To reduce scale-up costs and facility capital expenses, many biotechnology companies are transitioning their stainless steel infrastructure to single-use or disposable systems. As single-use bioreactors have matured, their market acceptance has rapidly expanded. The move to disposables is in many instances driven by reduction in sterilization and cleaning requirements, improved plant flexibility for multiproduct manufacturing, reduced product changeover costs, and faster time to market for new products. To fully enable the single-use paradigm, the automation software, hardware, and single-use sensors must be designed specifically for this application; moreover, both validation documents and leachables/extractables certifications must be readily available for cGMP implementations.

Turn-Key Solutions

Finesse provides turn-key, configure-to-order measurement and automation solutions for both single-use bioreactor types: “rocker” (e.g., GE/Wave) and “stirred-tank” (e.g., Thermo Scientific/HyClone) systems. The Finesse turn-key system is optimized for each bioreactor type and can achieve optimal growth and product formation by the organism present in the growth medium. These systems are based on the DeltaV automation platform from Emerson and are scalable from R&D to process development to cGMP manufacturing. Finesse provides full support for its systems including installation, training, validation packages (FAT, SAT, IQ/OQ), as well as service and maintenance programs.

Finesse offers disposable sensors for dissolved oxygen (TruFluor DO), pH (TruFluor pH), temperature (included in both TruFluor DO and pH), and pressure (TruTorr), all of which are preinserted into a single-use bioreactor bag and gamma irradiated with it so the entire system will arrive sterile, and the time from unpacking the bag to inoculation is minimized. Finesse sensors have embedded gamma-radiation–resistant “smart chips” that contain the relevant calibration parameters and minimize operator time during process set-up. The disposable sensor performance exceeds that of electrochemical sensors in noise and time response without sacrificing reliability or precision. The unique, patented sensor design eliminates the long-term drift issues observed with fiber-optic–based fluorometric systems.

Automation hardware systems used with disposable bioreactors must be flexible to adapt to the different processes that can be run in a multiproduct facility. The Finesse TruViu hardware product family is user-friendly and plug-and-play with a wide variety of external equipment such as pumps, scales, and off-line analyzers. Finesse equipment has a modular design, allowing fast and easy reconfiguration of a bioreactor train for different bioreactor sizes and types as well as different processes (batch, fed-batch, perfusion) or cell lines.

Automation software should allow rapid scalability of a process through advanced process models and smart algorithms as well as ease of data collection and analysis. Finesse TruBio software has been developed with GAMP4 methods and validated for cGMP applications. TruBio DV software allows easy process reconfiguration through drop-down menus without DeltaV programming and allows users to save and load process recipes for accelerated process scale-up or transfer. TruBio DV software can be used with glass vessels and most types of single-use rocker or stirred-tank bioreactors to provide a seamless integrated solution from R&D through production.

Serving the New Paradigm

As more companies involved in bioprocessing realize that they can scale their ideas into clinical production but choose to outsource their manufacturing, their automation systems must also allow for process technology transfer between different facilities and types of reactors. As the average titer (expressed as grams of product per liter of culture) produced continues to increase, the size of bioreactor vessels required in manufacturing will decrease; this trend will further accelerate the transition to disposable bioreactors in production environments. With the adoption of fully disposable facilities, the advent of scalable bioprocesses from research through GMP manufacturing is imminent. Finesse’s mission is to serve this new market paradigm with turn-key, configure-to-order, single-use bioreactor systems.