The global pandemic is shining a spotlight on the power of biologics, both vaccines and antibody therapeutics, to prevent serious infections and treat disease. It’s also raising questions about why it typically takes so long and costs so much to bring these products to market. This has long been a murky topic and is usually discussed in terms of risk: biologics are highly complex both in terms of their structure and mode of action and for every successful product that makes it to market, there is a long trail of unsuccessful candidates. Many end up failing at the last hurdle, clinical trials, after millions of dollars have already been spent.

What many people outside of the industry don’t realize and would be surprised to know is that the data backbone that ties together all the activities from research and discovery through process development and manufacturing is still mainly Microsoft Office documents. In a recent Aspen survey, 50% of the participants 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. In addition, 62% of participants reported spending at least five hours a week on data administration and in some cases more than 20 hours a week. So why, when clones can now be grown and screened on a chip and digital twins can apply the power of AI to predict and increase process performance, is this still the industry’s Achilles heel?

There is a plethora of software applications designed to tackle different aspects of product and process development, from design of experiments (DoE) through instrument integration/automation and data aggregation/visualization. Yet the problem with these point solutions is that they don’t address the core challenge: capturing context-rich data at the point of entry with the right metadata and structure to enable searching, reporting, and analytics across the development lifecycle. The promise of digital transformation and biopharma 4.0 is exciting, but even the most advanced ML/AI applications are useless if the source data hasn’t been properly curated. Data curation after the fact is time consuming, costly, and error prone; contextualized data capture should be an integral part of scientists and technicians daily work rather than an afterthought.

What’s needed is an entirely new category of software: Biopharmaceutical Lifecycle Management (BPLM). A multi-faceted problem requires a multi-faceted solution, and at IDBS we’ve identified three core pillars that are necessary to both create and benefit from a comprehensive data backbone across the development lifecycle. These pillars are Workflow, Integration, and Insight. Standardized workflows that accommodate both the flexibility needed for early development and the additional checks and controls needed for clinical supply are key to ensuring comparability of data while also significantly improving operational efficiency. Plug-and-play instrument connectivity eliminates the problems of having key data locked away in proprietary formats and ensures data integrity. Advanced insight capabilities enable an efficient and effective feedback loop to apply learnings gained at different scales to both maximize the usefulness of process modeling and simulation and focus development efforts on the areas of greatest impact to product quality and yield, or the percentage of usable product retained at the end of the manufacturing process, is a critical factor for biologics and particularly viral vector vaccines. 

Once this is all in place, 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 CROs and CDMOs and regulatory agencies can change the game in ways that haven’t even been estimated yet. 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. 

 At IDBS we believe the future of biologics is bright and the time is now to address the gap that’s been holding back their potential. 

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