Biopharmaceutical Witchcraft and Wizardry at MiBio 2012

Eye of newt…

I’d like to take this opportunity to introduce myself: I’m Lisa Newey-Keane – brand new Biopharmaceutical Product Manager at Malvern Instruments.  I say “brand new”, but I’ve been working away feverishly behind the scenes for a couple of months already.

Over the years, most of my experience has been gained in the contract manufacturing and research industries.  From a first degree in Marine Biology I progressed to a PhD in Microbiology and Protein Chemistry, then spent a few years at Lonza and Novozymes, where I used mass spectrometry amongst other tools to characterize biopharmaceuticals and excipient proteins.

Toe of frog…

Finally escaping the lab, I moved to Shimadzu and on to Quotient Bioresearch where I helped develop Quotient’s bioanalytical services for preclinical and early clinical studies, primarily for antimicrobials.  I have always gravitated towards therapeutic proteins, particularly monoclonal antibodies, and have watched with interest over the past decade or so as biopharmaceuticals have risen to the forefront of therapeutic research and development.  So it was with delight back in September that I joined the product management team, and I now spend my time helping to develop, guide and promote Malvern’s excellent range of protein characterization instruments.

Wool of bat…

No stranger to the world of proteins, Malvern is well aware of this transformation within the pharmaceutical industry and has developed a range of instruments designed to support scientists working with proteins, including the Zetasizer Nano ZSP, Viscotek systems, the early access program Viscosizer 200, and the newly-launched Archimedes.  You can learn more about these systems and how they can help elucidate and quantify the aggregation of proteins here.

And Tongue of Dog!

On 30th October (Hallowe’en eve, as I like to call it!) I travelled over to my old stomping ground of Cambridge for MiBio 2012, a one-day meeting focused on stability issues in biopharmaceutical formulations: a real “Witches’ Brew” of denaturation and aggregation problems.  We presented a poster on the Diffusion Barrier technique used with the Zetasizer Nano ZSP; this method helps minimalize sample size – a real boon in the world of biopharmaceuticals – and also helps avoid protein aggregation by preventing sample-electrode contact.  We displayed the ZSP in a focused exhibition and provided information on Malvern’s range of instruments which are used to detect and quantify protein aggregation.

Double, double toil and trouble; Fire burn and cauldron bubble…

We were delighted to have the opportunity to speak with so many outstanding researchers about the issues and limitations they face in their everyday analyses, and to be able to present potential solutions to them.  The star of the day was Archimedes, a truly novel instrument based on the principle of resonant mass measurement, with the ability to count and size particles, including protein aggregates, in the diameter range 50nm – 5µm, perfectly filling the gap between GPC/SEC and optical techniques, and providing invaluable information on aggregates of sizes identified by the FDA as a real cause for concern in immunogenicity in biopharmaceutical formulations.  You can read more about Archimedes and how it works here.

I look forward to bringing you lots more information on all of Malvern’s protein characterization tools and their applications over the coming months, and of course keeping you posted on where we travel to next!

Please do get in touch if you’d like to know more about our “Biopharma” instruments – I promise not to bite (as long as it’s not a full moon!)