Today’s biopharmaceutical market accounts for as much as 25% of the total pharmaceutical market, with projections for rapid growth over the next 5 years. This significant growth can be attributed to the increasing acceptance of biopharmaceutical therapies due to their ability to effectively treat previously untreatable diseases. The recent global pandemic has also brought to light the importance of biologically produced therapies such as the fast-tracked COVID-19 vaccines.

In the biopharmaceutical industry, nearly every scientific innovation is facilitated by the collection and analysis of data. Technological advancements such as Next-Gen sequencing, precision medicine, digital imaging, DoE and dynamic modeling to support process development have vastly increased the complexity of data management. Bioinformatics, an interdisciplinary field of science that combines biological data with techniques for information storage, distribution, analysis and data modeling to improve our understanding of biological processes, has therefore emerged as a critical factor in the development of a cohesive informatics strategy for the biopharmaceutical laboratory.

Biopharmaceutical Life Cycle Management

In the fast-paced world of bioprocessing, outdated and legacy systems are not able to keep up with increasing demands and advancing technology. Digital connectivity across the entire process workflow is a necessity for keeping pace and remaining competitive in the industry. Adaptive enterprise architectures and agile connectivity to laboratory instrumentation and applications can provide a strong foundation for Biopharmaceutical Life Cycle Management.

While digital transformation has emerged as one of the highest priority initiatives in the scientific industry as a whole, the development of software tools designed to address the specific needs of the biopharmaceutical company have significantly lagged behind. Processes utilizing single-use bioreactor technology and continuous manufacturing have also presented significant hurdles for digital transformation efforts within the biopharmaceutical industry. The seamless integration of workflows, laboratory equipment and contextualized data across the biopharmaceutical lifecycle has been one of the major challenges preventing operational efficiency.

Innovative Solutions for Accelerating Biopharmaceutical Development

Now more than ever, eliminating these roadblocks is imperative for reducing the time to market and the overall cost of developing biological therapies and vaccines. Two companies with cutting edge technologies have now joined forces to provide a novel solution for effectively addressing these challenges within the biopharmaceutical laboratory. IDBS, a leading innovator in Biopharmaceutical Lifecycle Management (BPLM), and Scitara, a pioneer in laboratory IoT, have entered into a strategic partnership to create a combined solution that will significantly extend IDBS Polar™ BPLM’s laboratory data connectivity and instrument integration capabilities. This integrated solution augments the Polar workflow capabilities by addressing the challenge of sharing and digitalizing laboratory data across the biopharmaceutical lifecycle, while ensuring data integrity and supporting insight.

Scitara’s advanced tools for sophisticated workflow automation are powering the digital transformation of scientific laboratories by enabling them with modern lab data connectivity infrastructure and solutions to accelerate biopharmaceutical development.​ The Scitara Digital Laboratory Exchange (DLX™) cloud platform revolutionizes data connectivity by combining the benefits of modern cloud-based architecture, with vendor-agnostic, secure, regulatory compliant, laboratory-specific functionality​. Their universal connection technology provides the conduit for constructing multi-destination data flows and configuring event-driven data exchange between multiple connections, including legacy devices, instruments and applications.

The benefits of this synchronized solution include:

• Enables sharing and digitalizing laboratory data across the biopharmaceutical lifecycle
• Removes risky and inefficient manual processes
• Delivers high quality contextualized data to support informed decision making
• Reduces the time and complexity of implementations via plug and play integration with instruments, applications and enterprise platforms
• Ensures data integrity and facilitates regulatory compliance through secure data communication and exchange infrastructure

Conclusion:

Biopharmaceuticals are swiftly becoming the new frontier of medicine. Time to market and reduced cost of development are of critical importance in the quest to bring these innovative therapies quickly to market. Not only are these drivers crucial for the biopharmaceutical company to remain competitive, in the case of the current COVID-19 pandemic, it is imperative to saving lives.

Effectively managing the biopharmaceutical life cycle requires digitally transforming the entire developmental workflow through the elimination of data silos and manual processes. Once digital connectivity is achieved, data accessibility and data integrity is facilitated through the application and integration of multiple innovative informatics solutions. Best in class informatics tools such as the Scitara DLX™ platform in concert with the IDBS Polar BPLM platform are specifically designed to address the unique operational and technical challenges of the biopharmaceutical laboratory. The seamless integration of these workflows, instrumentation and data provides the foundation needed to efficiently manage the biopharmaceutical lifecycle, ultimately reducing the overall time and cost of developing these novel therapies.

Why it Matters for You

The biopharmaceutical industry is poised to revolutionize the future of healthcare. Challenges that are unique to the industry must be overcome to realize the full potential of these life-changing therapies. Implementing an effective Biopharmaceutical Lifecycle Management approach addresses many of these challenges and can be achieved by incorporating the following principles into your overall digital transformation strategy:

• Digitally transforming the entire biopharmaceutical development workflow, including instrument connectivity, will provide a solid foundation for effective Biopharmaceutical Lifecycle Management.
• Integrating the entire workflow for seamless peer-to-peer connectivity for all laboratory instrumentation and applications will enable a comprehensive data transformation and workflow automation.
• Employing best in class solutions, such as the Scitara DLX™ platform in concert with the IDBS Polar™ platform, will provide you with the necessary tools to achieve operational excellence in the biopharmaceutical laboratory.
• Adopting a “data first” approach to Biopharmaceutical Lifecycle Management will reduce the time and cost of developing novel biological therapies and vaccines.

About Astrix

Astrix partners with many of the industry leaders in the informatics space to offer state of the art solutions for all of your laboratory informatics needs.  With over 25 years of industry proven experience, Astrix has the informatics specialists and business process analysis tools required to develop and implement the solution that works best for your enterprise. Our domain experts have helped hundreds of companies globally effectively navigate their digital transformation journey, connecting people, processes and systems to accelerate the advancement of science and medicine.