Coming from a small molecule background, biotherapeutics just don’t interest me. Not one bit. They are big, a pain to analyse and it’s bothersome to listen to the struggles faced by those working with them.
That’s how I used to think.
Biotherapeutics are great, almost magical!
It’s easy to dismiss things when they are outside your comfort zone, but over the past 5 years I’ve become increasingly familiar with these powerful and promising ‘giants’ – to the point where I have a secret admiration for them, those that work in this field and the technology behind their development and analysis.
There goes my secret.
Whilst small molecules will continue to play a large part in many peoples’ lives, biotherapeutics offer the chance for many with so-called ‘rare diseases’ to live longer and improved lives; from post-chemotherapy to auto-immune disease and certain cancers, biologic therapies can deliver hope.
Getting these through the drug development pipeline to the market is not cheap, fast or easy. There is a lot to consider. Even two specific analyses that have to be performed throughout this development pipeline, i.e. Charge Variant and Aggregate analyses, can traditionally take time to develop, refine and pass through to final QA/QC and lot release testing.
Now I’m still learning about what goes into Charge Variant and Aggregate analyses, but I do know that researchers from the National Institute of Bioprocess Research and Training ﴾NIBRT﴿ in Dublin, Ireland, along with our own scientists have been advancing these fields greatly.
With new workflow kits, charge variant profiling can be simplified and streamlined to deliver significant improvements in reproducibility, method transfer and ultimately the amount of time taken to perform (Check out the image where infliximab’s charge variants are being separated in around a minute! Not only is this crazy fast, it is highly reproducible and something that even I’d be able to perform in the lab).
Like what you are learning?
Learn how pH gradient buffer kits enable you to easily produce linear pH gradients for fast and robust therapeutic protein separations in this informative animation – you may even spot someone that you know!
If this sounds too good to be true, sign-up for two educational webcasts with experts from both NIBRT and Thermo Fisher Scientific to find out how you could be realizing these results in your laboratory.
Now that I’m a reformed character and less bigoted in my views, I’m all for the learning! The advancement in Charge Variant analyses is impressive, but it doesn’t stop there – NIBRT have gone one step further in developing a universal method for mAb aggregates analysis too.
The benefits of a single method with the required resolution necessary are clear: no method development requirements, rapid screening of mAbs in the early discovery phases, and simplified transfer of methodologies through to QA/QC.
The nice thing about these educational webcasts won’t just be the science behind these great results, they will also look at the importance of column selection, instrument choices and proper set-up of your UHPLC systems so that you can really get the best out of your system for protein analyses.
What have you got to lose? I challenge you to try and be bored with biotherapeutics and these advancements.