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 in mind.
The early design choices you make in your single-use facility can greatly affect your speed to market, production flexibility for future growth, and ability to show compliance throughout regulatory reviews.
Securing FDA approval may prove 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. If your equipment isn’t designed to communicate between units of operation you may find that setting it up for production runs is an onerous process.
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 prepared for future 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
Most likely, your manufacturing process is a hybrid of unit operations that uses 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 their assets. And IT personnel will need to support, update, and patch the software platforms 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 and reformat the data if different assets produce it in different standards. Someone could even walk out of your facility with the USB drive, potentially exposing your data to unauthorized individuals and increasing cyber threat risks.
All these manual steps and equipment disparities make life difficult in your single-use production environment and create potential for mistakes. They can make changeovers and review times inefficient and lengthy and result in gaps in your data that can compromise data integrity and complicate regulatory approvals.
One misconfigured parameter on a piece of equipment 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.
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 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.
2. A standard equipment platform
When you use standardized instead of customized equipment, you help people work more efficiently.
Operators gain a common interface and 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, reducing costs and 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. With centralized data, you can easily put insights into reports and share them with others in your organization.
4. A scalable architecture
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.
The right automation platform can meet your initial needs and be expanded for your future growth, helping you avoid a costly replacement later.
It’s never too soon to start
Planning for success takes a little effort in the initial stages but can pay huge dividends in the long run.