Method development and validation procedures are usually the work of a few specialists within a laboratory. The specialists possess the understanding and have the time to undertake such work. The specialists are a fountain of knowledge and they are a bottle neck. At ADKL Labs we recommend sharing experience widely and encourage continuous improvement approaches with our training packages. Method development is critical in cultivating analysts with valuable qualities, such as:

• Understanding your instrument(s)
  • Every instrument has quirks, limitations, strengths and the only way to find them is to go looking
• Origins of reporting / method requirements
  • Why do we monitor that QC/ISTD abundance? How does it relate to the rest of the analytes? Where did these criteria come from?
• Recognising chemistry within the entire workflow
  • Everything from how the sample is receive to the time of day your data is acquired can impact data quality

The experience gained by an analyst undertaking method development is not limited to that specific method, application, instrument or software. Consider the widely available chromatography mass-spectrometry systems (LC/MS and GC/MS) on the market. At ADKL Labs the observations and experience gained during method development are often directly translatable across analyses, systems and even platforms. During development work, analysts learn the limitations of their instrument then observe “trends” affecting the quality of their data. While many trend visualisation tools exist, observing the changes in system performance for yourself, applying a solution, then recording the change is worth a thousand trend charts.

The value in method development is created when the analyst drives their own troubleshooting and recognises the same approach(es) apply elsewhere. There are countless areas for improvement and efficiencies that cannot be realised without active participation. For example, the below areas are commonly encountered:

1. Pre-empting the need to clean an ion source. Recognising implications of QC and ISTD fluctuations will avoid unnecessary down time later. In this case the SOP may benefit from an update.
2. Recognising that overlooked inlet activity was the source of chromatographic degradation on a GC/MS can avoid sample re-runs later. Investigating appropriateness of consumables and/or QCs might be worthwhile here.
3. Discovering a faster way to view and process results during data analysis can save many hours over a short period. Every analyst will have their own preferences for data review and needs to experiment to discover them.

Experience with method development takes time, specifically instrument, sample prep. and bench time. However, we can adopt proactive strategies to spread experience among the team(s), so they don’t have to learn it the hard way. At ADKL Labs we focus our approach and training packages on three areas:

1. Refresher training– regular knowledge-gap analysis ensures fundamental principles are understood and applied. Basic theory is just as important as practical experience to ensure data is interpreted rapidly and correctly.
2. Fit for purpose QC – instrument and application-specific considerations will change over time and need to be recognised and updated accordingly.
3. Continuous improvement principles – instrument and consumables vendors constantly update their products. Areas for improvement can be method related, sample preparation, changes in technology, resource allocation, new training, or simply just practice to better use what’s already available.

At ADKL Labs we enthusiastically develop training material(s) focused on gas and liquid chromatography, with and without mass spectrometry. After establishing a foundation in the theory and practical aspects of the technology we can better explore and understand method development approaches and processes. Please contact ADKL Labs if you have any enquiries, feedback or would like to share your ideas.

Note: The views and opinions expressed herein are those of the author and do not necessarily reflect the official position of ADKL Labs.