Automated Process Control for the Development Laboratory - - BioPharm International


Automated Process Control for the Development Laboratory

BioPharm International
Volume 19, Issue 3


The benefits of a comprehensive, automated process control and data management system make a long list (Table 2), but they all lead directly to the main points of greater efficiency and shorter time-to-market. Almost all modern instruments are designed with the capability to communicate and cooperate, but what has been lacking is the orchestra conductor that manages and controls all the individual instruments as a unified whole. The software working at the process level bridges the gaps between disparate subsystems. It is independent of the instrumentation and able to communicate with instruments of all brands. It supports all types of physical connections: Ethernet, serial, analog & digital I/O, OPC, and other standard protocols.

Another benefit that comes from device-independence is that one method of measurement can be replaced with a new one, with no interruption to the history of the process value. Here, the phone companies set a good example. A customer can buy a new phone (instrument), but his phone number doesn't change; his identity stays the same. Likewise, when an old mass spectrometer is replaced with a new kind of gas analyzer, the nitrogen measurement has a seamless history across the two.

Figure 3. Unified data from instruments, offline measurements, and results are all visible on the computer screen.
Even with the wide spectrum of open instrument communication, there might still be some external analyses from which data is collected by hand. This "off-line" data can be entered into the unified data management system and is treated as an equal citizen. It is available for display, analysis, and feedback control, along with all the data from the various instruments that were automatically collected. Also, all online data analysis or calculated results are equally available for display, further analysis, and feedback control. Figure 3 shows a Trends display that graphs process data acquired from online instruments, off-line measurements, and calculated results all together.

Figure 4. A networked, distributed system can connect to other parts of the system.
In addition to communication with each different data island, there need to be bridges between the islands. This is accomplished by a distributed architecture, linking all computers, instruments, data servers and archives. This requires a robust network to be in place. A company's IT group has to be an active player here, and should be involved early in the planning. Figure 4 shows examples of connections in this distributed system.

The advantages of a distributed system are many. First, all aspects of the process control and data management can be available from any site on the network. A technician can monitor many reactors from one station, or respond to alarms remotely. A researcher can check on and adjust experiments from her office, create reports, and be automatically notified by email or pager when problems arise. Second, instrument resources can be shared. One expensive gas analyzer can serve many reactors. Third, know-how and results can be shared. A recipe or control strategy developed by one scientist can be used by others for scale-up or for other runs. Process data and results can be shared and compared on a live system, even from a meeting room. The Operations Manager of a San Francisco Bay Area biotechnology firm said, "I have immediate access to all the reactors I manage in three separate facilities, and this has streamlined our post-experiment data analysis."

blog comments powered by Disqus



Bristol-Myers Squibb and Five Prime Therapeutics Collaborate on Development of Immunomodulator
November 26, 2014
Merck Enters into Licensing Agreement with NewLink for Investigational Ebola Vaccine
November 25, 2014
FDA Extends Review of Novartis' Investigational Compound for Multiple Myeloma
November 25, 2014
AstraZeneca Expands Biologics Manufacturing in Maryland
November 25, 2014
GSK Leads Big Pharma in Making Its Medicines Accessible
November 24, 2014
Author Guidelines
Source: BioPharm International,
Click here