ImageForWithinOkay. I will start by admitting that this all began with a trip to the toilet. In my local pub.

I was busy chatting with friends about work and exactly what it is that I do, my industry does and how it actually links right back to their life. Compelling stuff you may say, especially after one or two beers.

During a quick visit to dispense some metabolites (after all, you are what you eat and you were what you excrete!), I noticed the sign shown in the picture and this got me thinking about Informatics. Bear with me.

Education Is Important?

Absolutely. I don’t want to detract from the fact that education is critical to the development of mankind in so many ways, but I also don’t want to get philosophical here. Anyone involved in science will have undoubtedly spent many hours in lessons, reading, researching, playing in the lab and repeating this ad infinitum. There are many developments in science that astound me on a daily basis, especially when you consider the amount of effort and dedication that so many people will have put into these developments. One such area is biopharmaceuticals.

Biopharmaceuticals Are Importanter…

shutterstock_237449059Those in the pharmaceuticals industry will not have been able to avoid the rapid growth of biopharmaceuticals, or biologics, with the FDA licensing 12 biologics last year alone. One thing that stands out is the cost of these biologics, and therefore the potentially large revenue streams that can be driven by these. Indeed, much like generics for ‘classical’ small molecule pharma drugs, there is a growing market to produce biosimilars or biobetters for any biologics that are nearing the end of their patent protection (there are estimates of CAGR 22.6% growth in the biosimilars market place) – potentially an easy way to tap into a vast amount of wealth some may say.

So, Why Is Education Important but Getting The Right Answers Is Importanter?

Whether you are creating a completely new biologic, or scrabbling to create that perfect biosimilar or even a biobetter, it is clear that a lot of hard work will go into this, from the research and development stages all the way through to production and the related QA/QC that goes along with it.

Provided that you get approval.

shutterstock_241636831Getting the right answer is important(er) when it comes to the analysis of your biologic. Throughout the whole process, ultra high performance liquid chromatography (UHPLC) combined with high resolution, accurate mass (HRAM) mass spectrometry is a technique that is commonly applied due to the highly reproducible LC separations and sensitive and accurate measurements afforded by the MS. Obviously there is more to it than this, but a huge part (or pain) comes when it is time to analyze all of the data that is produced, that is getting the right answer – the results.

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The characterization of biologics requires multiple different analyses to be performed. From intact mass analysis to peptide mapping – having a tool that allows you to take in all of this data and produce those all-important results with the minimal amount of effort is surely the elixir of data analysis?

Informatics, or software, should be there to make life easier rather than harder. It should free up time, allowing you to focus on the important part – putting that education to good use rather than sitting there performing tedious and repetitive tasks. Thankfully, the release of new informatics solutions allows scientists to take complex data sets when they are in the research and development stages and rapidly characterize these complex biologics, whether they are the latest blockbuster or biosimilar/biobetter.

But, don’t take my word for it.

 

Historically it took weeks to evaluate data, ruling out many false positives. For comparative quantitative modification analyses, we have gone from two weeks of analysis down to one day for multi-batch samples. 

– Guilong Charles Cheng, Alexion Pharmaceutical Inc.

 

And that was for the ‘hard’ part. When it comes to the paycheck end of biologics and you have the approval, you still need to ensure consistent quality in production. Informatics still has a place here in ensuring easy control of your systems and analysis of biologic quality!

There is also the back end! The bits hidden to a lot of scientists but sat there secretly helping them out, too. From laboratory information management systems (LIMS) through to data management, there is an informatics tool out there to help deal with all of those importanter results…

So, in a round-about way, my closing thought is that even in the pub toilets, science is all around us!