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. And yet, the early design choices you make in your single-use facility can greatly affect your speed to market and ability to prove regulatory compliance. 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. And if your equipment isn’t designed to communicate between units of operation, setting up for production runs is an onerous process.
For these reasons, you’re never too small to think big when it comes to your manufacturing ecosystem. By addressing future needs 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.
Design your risk out
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 and don’t 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, and reformat the data if different assets produce it in different standards.
All these manual steps and equipment disparities can create tremendous potential for mistakes, and make changeovers and review times inefficient and lengthy. And they can result in gaps that can compromise your data integrity and complicate regulatory approvals.
How do you design your single-use manufacturing process for your long-term compliance and production needs? Consider these key elements:
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.
A standard equipment platform: When you use standardized instead of customized equipment, you help operators work more efficiently with a common interface. 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.
Automated data collection: Using a batch historian to automate your data collection will save time in the long run. It can also lower the likelihood of errors, and offer 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.
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.
By thinking long term about your single-use manufacturing, you can optimize your drug-development efforts today and accelerate product releases in the future.
Having the vision and planning to enable future possibilities takes a little effort in the initial stages but can pay off in huge dividends in the long run.
Top image courtesy of Mark Fletcher-Brown via Unsplash.com.