thought leadership

Embracing Pharma 4.0: How L7|ESP® is Transforming Data Contextualization and Workflow Management for CDMOs

by Steven Barash | posted on June 20, 2024

In the dynamic pharmaceutical industry landscape, Contract Development and Manufacturing Organizations (CDMOs) are increasingly adopting Pharma 4.0 principles to enhance their operations and deliver greater value to their customers. A recent article in Contract Pharma highlights the imperative for CDMOs to digitalize their processes, emphasizing the crucial role of advanced data management and workflow automation. At L7 Informatics, we are at the forefront of this digital transformation with our innovative L7|ESP® platform, designed to revolutionize data contextualization and workflow management.


The Challenge: Navigating Complex Data Environments

As CDMOs strive to meet the growing demands of the biopharmaceutical market, they face the challenges of increased timelines for successful tech transfer, paper-based operations, increased batch disposition timelines, insufficient data integrity controls, and resource demand for manual-based operations. Their customers, in turn, expect reduced fees based on increased capacity among their competitors. We need to address these challenges now, especially as traditional data management systems lack the necessary integration and context, leading to inefficiencies and potential compliance risks.


L7|ESP: A Unified Digital Platform with a Suite of Business Apps

L7 Informatics has developed the L7|ESP platform to address the critical challenges faced by CDMOs, particularly those relying on paper-based operations for manufacturing and testing. These manual processes delay batch disposition timelines and ultimately impact the bottom line. L7|ESP offers an integrated solution that combines Manufacturing Execution Systems (L7 MES), Laboratory Information Management Systems (L7 LIMS), and the L7 Scheduling applications. This unified approach automates workflows, reduces human error, and integrates seamlessly with instruments, significantly mitigating data integrity risks. By transitioning to this digital platform, CDMOs can streamline operations, enhance product quality, and accelerate revenue recognition, transforming their manufacturing and testing processes for better efficiency and reliability.


Streamlining Workflows with Automation

In addition to data contextualization, L7|ESP offers robust workflow management capabilities. The platform enables CDMOs to automate development, manufacturing, and testing workflows, reducing manual intervention and minimizing the risk of human error. This automation extends across various processes, including sample management, quality control, and batch disposition.

By automating these workflows, L7|ESP enhances the overall operational efficiency. CDMOs can achieve greater consistency and quality in their manufacturing processes, ultimately delivering better outcomes for their customers.


Enhancing Customer Value Through Digitalization

CDMOs’ digitalization journey is not just about technology adoption; it’s about transforming their entire approach to drug development and manufacturing. L7|ESP plays a pivotal role in this transformation by providing a scalable and flexible platform that adapts to CDMOs’ evolving needs.

With L7|ESP, CDMOs can leverage advanced analytics and machine learning to gain deeper insights into their operations. These insights enable proactive decision-making, predictive maintenance, and continuous improvement, driving operational excellence and enhancing customer value.


Real-World Impact: Success Stories

Several leading CDMOs have already realized the benefits of implementing L7|ESP. For example, a prominent CDMO leveraged the platform to streamline its data management processes, resulting in a 30% reduction in data handling time and a significant improvement in data accuracy. Another CDMO used L7| ESP’s workflow automation capabilities to enhance batch record management, achieving a 25% increase in production efficiency.


Looking Ahead: The Future of Pharma 4.0

As the pharmaceutical industry continues to evolve, adopting Pharma 4.0 principles will become increasingly critical for CDMOs. L7 Informatics is committed to supporting this evolution with our cutting-edge L7|ESP platform. By providing advanced data contextualization and workflow management solutions, we are helping CDMOs navigate the complexities of the digital age and deliver superior value to their customers.

In conclusion, the digital transformation of CDMOs is a journey that requires innovative solutions and a forward-thinking approach. L7|ESP is not just a tool; it’s a catalyst for change, empowering CDMOs to achieve their digitalization goals and thrive in the competitive pharmaceutical landscape.


Steven Barash, Vice President of Strategy & Development

Steven Barash is a dynamic manufacturing information systems thought leader spearheading digital manufacturing initiatives at L7 Informatics. Steven holds an established software implementation portfolio of regulated technology solutions in the cell and gene therapy manufacturing industry. Steven is committed to end-to-end automation of complex cell gene manufacturing operations to deliver personalized treatments to patients. He is focused on delivering unified enterprise data solutions to ease operational complexities, improve product quality, and digitally scale GMP commercial operations. Before L7 Informatics, Steven held various leadership and engineering roles at Charles River Labs, Cognate BioServices, TRC, Juno Therapeutics, Regeneron Pharmaceuticals, and AxoGen. Steven has a B.S. in Chemical Engineering from the University of Florida where he focused on translational research in immunomodulatory drug efficacy in preclinical animal models.