Ramping Production Is No Easy Feat
Scaling manufacture is a high-stakes effort now in the spotlight for COVID-19 vaccines. Industry 4.0 technologies could change that.
Robotic testing machine in drug manufacturing. Courtesy of Aleks Marinkovic.
No matter the manufacturing process, starting a next generation line or scaling a pre-existing process is extremely difficult. Just ask Tesla or Intel. Elon Musk even suggests to not buy a Tesla car when they are ramping up production due to quality issues. Both upstart manufacturers and incumbent players take on big risks technically and financially to launch new manufacturing capacity. That’s why the use of the Defense Production Act and Operation Warp Speed were so critical to maximizing our chances to mass produce a COVID-19 vaccine and be able to inoculate the population before the virus mutates.
Unlike some verticals, pharmaceutical manufacturing requires the utmost precision and process traceability “so that every dose is safe and effective, and free of contamination and defects”, as stated by the FDA’s Office of Pharmaceutical Quality. That’s why a mix-up at an Emergent BioSolutions facility, which produces Johnson & Johnson’s vaccine, is a bit alarming. While yield issues usually occur due to the complexities of the manufacturing process, the conflation of ingredients on a high-profile program is an unnecessary step back to get doses out the door and into arms. At the very least, additional partners such as Merck can adapt their vaccine manufacturing lines to produce the more traditional Johnson & Johnson vaccine.
In the case of Pfizer’s and Moderna’s mRNA based COVID-19 vaccines, large-scale production has never happened before. Pfizer estimates spending over $2 billion on the program for product development and machinery to produce a prospective efficacious vaccine. Once approved, the challenges throughout the rest of the supply chain also began for producing the protective coating of the mRNA, the liquid nanoparticles, as well as vials and freezers for storing the vaccine doses before injection. All of this required incredible human coordination and technological prowess to go from lab to jab in under a year.
The ultimate promise of Industry 4.0 technologies is enabling capital efficient scaling for manufacturing enterprises. Envision an ecosystem of rapid prototyping in a cloud simulation environment, using specialized process capabilities offered at little to no cost through APIs, tinkering until you get it right, and then pushing a few buttons to synchronize it directly to a local factory with available robots and machinery that self-learn the best way to manufacture. An ecosystem like this is what we have today in the cloud software business and if brought to the physical goods world it will significantly reduce the risk and resources required to ramp an industrial business. Cloud software platforms and e-commerce startups flourished post Amazon Web Services launch due to the flexibility of ramping up and down computing needs while also reducing the friction to getting started. Industry 4.0 maturity could trigger a similar inflection point for manufacturing startups. History is littered with manufacturing innovators facing bankruptcy due to the capital intensive nature of manufacturing. Imagine the possibilities for business innovation (i.e. Tesla) and human progress (i.e. novel vaccines) when Industry 4.0 comes to fruition reducing the barriers to entry and scale.
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Assembly Line
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Read more at Jabil
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Read more at The Engineer
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Date: April 1, 2021
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Read more at Semiconductor Engineering
Surge Demand
In case you missed it, the Ever Given is now dislodged from the banks of the Suez. Automotive companies continue to face chip shortages causing halts to production. The digital transformation of industrial conglomerates heats up with Hitachi buying GlobalLogic. Reinforcement learning continues to move beyond games and into the real world.