By Jeremy Bezaire, Product Manager, Cytiva
The biopharmaceutical market is growing rapidly, and improved bioprocessing techniques are necessary to reduce manufacturing costs and get your product to market fast. Obtaining FDA approval for your product depends considerably on whether you can guarantee quality control and consistency in your manufacturing process. This has led to the development of new technologies aimed at ensuring the stability, reproducibility and quality of biologic drug products, while keeping bioprocessing costs low.
Stability and reproducibility of your product can be improved by automating your entire manufacturing process. Automation limits manual interaction during bioprocessing, resulting in greater accuracy, greater efficiency, lower costs and a faster time to market for your biologic drug product. Deciding which automation system is the most suitable for your facility will depend on your current equipment and biomanufacturing processes, and how much you plan to grow in the future. Options run from equipment-level automation to a fully comprehensive distributed control system (DCS). The Cytiva Figurate™ automation solution powered by DeltaV™ is designed not only to integrate with your current equipment but to also grow with your company’s needs. Figurate powered by Delta V simplifies engineering management, improves data management, reduces process risk, and increases the consistency of your product.
Expertise is key to DCS installation
Emerson’s DeltaV is a leading DCS in the biomanufacturing industry and has a strong reputation that is backed up by comprehensive capabilities. However, the full value of an investment in Emerson’s DeltaV is reliant on how it is implemented. For this implementation, the industry has traditionally relied on third-party system integrators that often do not possess knowledge about the specific needs in a bioprocessing workflow, nor have firsthand expertise in the equipment for which they are integrating with the DeltaV system. A custom installation such as this comes with risk as well as a significant resource burden on top of an already significant infrastructure investment. Choosing a vendor with both bioprocessing and automation knowledge to design and implement your system can save time, save money, and ensure a system that is built with your current and future needs in mind.
Recognizing the benefit of a solution designed specifically for the biomanufacturing industry, Cytiva developed Figurate automation, a product portfolio of automation platform solutions that includes one powered by the reliability of the Emerson’s DeltaV.
Figurate automation: improving operational productivity while reducing risks
Cytiva’s Figurate automation for DeltaV is a software product that applies Cytiva’s process and equipment expertise to the Emerson DeltaV platform. The solution is based on the DeltaV PCSD library, which was developed by the Emerson Project Management Office as a Configuration Standard for DeltaV. By pairing Cytiva’s process equipment with an automation solution that is built for purpose, you can unlock the most value from your investment.
Additionally, Figurate automation follows industry and platform conventions for design, so it offers a consistent look and feel to many other applications of DeltaV within industry. This means operations staff and engineers accustomed to DeltaV functionality maintain familiarity with the system, ensuring standard features and operation of equipment across company sites and across projects. This consistency with industry design trends can reduce training for operations staff as well as the learning curve for internal engineering staff.
Figurate automation may also facilitate the harmonization of process transfer documentation, operating procedures, and manufacturing procedures by using standardized parameter naming and sequential operation. For example, if a manufacturer is executing a tech transfer from a development site to a manufacturing site, they may use the same control system platform but not the same database. Using Figurate automation allows structure and alignment within the database and provides traceability as the software changes, ultimately streamlining the tech transfer process. Aligned equipment and software gives you the ability to move staff between facilities with minimal impact on productivity, offering better leverage of subject matter experts (SMEs) throughout a company’s network, both in person and remotely. Operating capacity can be improved as well by eliminating the dependency of a product process on the particular “flavor” of automation or equipment on which it was initially developed. Therefore, if automation is the same at all facilities, it does not matter where the next step of process development is executed.
As your company grows, you must be able to add technology to and around your process equipment and control system over time, which is why Figurate automation for DeltaV is built and delivered with an open software architecture. Software can be applied to a single-unit operation or to an entire facility, but also be expanded to other applications at the pace your business moves. In cases where your existing techniques and technology are not supported by the Figurate automation product, Cytiva’s experts can adapt it to fit your needs.
Faster project execution with an automated system built for the future of biomanufacturing
Speed to market is critical in today’s increasingly competitive industry, which is why the Figurate automation solution can be especially beneficial in the race to market, by reducing the increased time and costs often associated with customized solutions. One of the steps that can add time to system development is verification. Figurate automation is designed and verified using GAMP5 methodology, is compliant with ISO9001, and is delivered with a verification documentation package significantly reducing the time typically needed for these activities. While some customization may be required to accommodate your specific needs, the time between purchase order and production runs is drastically shortened because most of the design and verification work has already been completed during the Figurate automation product development.
By implementing a predefined system, you can take software development and verification off the critical path, reducing your dependency on valuable internal process automation resources for design reviews and minimizing contingency with the knowledge that change orders will be far less frequent. The overall price of Figurate automation is lower than a customized solution since the cost of engineering efforts is already included in the price of the system, rather than incurring engineering costs on each project. Figurate automation offers you the opportunity to contribute to increasing speed to market and lowering the total cost of ownership over the life cycle of your automation software. In the end, leveraging a solution that includes this wide range of benefits along with support from a trusted vendor like Cytiva can give you confidence that you are using a system built for the existing needs of bioprocessing and automation today and well into the future.