Over at the ISA Interchange blog is a post, Part 2: Integrating Analyzers with Automation Systems in Life Sciences. It points to a post by Emerson Exchange 365 community member Greg McMillan from last year, Top Ten Limitations – Analyzers.
In the blog post, Greg is quoted:
The biopharmaceutical industry is expanding their ability to analyze batch profiles online. In mammalian cell bioreactors a dielectric spectroscopy probe is used as an online analyzer to measure viable cell concentration and glutamine besides glucose addition is scheduled. Flexible at-line analyzers using electrochemistry, digital imaging, freezing point depression, and photometry (e.g. Nova BioProfile FLEX) can measure in 2-8 minutes cell density, cell diameter, cell viability, osmolality, substrates (glucose and glutamine), and many byproducts such as carbon dioxide, lactate, and ammonia that inhibit growth and product formation. Near Infrared (NIR) spectroscopy can be used to provide online measurements of substrate, byproduct, and product concentrations. Mass spectrometers can measure the amount of oxygen and carbon dioxide in the bioreactor off-gas for oxygen uptake rate and carbon dioxide production rate calculations.
The post has an embedded ISA Slideshare presentation by Joseph George from Genentech, Integrating Analyzers with Automation Systems for Real time Control.
The post concludes:
As scientists realize their increased productivity and access to data to compare experiments across labs, more life science plants are looking for real-time integration of analyzers in their processes... More discussions on process analyzers will be taking place at the Automation Week 2012 in the Control Performance Track.
What ways are you integrating analyzers into your process?
ThThanks for the link to Greg’s post. This is in line with the FDA's push for innovation and real time quality control in order to manage product quality. In biologics this is of critical importance as the batch to batch variability tends to be greater. I would expect that on line measurements will eventually tie into to real time control and ultimately increased product quality, the principle behind PAT.
Right now most of the analyzers are used in the labs (R&D) and we are seeing a movement to the manufacturing floor. One of challenges however is the manufacturing floor needs ruggedized equipment and common interfaces in order to tie into control systems. So far this has been haphazard and not a strong consideration from the instrument vendors.