Dark factories for a bright future

Much like medicine itself, drug manufacturing has evolved rapidly over recent decades. At the cutting edge of this production are dark factories – automated manufacturing facilities capable of operating with the lights off. Dark factories represent the next generation of technological advancements within the biopharma industry, which is the natural evolution of “Pharma 4.0.”

In this article, we’ll outline how these dark factories can create a biopharma manufacturing landscape that is safer, more efficient, and designed with the future in mind.

Eliminate variability to reduce risk

Consistency is paramount in biological manufacturing. While there are many safeguards in place, variability in the production process of therapeutics can alter the pharmacological properties of a medicine, otherwise known as clinical drift. For example, the monoclonal antibody Cetuximab was found to have a 22% difference in pharmacokinetic exposure in patients when comparing antibodies produced at two different facilities. Fortunately, this incident of clinical drift did not affect the compound's efficacy, but it was nevertheless concerning. As treatments become increasingly complex, the demand for precise, repeatable, and scalable manufacturing processes will also increase.

Dark factories offer a viable solution to this problem. By automating the manufacturing process, human inconsistencies can be removed. This is especially beneficial when aseptic production is required, as people represent a major source of contamination on the factory floor. Robotic machines offer both sterility and precision in the production of therapeutics, and quality control checks can be built into the process to catch malfunctioning components immediately, preventing affected products from entering the supply chain. Distancing people from the manufacturing process also improves worker safety. Factory staff have significantly fewer interactions with dangerous chemicals and machinery, reducing the number of workplace injuries. Thus, dark factories improve the safety of biopharmaceuticals, both at the manufacturing plant and in the hospital.

More medicine with less energy

Dark factories would also provide a more efficient production system. Robotic production can occur around the clock, seamlessly performing multiple tasks in parallel. This speed is a powerful tool to address drug shortages. However, for automated manufacturing to run smoothly, systems must be able to communicate with each other seamlessly. This complex software array can be difficult to set up, often requiring outside experts to implement. However, when successfully installed, biopharma companies will see dramatic benefits from automating their production facilities.

In addition to 24/7 manufacturing, dark factories have the added benefit of lower utility costs. As the name implies, dark factories require little to no lighting, and expenditures on temperature control via heating and air conditioning can often be reduced. These efficiencies can be further enhanced by location. Dark factories have increased geographic flexibility, as they don’t require proximity to population centres with large, highly trained workforces. This allows companies to place dark factories where energy and land are cheaper, and in places where production materials are more accessible. Together, these characteristics allow for the design of a more efficient biopharma manufacturing system.

Designed with the future in mind

The idea of a fully automated dark factory operated by robotic machinery may certainly feel like science fiction, but dark factories hold incredible potential for addressing challenges firmly tethered in reality.

As previously touched upon, dark factories are more flexible in their location. This will allow production to occur in geographies where access to renewable energy sources, such as wind or solar, are abundant, moving us towards a greener future. Dark factories are also better equipped to realise the potential of personalised medicine. Advanced therapies, such as cell and gene therapies, are often difficult to scale up due to the time-consuming production process. Automated manufacturing could dramatically accelerate these timelines, allowing patients to receive individualised treatments in a timely manner.

Finally, dark factories also offer new job opportunities. Despite dark factories being completely automated, they are not unmanned. Engineers, programmers, analysts, and more continue to play a vital role in the running of these facilities. These jobs offer fulfilling and engaging career opportunities for workers already in the biopharma industry, as we all strive to make the production of life-saving therapeutics safer and more efficient.

It’s clear that embracing automated manufacturing will benefit everyone, and recent guidance from the FDA concurs. A draft of the FDA guidance released in December 2023 states: “[The] FDA encourages the early adoption of advanced manufacturing technologies (AMTs) that have the potential to benefit patients by improving manufacturing and supply dependability and optimising development time of drug and biological products.” In addition to these benefits, dark factories reduce on-the-job risks for workers and offer new and rewarding career paths. Furthermore, it may prove easier to transition dark factories to renewable sources of energy, thanks to their inherent geographic flexibility.

While there are almost certain to be challenges along the route to implementation, dark factories are a bright spot in the future of biopharmaceutical manufacturing.