Industry 4.0 has reached the cleanroom. Automation and device integration stands out as a pivotal role in revolutionizing the pharmaceutical industry. This crucial communication between hardware and software marks a significant shift toward automation and reducing reliance on manual operations, particularly in the new cell and gene therapy segment.

While still in the early adopter stage, there are more devices coming to market that can automate part of the cell and gene manufacturing process. The advantages are far ranging, especially within cell and gene manufacturing where personnel costs are seen to range between 20-32% of the total manufacturing costs. 

The reality in many cleanroom’s today: Disconnected device data with many manual operations and potential errors

Cleanrooms traditionally have many devices, from bioreactors to centrifuges to incubators, each with their own screens displaying important information. Some of these metrics need frequent supervision whereas others require less regular follow-up. 

What they all have in common is that they create islands of data requiring operators to go over to each workstation to get the latest read-outs or set parameters. This is not only time inefficient and error-prone, but it also means it’s impossible to have a truly real-time overview of the manufacturing process. 

These disconnected data silos have implications for batch records, quality control read-outs and data analytics (including reporting).

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Way forward: Efficiency through device integration 

In comes a system to integrate hardware and software with a number of advantages over the traditional system, allowing users to:

1. Know what is happening in real-time

Instantaneous data collection from devices reduces risk, ensures quality and gives operators more control over their manufacturing process. Without device integration, operators manually record entries, either on paper or in a spreadsheet, and analyze the data after the batch is manufactured. This can cause major issues as manufacturing errors can happen at major sites from time to time.

Sensors from devices, whether wired or wireless, transmit information to software, which can in turn warn a user in real-time if attention is needed. No need to wait until after the batch is complete to know if everything went well, meaning that operators have the opportunity to fix any issue if possible, or stop production and save time if a process is not performing correctly.

2. Centralize data collection and monitor remotely

Plus, the real-time information is stored in one spot so you don’t need to check multiple platforms to piece together the current status. The constant ‘streaming’ of manufacturing data can be stored and accessed from anywhere at any time with software that centralizes all manufacturing data.

Operators and quality teams can access the same read-outs simultaneously, and fewer people need to be at a site during the manufacturing process. The real-time data speeds up the release workflows as people do not need to wait for paper to appear on their desks. It also enables more flexibility within the industry, making working from home possible without compromising on oversight. And in an industry with a staff shortage, integration frees up time so that operators can focus their attention on more important tasks.

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3. Send instructions to devices and keep an overview of activity

The communication is two-way: the devices send data to the software and the software can tell the devices what to do, such as setting temperature and rocker values in bioreactors. Not only does this further ensure standardization, it gives accurate instructions to devices for the manufacturing process. 

In a non-integrated system, operators read setpoints from their batch record to know which temperatures, pH levels, timers, pump speeds etc. are needed for a certain device.

These parameters can be stored locally on the hardware, but there is no automated system to keep a real-time overview of all sets of parameters (or recipes) on all machines.

This makes controlling changes or versions in recipes difficult, and time-consuming if it is done correctly and verifying the parameters is not intuitive.

Software with device integration streamlines this process by sending instructions directly to devices, reducing the potential for manual input errors.

Additionally, MyCellHub can manage the entire batch record or master recipe. These user-friendly overviews give details on which device settings will be automatically sent to each device at specific times. This reduces manual operations.

In this video, a MyCellHub user instructs a Scinus bioreactor what it would like it to do and it reacts in real time.

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4. Enable point-of-care therapy manufacturing

Not many hospitals can produce all the different types of required advanced therapies themselves. Some manufacturers are moving to a “decentralized” manufacturing strategy in which the same therapies are made in different facilities. This reduces complicated supply chains to get personalized treatments as the biological samples do not need to be frozen, sent to another location while staying frozen in transit and then thawed at the new site.

The pharmaceutical companies that enable decentralized manufacturing will require connected devices to keep oversight over the many (hospital) sites where their technology is deployed. Hardware and software integration makes this kind of manufacturing therapies on-site at a hospital a possibility while keeping in line with quality standards.

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Moving forward: Envisioning a more efficient future

The two-way communication in which the software can tell the devices what to do and the hardware reports back the relevant data points ultimately increases efficiency, reduces errors and enhances flexibility within the cleanroom.

Are you ready to see what device integration could mean for you? Get in touch for a demo. Soon you'll see how much time you would save by using a bio-manufacturing execution system in your cleanroom.