Revolutionary Breakthroughs Build on a Foundation of Evolutionary Technology

By: Frank Corden, Senior Director of Enterprise Solutions, New England Controls

Clearly the most popular event of the last day of the conference was the conversation with Steve Wozniak.  The audience was overflowing seating capacity by two or three times, and was riveted to hear Steve’s comments.

And his insights didn’t disappoint.  Just listening to someone who has been one of the giants of technology, leading a company that has transformed the way we work, the way we communicate, the way we investigate and share the world around us is enlightening with both the complexity of what was accomplished and the simplicity of the original intent.  As I watched the interview, I was reminded of a documentary I had watched on a Lufthansa flight back about the contrast / conflict between Steve Jobs and Bill Gates.  The video is part of the Face to Face series and is entitled Face to Face Jobs vs Gates – The Hippie and the Nerd.  An intro clip in English can be found on YouTube.  The full video is available from several pay services, but I did find free copies in French and German on YouTube.  If anyone out there knows of the full piece in English, please drop me a note at frank.corden@newenglandcontrols.com. In addition, there is a pretty insightful video produced by the BBC that is an interview with the two rivals, “Steve Jobs and Bill Gates Face Off.”

What I liked about the Face to Face documentary was that it provided insight into two aspects of collective achievements of Microsoft and Apple; serendipity and synergy.  Until I viewed the video I didn’t realize that in its early days, Apple was buying software technology from Microsoft.  It was enlightening to realize that without those deals, maybe Microsoft doesn’t have the funds to develop MS Windows and as a result MS Office and the other products Microsoft dominates the marketplace with.

The computerized / connected world we live in today maybe doesn’t happen without Gates and Jobs, Microsoft and Apple.  Or if it does happen, it certainly would look different.  Yet it wasn’t just these two companies.  Would we be so connected without the World Wide Web?  Of course not.  Our mobile phones and tablets/laptops wouldn’t be nearly so useful and we wouldn’t be as productive without wireless networks enabled by telecom giants like AT&T, Verizon and numerous international competitors along with the chip and networking hardware manufacturers like Motorola, Cisco, Intel, AMD and their competitors.  It has taken contributions from dozens or even hundreds of companies to get us to where we are today.  The iPhone and its numerous Android competitors wouldn’t be nearly so cool (or useful) without the web, YouTube, Amazon, Google, and the myriad of other content providers, app developers, and camera component manufacturers.

I see the same sort of revolution developing in Biotechnology.  Biotech manufacturing has long been viewed as more art than science.  In part that is due to the recognized (or maybe unrecognized) complexity of our factory, the living cell.  It’s the equipment and materials vendors, many of who were exhibitors at BPI, which are building that evolutionary technology foundation.

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Ongoing developments in analytical technology are contributing to that evolutionary foundation.  A couple of examples are:

  • Chromatography and mass spectrometry are greatly improving our ability to characterize the finished product. The one knock on Biotech drugs was you couldn’t definitively determine their composition, leading to the concept of biosimilar versus generic active ingredients.  I see a day maybe not that far in the future, when two biologics can be directly characterized from the primary amino acid sequence all the way to the definitive glycosylation pattern.
  • Raman spectroscopy and other optical techniques are rapidly developing to support real-time control of the bioreactor and purification skids by enabling Process Analytical Technology (PAT).

Continually improving equipment is supporting reduced cost of manufacturing and improved product quality and consistency.

  • The explosion in options for single use manufacturing is reducing capital equipment costs and reducing energy as well as water usage. As biotech goes greener, we all benefit.
  • Improved purification techniques are facilitating more continuous manufacturing and accelerating work in process material throughput and reduced manufacturing times.
  • Integrated automation is enabling the ability to use PAT (noted above) and reduce resource requirements for personnel. You can do more with fewer operators.
  • Improved automation also enables real-time data collection and data transfer across the manufacturing plant. Remote resources can monitor and in fact control plant operations. This furthers the reduction in labor by eliminating manual data entries and transfers as well as supports the development of review by exception strategies to speed batch release.

Improvement in the quality and characterization of raw materials and product contact consumables improved product quality and manufacturing consistency.

  • Raw material suppliers are reducing variability in their products thereby reducing the variability in the process.
  • By partnering with their customers, these suppliers are enabling biotech manufacturers to better characterize their processes and determine relationships between supplier quality and improved yields.
  • Consumables suppliers are improving manufacturing and adding features in single use products to reduce failures and minimize the potential for operator error during assembly and use.

So when one of the large biotechs who presented at BPI this week or one of the small emerging companies makes that next big step change in reducing production cost or product time to market, we’ll remember them for changing the business.  But let’s not forget all those companies employing an army of scientists, engineers and entrepreneurs who made the small improvements that were the foundation of the breakthrough, and without them, would never have happened.

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