Manufacturing: Exceptional Results Through Deep Process Understanding

The global market for therapeutic proteins and monoclonal antibodies, in addition to the worldwide demand for new biomass production and biotechnology-based manufacturing processes for cosmetics, foods and animal feed is on the rise. At the same time, the demand for corresponding manufacturing capacity and quality is growing as well. In this environment, DASGIP process analysis modules are particularly well-suited for managing on-going production processes with the help of specific process information when performing tasks such as off-gas analysis or optical density monitoring.

DASGIP modules can be integrated in external manufacturing and centralized process control systems thanks to a modular design and OPC interfaces, thus permitting the online monitoring of production-specific parameters. An increasing number of customers are deploying DASGIP modules, such as the mass flow controlled gas mixing station, as part of their GMP manufacturing facilities.

By having an in-depth understanding of the process itself, which creates an optimized manufacturing platform, the deployment of process analysis technologies in manufacturing is consistent with the FDA PAT Initiative. Process monitoring is a vital element of manufacturing quality assurance, for which DASGIP offers additional solutions.

Single Use Bioreactors / S.U.B.

The Thermo Scientific HyClone single-use bioreactor combines the advantages of disposable bioreactor technologies such as ease-of-use, the elimination of cleaning procedures or the exclusion of cross contamination, with traditional and therefore proven stirred tank technologies. The DASGIP control system can be easily combined with Thermo Scientific HyClone Single-Use Bioreactors (HyClone S.U.B.). The mass flow controlled MX4/1 gas mixing system, the precision controlled MP4 multipump module and the PHPO monitoring module for conducting pH and dissolved oxygen measurements are all proven components of the DASGIP control system. Through seamless integration of the Thermo Scientific HyClone speed and temperature control in the DASGIP control system, including reference and actual values, users can continue to take advantage of the valued benefits of the DASGIP software in the same familiar manner. While DASGIP bioreactor systems for cell cultivation support working volumes ranging from 30 milliliters to 5 liters, the integration of the Thermo Scientific HyClone S.U.B. permits pilot scale working volumes of 50 liters, 250 liters and higher. The availability of consistent control mechanisms, with respect to both hardware and software, thus represents a significant advantage.

» E-Flyer HyClone S.U.B. (PDF)

» more about DASGIP control of disposable bioreactors

DASGIP supports

DASGIP supports