Technological advancements over the last few decades have allowed biopharma companies to shift towards partial or fully automated biologics manufacturing. Fully automated factories are sometimes referred to as “dark factories” because the robotic machinery inside can operate ‘lights out’ or without human intervention. These dark factories hold many benefits for the biopharma industry, but the transition from manual to automated manufacturing can seem daunting. Here we’ll discuss common challenges companies face as they automate their production processes and how communication and partnership with experts throughout the transition is key to a successful transformation of your manufacturing process.

Companies within the biopharma industry are familiar with existing government regulations to ensure their products meet the safety standards required to protect patients. However, as companies transition to automated manufacturing, companies will be required to demonstrate the automated process is maintaining or improving the medicine’s quality. A company may also encounter entirely new regulations related to the robotics involved. Furthermore, while all regulatory organizations share the common goal of maximizing therapeutic safety, the specifics of these rules can vary significantly between geographies. 

Experts familiar with the intricacies of the regulatory landscape can be vital partners for navigating these challenges. These partners can offer digital validation processes to create quality assurance and quality control checkpoints that immediately identify issues if they arise. This improves production efficiency and ultimately eases the burden of meeting regulatory standards throughout the process. This up-front investment will help ensure your dark factory passes regulatory benchmarks with ease. The end result is a biopharma product that is safer, more reliable, and delivered faster to the patients who need it. 

The transition to a dark factory requires a comprehensive software system to manage the many robotics working on the production floor. While most biopharma companies already have some data management and production control systems in place, dark factories require a dramatic increase in the virtual ecosystem in order to ensure smooth operations. Companies will need systems for resource management, floor control, execution of manufacturing processes, validation, and more. 
 

There are a variety of software options offered to meet these needs, and companies may be tempted to navigate the market on their own. However, there are several advantages to seeking expert help outside your organization. First, systems compatibility is often challenging. The software programs running a dark factory must be seamlessly integrated with each other, and hiring an experienced team to assist in creating that interface can be invaluable. There are also likely to be unique software requirements specific to the therapeutic being produced. Consulting with experts will be crucial for addressing these concerns. 
 

Finally, while biopharma companies must always take data security seriously, protection against cyber threats is paramount when running dark factories. A properly installed and operated dark factory can meet or exceed the data security offered by non-automated manufacturing, but doing so will require careful planning and maintenance. Partnering with experienced leaders in the field can provide assurance that your biopharma company is protected against data leaks and cyber threats, allowing you to run your dark factory with confidence.

We live in an exciting new age of medicine. Whether it’s personalized cell therapies, precise genome editing, or novel delivery vectors, our ability to treat diseases is constantly improving and evolving. As a result, biopharma manufacturing must remain adaptable and capable of growing to meet new challenges. As companies begin to incorporate dark factories into their manufacturing practices, it’s important to keep the need for flexibility in mind. 
 

One way to do this is to build a modular manufacturing system. This creates the flexibility to meet current needs while also ensuring your system has the adaptability to meet future demands. Figuring out how to build a system that functions as a series of distinct, yet interrelated parts can be challenging. Furthermore, it’s important that a modular manufacturing system scales up or down to meet production demands. Once again, companies can benefit from seeking out those with deep knowledge of how to build an automated manufacturing process that is robust, scalable, and adaptable to the ever-changing needs of biopharmaceutical production.

Dark factories hold incredible potential. According to the FDA, automating biopharma production will be a key tool to “improv[ing] the reliability and robustness of the manufacturing process.” The transition to automated manufacturing requires a serious investment, but companies will see dramatic returns on this investment if they successfully implement this technology. Relying on the expertise of those familiar with the challenges of automation is one of the best ways to ensure proper integration of advanced manufacturing technologies. Doing so will assure companies that their systems are protected from cyber threats, surpass regulatory and safety standards with ease, and are equipped with the flexibility required to rise to the challenges of tomorrow.

 

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David currently serves as the Vice President of Marketing and Consulting Services for CAI. In this leadership role, David keeps up with the latest developments in biopharmaceutical manufacturing and coordinates CAI’s industry-leading Principal Consultants to advance innovation and solve the toughest client challenges. David served on a major pharmaceutical client’s merger integration team and is a 25-year member of ISPE. In his 22 years at CAI David has served in a wide variety of technical, managerial, and technical sales roles. He has over 26 years’ experience in pharmaceutical and biotech manufacturing with a focus on automation and startup project management.