Eurotherm helps with data acquisition at the drug development stage and with data analysis and therefore process understanding at the next stage
Improved quality and reduced costs are two of the main driving forces behind the life sciences industry today.
This is especially true for the biotechnology and pharmaceutical sectors.
To a large extent, these forces are being driven by regulation, which is now one of the industry's major costs.
However, regulators such as the US Food and Drug Administration (FDA) and the Medicines Health Regulatory Agency (MHRA) are keen to reduce their cost burden by making manufacturers themselves focus more closely on improved product quality.
The idea behind such a self-regulating regime is that it would both improve product quality and reduce the need for - and therefore the cost of - intervention by a regulator.
Although self-regulation has proved less than successful in some industries, in others it has led to substantial cost savings as a result of improved product quality and faster delivery.
This should certainly be the case for the life sciences industry too.
However, it is important to remember that a regulator's first priority is patient health.
So manufacturers have to demonstrate in the first instance that they thoroughly understand their manufacturing processes and that they know how to minimise the risk involved with them.
The regulator is looking for terminology such as 'risk-based approach' to demonstrate that company's quality systems embody forward thinking techniques for continuous improvement.
A science-based approach founded on a total understanding of the science that underpins the manufacturing process supports manufacturer's claim to be in control of their risks and processes.
It also shows that such understanding is being applied to quality systems by using standard procedures in risk management in order to achieve the very best product quality.
Many companies are now coming to realise that their level of regulation has increased over the years simply because, in the past, they have not been able to demonstrate this deep understanding of their processes to the regulator.
On the other hand, companies that by sheer determination have achieved such understanding are finding that they can reduce the number or intensity of regulatory inspections and the number of quality systems they need - therefore reducing costs.
The new approach.
Most life science companies follow a classic product life cycle that starts with drug discovery and ends with plant decommissioning.
They have been making products this way for many years.
However, there is a growing emphasis on the need to better understand all aspects of new product development.
Firstly, manufacturers now learn as much as possible about the science of making a new drug.
Although this stage still uses traditional analytical techniques, it is making far greater use of new technologies and instrumentation.
This means that product manufacture can be understood right down to the atomic level.
Importantly, it also helps scientists to understand the critical control points.
These are routinely being used by both the oil and food industries to ensure that processes can be accurately repeated time after time.
Such critical control points are particularly relevant to the life sciences industry as you move from laboratory-scale production to full-scale production.
The process dynamics change at each stage and in the past a procedural-based system was followed until the product was manufactured the same way three times.
This was then adopted as the procedure for manufacturing that product.
A science-based approach ensures that when these critical control points are achieved, the manufacturer knows that it is in full control of its process.
Success here depends to a large extent on data acquisition.
The scientist knows what measurements to take and what variables to measure, so basically the laboratory is brought down to the production department to measure them in-line and also to do control in-line.
Once the in-line measurements have been taken, advanced process control tools and analysis tools can be used to understand correlations between process elements and interactions at the molecular or biological level.
By understanding this and by looking for mathematical correlations, predictions can be made as to what happens during the process.
The software used here is based on statistical process control, and spectral analysis.
It takes all the uni-variant data such as temperature, pressure and flow, along with the multi-variant data such as frequency and mass spectrometry and puts them into a big mathematical engine that looks for correlations against set process points.
It is at this point that Eurotherm's technical expertise really comes into play.
Its technology does two things - extremely accurate measurement and database manipulation.
This is exactly the same procedure as carried out by the oil and food sectors for many years.
However, it has not been adopted by the life sciences industry because traditionally the regulator has insisted on a procedural-based approach to manufacturing.
This has now changed.
Some would say the change is consumers lead and that they have pressured the regulator for lower costs and higher quality and they have accepted that its 'stick to procedures' approach stifles innovation and promotes inefficiency while not necessarily guaranteeing quality.
Spend to save.
In one sense, cost savings are only marginal with this approach.
Obviously there is an increased cost at the front end, but you are achieving quality by design.
By making sure of quality at the front end, however, it also ensures quality at the back end in terms of less wastage and less product variability.
So companies do save money.
Also, it is worth bearing in mind that with a new drug costing anything from £200m to £1b to develop, the cost of this equipment and therefore the cost of understanding the process is a fraction of that.
Of course the instruments and analysis tools can be reused for the development of many other new drugs, too.
The other important aspect to consider is the message that this approach sends out to the regulator.
Effectively users are saying, "Look, I understand how to make my product and I can reproduce it very accurately.
"There is also a risk-based approach to what I do in manufacturing, so you don't need to police me too much".
Nevertheless, such an approach does not signal the end of 21CFR Part 11: companies will still adhere to good automation and manufacturing practices.
It will be inherent in their quality systems.
But what it does do is give them latitude to change the process without reference to the regulator.
Once the process is understood, the loop can be closed by taking the same measurement and analysis technology from the laboratory and deploying it on the production line in order to do in-line control on new measurement techniques.
This is a new and better method of control for the life sciences industry.
Eurotherm is a supplier of control, measurement and data recording solutions and services to industrial and process customers.
The company's international reputation as a provider of innovative solutions across a broad spectrum of vertical markets is supported by engineering services designed to realise greater benefits to customers' plant-wide assets.
Eurotherm's product range includes distributed process automation systems and machine control incorporating single and multi loop control, operator displays, data management and graphic recorders, power control and signal conditioning.
It is an ISO9000 approved company, and operates TickIT protocols for software management.
