Highlights of something new | v2017.1 of ACD/Spectrus Software
AAPS 2017: Applying QbD in Process and Impurity Control Strategy Development

Chromatography Musings

Gabriela Cimpan, Senior Director Sales, Europe 

Image001There comes a time when one looks back at their career and questions why it took the path it took. What was the most influential decision or choice that made it possible? I should say that my parents played a big role and their decision to move their young family including me, a 6 month old baby, to a city renowned as an intellectual powerhouse with 5 large universities, laid the foundation for a world class education.

My scientific background in chromatography and my further career choices, however, were definitely influenced by Professor Simion Gocan from Babes-Bolyai University in Cluj-Napoca, Romania, one of the largest in the country and with a very good reputation worldwide. Professor Gocan was a true scientist, paying attention to detail and discovering relationships where no one else could see them. He was also a passionate teacher who conveyed his thinking and scientific standards to many generations of chemistry students and Ph.D. graduates.

I was lucky to start my academic career under his guidance, uncovering the mysterious world of chromatography and learning about its limitless power to separate complex mixtures. It also opened perspectives worldwide, through scientific collaborations. Suddenly I had access to connections everywhere, to people who thought like me, like us. Professor Gocan was published everywhere, he was a member of many scientific organisations, including the Chromatographic Society in the UK. Many of my students, from my brief graduate teaching stint, have successful careers across the globe, from the USA and Canada to Europe and Australia.

My career has moved from academia to business, but I’m still lucky enough to use my technical background in a competitive business environment, and apply the sound principles of ‘learn, do, teach’, when I want to make sure something is well understood. There is no better learning method than preparing yourself to teach someone else.

Recently I had the honour to be invited as a speaker to a scientific meeting organised in the memory of Professor Gocan. It created an opportunity for reflection at a personal level, but also about chromatography, about how this world has changed over the last 30 years.

Chromatography can take many forms, but all of them follow the same principle of compounds having different affinity between 2 immiscible phases, partitioning differently between them, and as a consequence moving with different speeds through this medium, resulting in separation after a certain time. This is the simple, yet so complex, mechanism behind separating complex mixtures. The process of separation is necessary to isolate, identify, and characterize compounds, and has applications in almost every field dealing with compounds and substances.

In liquid chromatography, from paper and thin layer chromatography, to complex HPLC/UPLC instrumentation with UV and MS detection, the fundamental principles and the theoretical algorithms of separation are the same for identical or similar stationary and mobile phases. Once the theory behind a complex process is understood and there are algorithms, it brings enormous power to technological advances, allowing increased efficiency and miniaturization, hence the separation and characterization of smaller and smaller samples. We are pushing the boundaries of what can be separated by chromatography.

Chromatography was and still is a research tool. It is also becoming a commodity with more and more outsourcing. If you look at the complex environment of impurity separation, identification, and characterization in the pharmaceutical world, chromatography is essential. Chromatography is crucial to enabling the separation of the API from all other substances. A robust chromatographic method is developed and used from early development through manufacturing to monitor for consistent quality of batches of material and in the worst case scenario, to help isolate and identify unexpected impurities. In fact, chromatographic data is one of the crucial pieces of information assembled, with mass spectra and chemical information, in Luminata to help effectively manage impurity data in process development. As a chromatographer, since that’s still how I see myself at heart, I’m excited to see these traces take their rightful place.

Image002Luminata enables impurity management that incorporates live chromatographic data with all other relevant information for establishing effective control strategies in pharmaceutical process development.

Quality by Design (QbD) is the buzz world today for many environments, and also for the chromatographic separation. There are many parameters affecting a chromatography experiment. Their influence can be assessed following methods under Quality by Testing. This is a costly procedure because the issues are found after the experiment is done. QbD allows multi-variate parameter analysis with a minimum number of experiments. It also allows mapping of the entire design space, and within it, looking at the Normal Operating Ranges.

Image003Development of a chromatographic separation in ACD/AutoChrom follows QbD principles. It is based on scientifically logical and theoretically expansive criteria for investigation of maximum chromatographic space with a minimum number of experiments.

There are tomes of scientific publications about theoretical and instrumental chromatography, QbD, and impurity characterization platforms, and I’m not going to delve further into this world.

Chromatography, like many other things, can be loved or hated. If you happen to love it maybe, like me, you too can attribute it to an inspiring personality in your life. I was taught a long time ago: “Put a little passion in everything you do and you will succeed”.

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