BioPharma Lifecycle Management
With new biologics generally taking a decade or more to bring to market at a cost of upwards of US $1 billion, there’s an urgent need to improve the overall efficiency and cost-effectiveness of biopharma development. Yet, according to a recent survey of biopharma development teams, 50% were using legacy applications such as electronic lab notebooks (ELNs) to record process development work and the other 50% were using a mix of paper, Excel, and standalone instrument software. More than 60% reported spending at least five hours a week on data administration and in some cases more than 20 hours a week.
As a result, problems encountered as late as biologics licence application (BLA) submission can uncover missing or unsupported development data which in turn require entire teams to stop ongoing projects and repeat previous studies to address the discrepancies. It simply isn't possible to build an efficient process on this basis.
What’s needed is a better orchestrated development process that drives operational efficiency with comprehensive data capture and curation. This requires a new category of software to create a foundational data backbone across the development lifecycle: BioPharma Lifecycle Management (BPLM). The key to BPLM is ensuring valuable data is automatically captured in context at the point of execution, guaranteeing data integrity and making it easier to gain insight from collective experience. Once this is in place, biopharma companies can finally unlock the strategic benefits of data for advanced modeling and analytics such as machine learning (ML), digital twins, and artificial intelligence (AI).
With effective lifecycle management, biological products can reach the market at least three years faster than the current average according to conservative industry estimates. And it doesn’t stop there; the ability to easily share data with partners such as contract development and manufacturing organizations (CDMOs) and regulatory agencies can be game-changing. For example, post-approval changes – do you have the data to demonstrate to the regulatory agencies that you understand the impact of the change on your process? And tech transfer – how quickly can your contract manufacturing partner start running your process in their facility? Greater insight into all aspects of manufacturing including supply chain, forecasting, environmental impact and cost of goods can encourage more sustainable production practices and improve the availability of cost-effective therapies across the globe.
Polar is the world's first BPLM platform, a cloud-based system designed for efficient workflow execution while curating the data you need to address the biggest challenges in process design, optimization, scale-up and technology transfer.
ICH M10-compliant consistency, quality, and reproducibility for preclinical pharma.
Optimize workflows and integrate process and analytical data to deliver greater insight.