By: Dan UpDyke, market development manager, Life Sciences, Rockwell Automation, and Timothy Wortley, senior product manager, Bioprocess Industrial Automation, Cytiva
You may not be thinking about the future scale-up to commercial production when you’re in the early stages of crafting a new biologic therapy. But it is prudent to keep your long-term production needs at the front of your mind.
That’s because the early design choices you make in your single-use facility can greatly affect your speed to market and ability to show compliance throughout regulatory reviews. These decisions can also impact your production flexibility for future growth.
Securing FDA approval may prove more cumbersome if processing data is not automatically collected. You might need to sift through years of hand-written and difficult-to-isolate data to identify the required information. And if your equipment isn’t designed to communicate between units of operation you may find that setting it up for production runs is a long and onerous process.
For reasons like these, it’s important to remember you’re never too small to think big when it comes to your manufacturing ecosystem. By addressing future needs like regulatory approvals and operating efficiencies early with smart process design, you can scale your operations from development to production with minimal disruption, and be better prepared for future products and expansion.
Future-proofing your single-use production strategy doesn’t equate to major up-front capital investments. You just need the right design philosophy, one that’s built around integrated, standardized equipment, and automated data collection.
Design your risk out
Just consider the challenges that can arise in a single-use process that’s not designed for long-term production needs.
Most likely, your manufacturing process is a hybrid of unit operations that use multiple software platforms. This equipment may not effectively talk to each other. As a result, operators will need to manually configure each asset before a production run. Technicians will also need to work with several vendors to maintain the assets. And IT personnel will need to support, update, and patch the software platforms all separately.
Meanwhile, when equipment isn’t integrated, it’s difficult to automate data collection across platforms. As a result, operators may need to manually collect data from each asset, such as by downloading onto a USB drive. They may also need to reformat the data, if different assets produce it in different standards.
All these manual steps and equipment disparities can add up to make life difficult in your single-use production environment and create tremendous potential for mistakes. They can make changeovers and review times inefficient and lengthy. And they can result in gaps in your data that can compromise your data integrity and complicate regulatory approvals.
One misconfigured parameter on a piece of equipment, for instance, could compromise the release of a batch. Data could also be overwritten and lost when manual downloads are involved. Proper design can solidify the integrity and reliability of your data.
Someone could even walk out of your facility with the USB drive in their pocket – potentially exposing your data to unauthorized individuals. These types of incidents must be considered given today’s ever-increasing cyber threats. In a 2019 survey, half of industrial companies reported at least one data breach or cyberattack in the last 12 months, and 11 percent said they experienced a major intrusion.
So, how do you design your single-use manufacturing process for your long-term compliance and production needs? Consider these key elements:
1. A common network protocol
A standard protocol allows you to connect your disparate production assets, so they can share data and run as a cohesive system.
EtherNet/IP, for example, is a widely used protocol in industrial environments and time-critical applications. It allows secure, real-time information sharing between equipment, systems, and enterprises. And it gives you access to common security measures, like an industrial demilitarized zone (DMZ) and segmentation.
2. A standard equipment platform
When you use standardized instead of customized equipment, you help people work more efficiently.
Operators gain a common interface. So, whether they’re working on a bioreactor, filtration skid or purification skid, they get the same look and feel across assets. Maintenance technicians only need to work with one support provider. And IT personnel can worry less about maintaining and securing different systems from multiple vendors, which can help reduce costs and potentially reduce security risks.
Process engineers will also appreciate that the equipment produces consistent data, with no need to reformat it.
3. Automated data collection
Using a batch historian to automate your data collection will save you time and reduce risk in the long run. It can reduce the likelihood of errors, compared to workers manually pulling and managing data. It can also give you fast, easy access to data to help speed up reviews and regulatory approvals.
A historian can also help you manage quality. When combined with analytics software, it can help you identify issues like temperature excursions as they happen, rather than months later when you pour through data. And because your data is centralized, you can easily put insights into reports and share them with others in your organization.
4. A scalable architecture
Building a flexible, integrated architecture for your facility doesn’t only help you in the short term. It sets you up for future expansion and increased capacity.
Adding additional equipment can be a challenge if flexibility isn’t in the initial design. The equipment must be accounted for in recipe management, unit allocation, and data-collection systems. If a standardized, integrated approach isn’t taken in design, custom SOPs and batch records for each new piece of equipment may be required.
Having the vision and planning to enable future possibilities for your facility are key. Planning for success takes a little effort in the initial stages but can pay huge dividends in the long run.
It’s never too soon to start
By thinking long term about your single-use manufacturing, you can optimize your drug-development efforts today and accelerate product releases in the future.
The right automation platform can meet your initial needs and be expanded for your future growth, helping you avoid a costly replacement at a later date. All you need is a design mindset that prioritizes integrated, standardized equipment and a foundation for future growth.