The History Of Pharmaceutical Manufacturing: Industry 1.0 to Pharma 4.0

An ascending graph of the evolution of Pharma 4.0. Starting from 1760 and ending in 2023.

A lot has changed since the 1700s in the whole world, but especially in the pharmaceutical industry. Over the past 250 years, four industrial revolutions have swept the world, drastically changing the way we manufacture items and their availability – including pharmaceuticals. 

Industry 1.0

The first industrial revolution spanned from 1760 to 1830, with its origins in Britain. It was marked by new technologies in textiles, iron working, and other industries. It took goods that once took days, weeks, or even months to painstakingly craft by hand and turned them into mass-produced goods made by machines. Agrarian societies soon developed large urban centers. 

Even in the moment, Britain was incredibly aware of the impact this revolution was having and took measures to prevent the spread of technology. Officials actually outlawed the export of manufacturing techniques, adept workers, and, especially, machinery. Eventually, as all technology and knowledge does, it spread anyway. Belgium followed suit to Britain and experienced a massive revolution. At the time, other European countries, such as France, were entangled in revolution, so their development took longer. On the other side of the pond, the United States was a fledgling nation, still reeling from their own revolution, although we, too, would soon embrace industrialization.

While this first industrial revolution did not have immediate impacts on the pharmaceutical industry, it (along with the scientific revolution of the 17th century which opened the door for experimentation) laid the foundation for the revolution of the pharmaceutical industry that was to come.

Industry 2.0

In the late 1800s and early 1900s, it became clear the world was experiencing a second industrial revolution – this time led by the United States and Germany. The use of lighter weight and synthetic materials, as well as new energy sources, opened the door for new expansion and growth. People’s lives revolved more around the clock than the sun as the traditional 40-hour work week and 8-hour workday were established.

This was also an era of great movement and advancement for the pharmaceutical industry. Two German immigrants established Pfizer – now a household name – in 1849. Bayer was founded in 1863, originally as a dye manufacturing company. 

On the scientific end of things, the germ theory was developed! This revolutionized the way diseases were seen and treated. Additionally, Johnson and Johnson introduced the idea of septic surgery and wound treatment. With these advancements came the introduction of the 1906 Pure Food and Drug Act by the FDA – the first of many regulatory guidelines we have come to know and love. 

Pfizer focused heavily on providing medicines for the Union war, but other players were about to enter the game. Players like Colonel Eli Lilly, who would pave the way for pharmaceutical manufacturing. After the war, Lilly was one of the first industrialists who focused heavily on R&D and manufacturing after establishing his pharmaceutical business in 1876.

Another example is Edward Robinson Squibb, who was also a military man. He actually threw drugs overboard when he found their quality to be lacking. In 1858, he set up a laboratory that would lay the foundation for today’s BMS. 

In Europe, Switzerland was rapidly developing a home-grown pharmaceutical industry in the late 1800s. Large textile and dye manufacturers realized their products had antiseptic properties, amongst others, and saw the potential for them in the pharmaceutical market. 

It’s strange to think of our pharmaceuticals having roots in dye, but we have that to thank for aspirin. At the turn of the century, Bayer commercialized aspirin. Soon after, during the first two world wars, we would see not only the creation of pivotal medication, such as insulin and penicillin, but the push to make them widely available through mass production, directly made possible by the innovations and advancements of the second industrial revolution.

Industry 3.0

The third industrial revolution came into play in the last half of the 20th century with the invention of the computer, rise of electronics, and introduction of Nuclear energy. 

As for the pharmaceutical industry as we know it now, this was perhaps the most pivotal revolution. In 1962, Willis Whitfield invented the cleanroom – which we, as clean air experts, think is pretty cool. Moreover, in 1961, the United States was shaken by the Thalidomide Scandal, where over 10.000 babies were affected by the Thalidomide drug. Many died while others and their family went on to experience life long impacts. This prompted the FDA to increase regulation and testing of drugs prior to licensing. In 1964, the Declaration of Helsinki clearly delineated the difference between scientific prescription medicines and other chemicals by placing ethical structures on clinical research. 

In 1971, the European Union (EU) Good Manufacturing Practice (GMP) for Medicinal Products for Human and Veterinary Use – Annex 1 was introduced. We now lovingly refer to this pivotal regulation as Annex 1. Over the years, it has seen many adaptations and updates and is still one of the most pertinent set of regulations around. 

This was an era of introduction for many of the institutions we are incredibly familiar with today, but it was also the introduction of the mass production of technology we hold so dear. Technology that makes our life and field possible. Along with cleanrooms, particle counters became widely available. Computers made research easier and information more available. Communication technology brought people together all over the world for collaboration as it had never before been seen.

This was the start of the world standing as one to face disease and illness.

Industry 4.0 and Pharma 4.0

Now we find ourselves in Industry 4.0 – as well as Pharma 4.0: the pharmaceutical industry’s mirror of the fourth industrial revolution, ushered in by the internet. With this explosion of technology and communication, we have seen massive shifts in the way industrial organizations operate. With the internet, we’ve seen the development of Artificial Intelligence (AI), automation, and advancement of robotics for detailed operations.

The International Society for Pharmaceutical Engineering’s (ISPE) coined the term Pharma 4.0 and developed it on a 4 part operating model: resources, information systems, organization and processes, and culture. Pharma 4.0 hinges on information access, automation, innovation, and digitization. It is the current epitome of integration of technology into the pharmaceutical industry to maximize efficiency and innovation. It takes all the advances of the last several hundred years and culminates them into a drive for excellence and advancement.

Human innovation at its finest.

But there’s always tomorrow to make it better.

Here at LWS, we are dedicated to innovation and advancement. We’ve poured our years of expertise into the ApexZ: the particle counter that defines excellence. Learn how the ApexZ can change your business today. 

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