April 15, 2017 (Vol. 37, No. 8)
Platform Approach Integrates Multiple Technologies for a Variety of Applications
At the recent Interphex Conference in New York City, Thermo Fisher Scientific officials pointed out that it is increasingly focusing on modular automation technologies to assist companies in their drug discovery, R&D, and biomanufacturing activities.
GEN interviewed Dirk Tillich, vice president, global sales, Finesse, a part of Thermo Fisher Scientific, to find out more about Thermo Fisher’s strategy for relying on modular automation.
GEN: What does modular automation mean to Thermo Fisher?
Mr. Tillich: The ability to use modular automation increases the usage rate of the process equipment and cleanroom space. Utilization is one of the key elements to reduce the cost of goods and increase competitiveness.
GEN: What are the main benefits of using modular automation technology for the laboratory production line?
Mr. Tillich: In a complex matrix of competitors, including those focusing on originators and biosimilars, or when you think about the vaccine market, with sporadic market demands, it becomes a strategic decision to be prepared for rapid changes in R&D or production. Process formats and volumes are varying, sometimes unpredictable. Additional or fewer process steps, higher or lower volumes need to be handled, in a GMP-compliant manner.
As the down time and modification cost need to be low, modular automation is the right answer because it can provide the flexibility required for those varying circumstances.
GEN: Can you give one or two examples of Thermo Fisher’s hardware and software in the biomanufacturing arena that illustrates this concept of modular automation and how this improves the bioproduction process?
Mr. Tillich: The acquisition of Finesse allows Thermo Fisher to extend the supply of best-in-class bioprocessing vessels, such as the new HyPerforma 2000 L Single-Use Bioreactor with a turn-down-ratio of 5:1 or the 5000 L imPULSE Single-Use Mixers, by a highly configurable, scalable, modular Finesse control system.
Finesse’s TruBio® control software and the control hardware are designed to fit the industry’s needs for an off-the-shelf solution that enables a solid but quick validation, easy to adopt process control strategies, and the flexibility to swap process equipment in size or type. The DeltaV®-based IT backbone secures the data integrity while the Finesse SmartParts enable the flexibility and control precision.
As an example, the G3Lab Universal Controller can run Finesse’s small-scale disposable 3 L SmartVessels, Finesse glass, or other brand’s vessels. Also, the SmartRocker or even a 250 L HyPerforma SUB can be perfectly controlled by the same unit. It combines a series of SmartParts [i.e., the TruFlow master flow controller (MFC) manifold] to become a universal controller and communicates with the TruBio software.
If a TruFlow unit gets replaced by one for higher flow rates, TruBio will automatically recognize the new number of MFCs, gas types, and flowrates. This software-supported hardware modularity improves process control, product yield, and quality.
GEN: How did the acquisition of Finesse by Thermo Fisher in February increase your modular automation capabilities?
Mr. Tillich: Before Thermo Fisher acquired Finesse Solutions, we had superior products for nearly every area of the workflow such as single-use, cell culture, purification, and even Pharma analytics products. Now, Thermo Fisher is are able to provide those products to our customers in an open architecture format, and automate the process. This provides an unparalleled level of flexibility and automation not previously available.
GEN: Briefly describe the key technologies required in today’s bioproduction workflow and how the Finesse components help tie together the entire process.
Mr. Tillich: The key technologies are: bioreactors, bioprocess containers, media, filters, chromatography resins, and the skids/automation that enable their automated use.
Finesse provides the controllers and software for running these skids, and is developing these skids. Finesse also allows the data from the workflow and third-party analytics to be collected in one repository and analyzed for process optimization.
Essentially, Finesse provides the binding layer for the workflow process control and data management, leading to improved productivity in cGMP production and faster scale-up from R&D through production.