Integration Priorities of the High-Growth Biotech - Manufacturing

Integration is a key growth strategy for the modern Biotech company. Kitepipe has had the good fortune to work with many emerging and established Biotech companies and observe patterns of integration that are consistent across a number of firms. Here is part 3 of 3 - Manufacturing.

In the old days (5 years ago) an emerging Biotech would not invest in a manufacturing suite - there is a mature environment of contract manufacturers for both small molecule and biologics.  And a GMP facility is very expensive to build and operate.
 
But this has all changed.  As new powerful and proprietary techniques combining genomics, biological synthesis, and personalized medicine emerge, contract manufacturing is not an option - many emerging Biotechs want to or must manufacture their therapy candidates.  If only they had the money...
 
The economics have changed, too - some of our Biotech customers have raised $200m, $500m, $1.2B in the capital markets - in part because a manufacturing suite to deliver tailored or personalized mRNA, CAR-T or other advanced biologics are expensive to build.  This then is the third integration priority of the emerging Biotech - manufacturing integration.
 
A modern biotech manufacturing suite is insanely complex.  Inventory, processes, orders, testing, status, training, specification, and quality must all be managed, and often each has its own proprietary platform.  In the old days (5 years ago) the pace of progress allowed the printing out, wet signing, and scanning of paper documents as a way to move data across these many platforms.  But for many obvious reasons, a "Paperless" operation with pervasive digital integration is now the goal. 
 
 Screen Shot 2021-03-26 at 12.07.11 PM
 
A generic model of GMP integration flows.  Our work with Moderna on integration in their Norwood manufacturing facility helped us understand the scope and requirements of the modern paperless GMP manufacturing suite.
 
If you are interested, contact me, Larry.cone@kitepipe.com for an overview of integration in the modern paperless GMP facility.
 
In summary, integration technology should be a key part of the growth strategy of every modern Biotech.
 
 
Best, Larry 
 

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