Takeaways from ISPE Boston Pharma/Biotech Product Show

Author photo: Janice Abel
ByJanice Abel
Category:
ARC Report Abstract

Summary

On September 16, 2019, the ISPE (International Society for Pharmaceutical Engineering) Boston Chapter held its annual product show at Gillette Stadium in Foxboro, Massachusetts.  Overall, the event provides an excellent opportunity for end users, suppliers, equipment manufacturers, and others to learn more about the ISPE Bostonpharmaceutical and biotech products, services, and related technologies.  The more than 3,500 attendees had an opportunity to see new products and technologies from over 400 suppliers.  ARC Advisory Group believes this helps demonstrate the robust nature of the growing pharma and biotech industries.

The success of the Boston Area ISPE Chapter Product Show, and – in large part - the success of local biopharma industry is due to the collaborative environment and sharing of both knowledge and best practices among chapter members, local experts, industry and academia.   The ISPE Boston Chapter has been sponsoring this event for 30 years and starting from the very first event (held at what was then a Howard Johnson Hotel in Cambridge) to the multi-faceted event it is today, it has proven to be a valuable and worthwhile event for participants every year.  However, it would be difficult to compare those first few events to the multi-faceted event that ISPE Boston Product Show has turned into today.  Over 3,500 people attended, mostly from the New England Area, but the event also drew product and service suppliers, attendees, and world-class presenters from all over the country.

Key takeaways from the event include:

  • Pharma and biotech industries are still robust in the Boston area with investments attracted by the immense knowledge and academics from industry and the universities.
  • Pharma and biotech companies are still hiring in the Boston Area and other parts of the US.
  • Pharma and biotech companies are digitalizing and adopting Industry 4.0 implementation strategies and best practices for clinical manufacturing and other manufacturing facilities because of the business value.
  • Rapidly growing pharmaceutical companies must deal with challenges ranging from regulatory challenges to operations needs to real estate expansion requirements.
  • Innovation and disruptive technology including emerging life science technologies and bio-tools can transform the landscape for scientific discovery and manufacturing, enabling faster treatments for patients.
  • Modular automation and production units enable faster time to market, increased automation efficiency, and higher flexibility with plug-and-produce capabilities.
  • New facility designs for new advanced therapy medicinal products (ATMP) are available to improve automation, cell lines, and other manufacturing requirements to rapidly treat and cure diseases.
  • New CAR-T cell therapy production methods are being adopted for electronic batch records and laboratory information systems, supported  with electronic signatures, cybersecurity and cloud platforms.
  • Projects need to progress faster from pilots, to clinical tests, to production to reduce tech transfer requirements and costs.
  • Regulations continue to have significant impact on pharma and biotech industry product roll outs and manufacturing.
  • The event featured a plethora of newer sensors, flowmeters, analyzers, and other instruments, many  with more sophisticated analysis capabilities.
  • Islands of automation still exist, including many disconnected skid-mounted units.    Connected plants remain the exception, rather than the rule.
  • Manufacturing innovation in pharma is more important today than ever before.
  • There is still a lot of construction in the Boston, Cambridge, and surrounding areas for the pharma and biotech industries.
  • Companies are producing personalized medicine in smaller batches and batches of one.
  • Batch processes are being converted to continuous processes and integrated with upstream and downstream processes.
  • The use of modern manufacturing technologies like virtual and augmented reality and advanced analytics is disrupting this industry.

Insights and Intelligence Galore!

The event included an educational session, a professional development program, student development program, Women in Pharma event, Veterans in Pharma event, and more than 40 hiring companies.  There were also more than 400 tabletop exhibits and presentations by industry experts.

Digital Transformation in Life Sciences

Mike Cody, Senior Solution Architect, for New England Controls, Inc. (NECI), an Emerson Impact Partner, described NECI experiences, Industry 4.0 implementation strategies, best practices, and lessons learned from a fully digital clinical manufacturing project.  According to Mr. Cody, by defining a strategy for implementing new digital technologies, NECI can deliver on the vision of a fully digital manufacturing facility.   He described how the life science landscape is changing along with the digital architecture goals.  It is important to align technologies, not just with the bioreactor, but holistically with the upstream and downstream operations. He discussed NECI’s digital transformation journey and the company’s vision for life sciences technology adoption and selection.  Mr. Cody also discussed the role that organizational culture plays with technology deployment.  Companies need the same information digitally that was previously available on paper, plan for change management, and enable the culture to adapt to new digital technologies.  It is important to be flexible enough to quickly implement changes, but also be able to make changes that allow you to deploy new applications quickly.  “What was done in the past, will not get you to where you need to be in the future,”  he commented.  Mr. Cody then described a paperless, digital clinical manufacturing project with substantial benefits that included:

  • 35 percent reduction  in manufacturing FTE (full time equivalent),
  • Cycle time reduction from 12 days to six days, which allowed the company to double its capacity
  • 40 percent reduction in process variability
  • Zero manual deviations after three months (e.g., all the batches look the same and operators are limited to reduce process variations)
  • Batch reviews reduced from three days to three hours

Long-time ISPE member, John Hannon from Commissioning Agents, Inc. (an  old acquaintance of the author) provided his perspective on data management tools for personalized therapies.  This session provided a case study of how one company designed, implemented, and validated a projection MES and electronic batch record (EBR) system for CAR-T cell therapy production.  The project utilized a 2D barcoding, electronic signatures, and data encryption and operated on a cloud platform across multiple continents.  Other presentations dealt with the challenges of a rapidly expanding pharmaceutical company from real estate to regulatory and obtaining capital, plus what’s new for single-use and modular solutions.

Product Show

While  many exhibits stood out and there was not nearly enough time to visit  all 400 suppliers exhibiting at the Boston ISPE product show, we came across several that were particularly interesting.

 

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Keywords: Pharmaceutical, Biotech, ISPE Boston Product Show, Digital Transformation, ARC Advisory Group.

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