In an article, From Industrial To Investment Strategies In The Life Science Sector, Life Science Leader magazine has a great recap of some of the issues pharmaceutical and biotech manufacturers face in their manufacturing processes.
The article highlights presentations from the Emerson Exchange technical conference held in Anaheim, California this past fall. The article opens noting that many larger companies have grown through acquisition:
…nearly every one an amalgam of acquisitions and legacy systems, continue to resist sweeping changes in manufacturing, and life science investors share their avoidance of the manufacturing challenge and opportunity.
The process from molecule to medicine is often very separate, and not well connected:
Automation in pharmaceuticals and biotech has succeeded in a vertical sense, he said; engineers have used traditional sensing, feedback, and control mechanisms effectively at various points along the production line. But such solutions tend to be unique to each factory and without linkages between the different production stages, from process development to clinical and commercial manufacturing.
The benefits of this integrated approach:
Immediate advantages of the automated banks over traditional scale-up modeling systems included more runs and greater throughput, more successful runs, operator efficiency, and the ability of the set-up to integrate with process-control technology. Such automated banks mimic process control strategies used at pilot and production and minimize data variance between bioreactors, batches, and facilities. Ideally, the scaled-up production system would follow not only the key process parameters produced by the small-scale model, but also — horizontally — its overall automation and bioprocess control approach.
In earlier posts such as Automating Process Development Labs, we highlighted how technology can play a role in integrating the stages together. As the article highlights, the organizational structure and culture is often the limiting factor:
…the sequential manufacturing functions at most companies — laboratory, clinical, and large-scale production — still exist in separate silos and typically resist talking with each other. For instance, the process development (PD) lab may consider compliance issues so important to clinical manufacturing as outside its responsibility and thus reject the inclusion of compliance modules in its own work. Similarly, clinical manufacturing may react negatively when the company introduces SAP systems into its area.
The benefits of this integration may require a change in organization and culture. The article’s author concludes:
My take: Too few companies and investors value compound optimization and other supply chain components that can greatly affect drug potency, stability, and delivery — and thus safety and efficacy — in clinical trials. What are some ways all the players — top management, operations, investors, and others — could collaborate to solve a common problem like manufacturing, that sinks so many companies developing potential medical breakthroughs? The life science industry awaits new leadership that can make the critical connection between optimized manufacturing and competitive advantage, as a bridge from industrial to investment strategies.
What’s your take?