A pillar of strength — asking why the US has such a strong presence in pharma manufacturing

Glenn Thorpe, senior vice president sales, Datwyler, looks at why the US is a strong pillar of pharmaceutical manufacturing.

The US is already a key market for pharmaceutical manufacturing, and will gain even more importance in the next five to 10 years. The largest number of biotech companies worldwide can be found in the US, investing more than $75 billion per year. Those investments are set to be growing — not only due to further developments in the biotech sector, but also due to a shift from foreign-based to home-grown facilities and manufacturing sites.

Moving or expanding manufacturing in the US is a current trend that stems from different developments. One of the most important development is that the political landscape in the country shows a strong affinity for US-manufactured goods, also in the pharmaceutical sector. As J. Miller shows in his article ‘Will Pharma Manufacturing Move Back to the US?’,¹a number of manufacturing companies already have facilities in the US. This development is particularly strong in the sector of contract manufacturing organizations (CMOs), while active pharmaceutical ingredient (API) manufacturing sites are not as present.

One of the companies that chose the US as one of its key manufacturing sites is the Swiss-based international industrial supplier Datwyler. The company is currently building a new production facility in Middletown, Delaware, which is scheduled to start production in the second half of 2018. It will be their second US-based operation for healthcare, but the first facility to incorporate cleanroom manufacturing in accordance with the company’s own First Line standard. Other First Line aligned facilities are based in Alken, Belgium and Pune, India.

The decision for Datwyler to build a future-oriented manufacturing site in the US has, however, not been a singular, short-term decision. Opening a new facility which incorporates specific cleanroom manufacturing standards in the mid-Atlantic area of the US unifies the current trends and developments in the pharmaceutical industry: (1) the move to the US as a base for pharmaceutical manufacturing, (2) choosing the mid-Atlantic region — a pharmaceutical hotbed — as manufacturing location, and (3) the advancement of cleanroom manufacturing which also incorporates elements of digitisation.

Moreover, the idea that local markets increasingly demand locally manufactured pharmaceutical components has been a driving force in the investments made by the company in the last years. That this particular trend is currently becoming strong amongst manufacturing companies shows the industrial supplier’s awareness of industry trends and developments. As CEO Torsten Maschke revealed: “As a globally acting company in the pharma industry, we need to not only observe trends but anticipate and shape them ourselves. With our new facilities in the very important markets USA and APAC, we feel we have done exactly that.”

The location of the newly built facility is defined by its history as a traditional stronghold of manufacturing, particularly in the pharmaceutical sector. The mid-Atlantic region, that includes New Jersey and Delaware for example, has long been a hotbed for pharmaceutical manufacturing. This development is not stagnating but getting stronger. A number of international companies such as Datwyler are expanding or moving operations to states like Delaware — an important trend in today’s global economy.

Companies expanding or moving to the US also provide a strong vision for the future, not only in terms of job creation but also in terms of research and progression in different industrial sectors. This is especially the case when these companies bring business to the US or future-oriented manufacturing technology that also includes aspects of digitisation and digital features. In Datwyler’s case, the First Line manufacturing standard, a state-of-the-art cleanroom manufacturing concept.

Cleanroom manufacturing will become even more important in the next few years. Whilst it is also used in other rubber and elastomer-processing industries, it is of particular importance for the pharmaceutical industry. Patient safety as one of the crucial factors for the industry, relies, to a great extent, on high-tech drug administration solutions and technologies which are produced more and more in a cleanroom environment. Certain key areas in cleanroom manufacturing will be the focus of further developments and innovations.

Human interaction in manufacturing will be reduced to a minimum to avoid possible contamination of the product. Automation — and therefore also digitisation — will pave the way to even lower particulate levels and risk of contamination. In practice, this will be done through reducing operator handling and processing components throughout the moulding process. This will also impact the rare occurrence of component defects significantly.

Every step of the production process will be subject to high-tech camera inspection, from the moulding process to the washing and to the packaging of the components.

The very tight acceptable quality levels (AQL) in production and the security provided by their component partner will enable any client to deliver their drugs to the patient with confidence.

In summary, the trends described in the above article will be leading the way towards the US consolidating their position as pillar of pharmaceutical manufacturing. Locally based research and development will do its part to underpin this position. The coming years are bright for US based pharmaceutical manufacturing — and new facilities, research and development will further make it an integral part of the future of global health.

Reference:

1. Miller, J., ‘Will Pharma Manufacturing Move Back to the US?’, Pharmaceutical Technology, 2017;41(3).