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Techniques & Tools Liquid Chromatography, Technology, Capillary Electrophoresis

Your Efficiency Challenge – Part II

sponsored by Agilent Technologies

Only 36 percent of respondents adopt the latest methodology and exploit state-of-the-art performance in LC. Lack of consideration or lack of foresight?

Udo Huber, Director LC Application Solutions, Agilent Technologies…

On analytical efficiency:

People started to think about analytical efficiency when Agilent introduced the first sub-2-micron columns in 2003 – kick-starting the UHPLC age. Suddenly, columns and instruments were available that allowed the same results with much shorter run times. However, although UHPLC can reduce run times to a few minutes, for many labs a more important benefit was the increased plate number or peak capacity. High peak capacity, especially in combination with orthogonal separation techniques like CE or SFC, gives scientists confidence that they are seeing all compounds in their samples, which is important for customers in all industries. Missing an unknown impurity in an API in the pharmaceutical industry, for example, could have a major impact on patient safety. Of course, detector sensitivity and dynamic range are also important aspects of analytical efficiency, but I think increased peak capacity is not only the biggest improvement so far, but also the area where major gains can still be made. The next step in this direction is 2D-LC, which gives peak capacities that can never be achieved by UHPLC.

On the survey result:

Does it surprise me that around a third of respondents use state-of-the-art methods? Yes and no. On one hand, increasing analytical efficiency should be beneficial for almost every analysis, whether it is increased peak capacity, better sensitivity, more dynamic detector range or lower carryover, to name a few. On the other hand, scientists cannot always make use of these possibilities because the method is validated and cannot be changed without significant effort for re-validation. Even for unregulated methods, scientists are reluctant to change a proven method. So, if there is no significant thread, like for example the acetonitrile shortage several years ago, scientists do not take the risk of changing methods or workflows.

Kelly Zhang, Principal Scientist, Genentech

On analytical efficiency:

To me and my team, analytical efficiency means the amount of useful information we can obtain per time unit, per mg of sample, per manpower, and per dollar (or put other way: efficiency = useful information/second/mg/person/$).

Efficiency is very important to us, as our goal is to deliver first-in-class and best-in-class medicines to patients in the shortest possible time.

In the case of liquid phase separations, there are many ways to gain analytical efficiency, with faster and universal methods, automation, and intelligent data analysis. When it comes to method speed, it’s not only how fast a method run time is, but also how fast one can develop that method. Method development can take significant time. Furthermore, to characterize one sample, many analytical instruments and methods may be needed, which significantly reduces analytical efficiency. One way we approach boosting analytical efficiency is by using multi-dimensional UHPLC with hyphenated universal detectors – with one sample injection, we can obtain information for multiple critical attributes.

On the survey result:

If you’re involved in research, you’re more likely to be in the quoted 36 percent – using the latest technology. But when it comes to the regulated environment of clinical drug development and the commercial stage, there is an inevitable delay in implementing the latest technology. For example, if you want to apply a new technology to drug analysis and file it in an IND or NDA dossier, there may be questions about whether the FDA will accept it, which could be considered a significant risk.

 

76 percent of laboratory analysts already work in a challenging multi-user, multi-method environment. Are your current processes and systems enabling smooth workflows?

Stéphane Dubant, Product Specialist  Liquid Chromatography, Agilent Technologies…

On instrument/software efficiency: 

Many analytical laboratories using LC are “service-providers” for internal or external customers. In this environment, it is critical to have the most efficient lab possible – and instrumentation and software efficiencies are an important contributor. Hardware features that give increased robustness or flexibility (broader use-range) to an instrument can have a significant difference in your day-to-day work. For example, dedicating a simple system to one application is ideal if you have a high volume of a single analysis, but if you keep changing methods all the time then column/solvent selection becomes an asset. Often, instrument downtime could be avoided by good laboratory practices.

Another thing we often hear about from customers is software inefficiency; in particular, the manual inputs required (for example, sample list parameters). There are tools, such as barcodes or LIMS interfaces that can speed up the process, but there is room for improvement.

On the survey result:

Companies are minimizing their footprints by having the same lab cover as many analytical aspects as possible (and outsource what is not possible or cost-effective to do internally). I expect that workload will continue to increase and staff numbers to decrease as these cost pressures intensify.

In the multi-user, multi-method environment, hiring the right people is paramount. Robust and simple instruments/software are important but the results are only as good as what you ask the instrument to do. I believe proper training on instrumentation, software and good laboratory practices can have a significant impact.

 

Laboratory management is considered a ‘service function’ by 50 percent of respondents. One in three laboratory managers already feel the threat of the competition – what about you?! 

Wolfgang Kreiss, Independent Consultant, Germany…

On laboratory efficiency:

When we think about laboratory efficiency, we tend to focus on speed (for example, number of analytical results per time) and costs (for example, number of analytical results per cost). For analytical projects, costs are closely related to the time taken, so the speed of analysis is a good indicator of the efficiency of an analytical lab. Even when increasing speed incurs greater expense, in my experience, the majority of customers will go for the faster analysis. Thus, for many laboratories, speed is the most important factor governing laboratory competitiveness.

Some laboratories are focused on improving quality criteria, such as sensitivity, precision or validity of the results; for example, in research environments. When it comes to assessing efficiency in such cases, laboratory managers can modify efficiency metrics by relating the numerical results for the quality criteria to their operational costs or the analysis time.

The Road to Improved Efficiency

Are you a scientist, laboratory analyst or lab manager – or all of the above? Are you willing to challenge your perception of efficiency or do you already know you need to make efficiency gains?

Join our experts – Kelly Zhang, Udo Huber, Stéphane Dubant, Adrian Dunn, Wolfgang Kreiss, Martin Hermsen and Oliver Rodewyk – for an exclusive series of video webinar masterclasses:

Webinar 1 – Analytical efficiency: How to push your results to the next level by selecting suitable technology

Webinar 2 – Instrument efficiency: How to survive the sample onslaught and even create a little breathing room

Webinar 3 – Laboratory efficiency: How to plan for success and secure your future

To register, visit: http://tas.txp.to/0918/YEC

On the survey result:

For day-to-day analyses that follow well defined workflows, lab management is a service function, but beyond such daily routine, laboratory management includes long-term planning and the shaping of a lab’s strategy. Successful lab strategies will depend on an appropriate understanding of the future development of technology and analytical instrumentation, as well as on the correct assessment of future customers’ requirements. In my experience, most lab managers today are feeling the pressure of competition, so developing adequate strategies will be crucial for the long-term success of their laboratories.

Oliver Rodewyk, Account Manager Strategic Accounts, Agilent Technologies...

On laboratory efficiency:

Cost-saving initiatives are the typical starting points for lab efficiency projects, but there is never a one-size-fits-all solution, taking into account equipment usage, know-how, transition plan and flexibility to new techniques as well as budgetary plan. Rather than cost-saving, the more forward-looking approach is to concentrate on cost-effectiveness. A lab manager can only boost efficiency if they understand four key issues:  the workflow dependencies in the lab, utilization of equipment, target service level and lifecycle management.

On the survey result:

“Service” is linked to cost, systems are linked to investments. Lab management includes the whole lifecycle, not just of equipment and services but of the whole lab.

Utilization and flexibility of adapting new requirements or techniques must be combined with a clear view for the next 3–5 years. Lab managers must regularly ask themselves:

  • Is this technique or equipment an opportunity or a burden?
  • Is my sample throughput fixed for upcoming years?
  • How will my lab handle changes?
  • Should any aspect be outsourced?
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