Back in the 80s and early 90s we used pens and paper at school. We referred to text books and went to the library or spoke to our elders to find out answers for our homework. Only last week I was invited to my 7-year-old’s school to discuss ‘phonics’ and ways of helping our children to pass their upcoming government-mandated tests. The teacher showed us the ‘apps’ we should download for them on our tablets (presumptuous, I thought. What if we don’t have one? Of course, we do.), the videos on YouTube we should encourage them to watch and all of this was conveyed on a PowerPoint deck which they projected onto a whiteboard. We can look at these changes over the past 20 years and grumble about what we do and don’t approve of, what we think works best, what it was like ‘in our time’. But, there is one thing that I know for sure, the information that is available to our children is now vaster, more accessible, and more detailed than ever before. To me that’s definitely a positive change.
It’s hardly surprising that we see similar trends elsewhere. One area that I have noticed this is analytical science, and in particular pharmaceutical and biopharmaceutical analytical science.
Continuous innovation is the pharmaceutical industry’s most defining characteristic. In the early 1900s there was little to no link between the pharmaceutical industry and the life sciences and the majority of medicines were derived from natural plant products with scant formal safety or efficacy testing. WWII saw a surge in demand for antibiotics which drove pharmaceutical companies to invest heavily in R & D for the first time.
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After the war the demand for cures to never before seen illnesses continued and this forced scientists to begin random compound screening and to establish the rudiments of a drug discovery and development process. In the 70s significant advances in the life sciences -- physiology, enzymology, molecular biology -- propelled the understanding of the biochemical and molecular mechanisms of many diseases and the action pathways of existing drugs. The second significant leap came for pharma in the late 70s/early 80s when biotechnological methods of drug production were developed, finally bringing pharma and the life sciences together to design and engineer new, more targeted therapies. In line with the evolution of drug discovery and development a regime for testing the safety, efficacy and quality of drug products was also established and regulatory bodies amassed.
Pharma: Job done! Analytical Science: No way!
Somewhat surprisingly, many of the methods, monographs and assays which exist in the pharmacopeias and regulatory guidelines of today, are based on classical wet chemistry procedures which are often time consuming, labour-intensive, involve hazardous chemicals, require extensive analyst training, and may yield significant measurement errors.
Thankfully, evolution has far from halted for these guidelines and the bodies who control them, undoubtedly with safety top-of-mind, the largest pharmacopeia in the world, the United States Pharmacopeia (USP) is in the midst of modernization.
The Future-Ion Chromatography to the Rescue!
Ion chromatography (IC) offers a significant improvement to many assays, and modern IC systems have much more to offer than meets the eye…
What are the goals and timelines of USP monograph modernization initiative?
What is the role of IC in monograph modernization?
Who is actually using IC in pharma, and what are they using it for?
Make sure you catch up on this webinar, where Dr. Ravi Ravichandran (Principal Scientific Liaison, Chemical Medicines, US Pharmacopeial Convention) reveals all on the role of IC in USP monograph modernization, including the presentation of selected case studies where IC has been successfully adopted for monograph modernization.
If you’re involved in product development, raw ingredient testing, process monitoring, QA and/or labelling control, involved in regulatory standard-setting agencies or you’re simply interested in using IC for inorganic analysis in pharmaceuticals, it’s a must-see (and is much more interesting than phonics videos on YouTube!).
After watching the webinar if you still have questions on IC and the modernization initiative please post them in the comments box below; let’s modernize pharmacopeia together.