its importance rather than just talking about it.

They produced a system to set over 100 cross-system integrations in motion, precisely blueprinted to enable a constant flow of data from one end of the company to the other, and in reverse.

They demonstrated to employees what it meant to maintain concentration on their task at the bench, while one click would alert the laboratory to a new sample, download a result, or reorder a consumable.

Employees could understand why this change was required, and could advocate for it once they had experienced the change in job focus and productivity.

They launched an impeccable system of shared learning assisted by data integration.

More than 7,000 events are instantly tracked at Moderna’s latest facility. All of that data is used to enhance efficiency and quality inside of varied but interconnected functions.

A good example of this is the crossover between QC and AD. The LES is utilized in their LIMS to seamlessly transport techniques and data from one to the other. Both functional areas benefit from enhanced productivity and a decrease in redundant tasks as a result of this.

Digital tools were utilized to convert data into significant insights. Developing mRNA-based investigational techniques needs a high volume of complicated, individualized stability studies.

One example of how they used technology to their advantage is when the Moderna team employed their LIMS to produce data visualizations and specialized interfaces which were exclusively configured to assist this volume.

In this example and several others, Moderna’s new facility pioneered an agenda of interconnectedness, analytical exploration, and data transparency, while employing dynamic, best-in-class tools to achieve their vision.

Building a native digital manufacturing site has been one of the most fun and challenging projects of my career. What made the project fun was working with the bold, relentless, and collaborative people that made it all possible.

Roland Smith, Moderna’s Sr. Director of GxP Digital Systems

Gartner explained, “CIOs establishing leadership in innovation and strategic business change should develop a digital business transformation strategy that can map a course through external forces to produce a satisfying customer experience.

Starting with what’s impossible is counterproductive. But when it comes to effecting transformation, CIOs must realize their organization is not just transforming itself, but it’s also seeking to transform an environment it is operating in or is seeking to operate in. This means the organization will have to navigate through a system of systems – the combination of the motivations and the actions of the actors that are consistent with that environment.

Gartner, Digital Business Transformation Strategy Needs a Change of Perspective, Brian Prentice

Develop the Right Strategy

Certain companies may be tempted to change everything simultaneously, but this ‘all or nothing’ attitude is fraught with difficulties.

Technological challenges may arise, such as making sure that all new platforms and systems are integrated to work smoothly together.

Interpersonal difficulties may also come up, for example managing the transition alongside employees who may be resistant, scared, or uncertain of their role in this new reality.

Different organizations who are facing sweeping changes necessary for real transformation, do not know where to start, so they never start at all.

It is essential to discover a middle ground between strict goal-setting and a calm, incremental rollout plan. The first stage is to establish a range of exclusive business objectives, which will create the foundation for a smart and conscientious path forward.

To achieve this, executive teams must identify the following:

  • What does this digital transformation journey hope to achieve?
  • What processes, technologies, and people are not serving (or are under-serving) the company’s potential as an enterprise? How can those people be empowered, along with changing those processes, and introducing pioneering technologies in order to speed up growth?
  • Where can value be added? Where are opportunities seen to mine information for insights that will assist in removing redundancies, imitating successes, and excluding obstacles that decrease speed and innovation?

How LabVantage Helps to Sharpen Digital Strategies

The ‘nerve center’ of pioneering organizations is the laboratory.

They have enormous potential to lead an organization’s complete digital transformation strategy as the main artery for transporting ideas from concept to production.

They prove the benefits of process automation and optimization by employing the latest best-in-class technology.

LabVantage assists laboratories in doing just that. Its advisors collaborate with senior teams to produce effective implementation methods, founded on which laboratory functions are most suitable to transition first.

As an example, a high number of digital transformation strategies begin in the R&D laboratory, where IT can configure, learn, and test the latest LIMS technology in a more compact and controlled environment, then bring those learnings forward to the whole enterprise.

About LabVantage Solutions

LabVantage Solutions, Inc. is the leading global laboratory informatics provider. Our industry-leading LIMS and ELN solution and world-class services are the result of 35+ years of experience in laboratory informatics. LabVantage offers a comprehensive portfolio of products and services that enable companies to innovate faster in the R&D cycle, improve manufactured product quality, achieve accurate recordkeeping and comply with regulatory requirements.

LabVantage is a highly configurable, web-based LIMS/ELN that powers hundreds of laboratories globally, large and small. Built on a platform that is widely recognized as the best in the industry, LabVantage can support hundreds of concurrent users as well as interface with instruments and other enterprise systems. It is the best choice for industries ranging from pharmaceuticals and consumer goods to molecular diagnostics and bio banking. LabVantage domain experts advise customers on best practices and maximize their ROIs by optimizing LIMS implementation with a rapid and successful deployment.

Sponsored Content Policy: publishes articles and related content that may be derived from sources where we have existing commercial relationships, provided such content adds value to the core editorial ethos of News-Medical.Net which is to educate and inform site visitors interested in medical research, science, medical devices and treatments.

Last updated: Apr 5, 2023 at 7:56 AM


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