It’s that time of year again. The presents were wrapped and then unwrapped, the Christmas tree is a shadow of its former self, we drank, we ate, we loved, we relaxed and we’re now wearing our stretchy pants until we get going with those self-promised New Year’s resolutions (or maybe that’s just me…). A new year is embraced by many as an opportunity for change, to make things better, to bring things up to date, to set and meet new targets. As we look beyond our personal lives and to that of our work in analytical science, the stars are aligning for a year of change and modernization.
2016 was all about the continued biologics boom, pharmacopeial modernization and regulatory alignment. As we move into 2017, the bio/pharma industry will be required to prepare for new standards, monographs, technologies and methods to bring life-changing drugs which are safer, more efficacious and targeted to market faster than ever before.
I wanted to share with you my ten resolutions to try and stay one step ahead of the fast-paced world of pharma and biopharma. Without further ado, let’s start the 2017 resolution charts!
10. Streamline your data systems.
Whether working to specific current good practice quality guidelines (cGxP), or simply wanting to keep your lab and processes ship shape, you should consider optimizing your existing instrument software, or renewing the software packages and workflows that you use. Working with compliance-ready data systems that can control numerous instruments from multiple vendors can minimize training burdens, automate workflows, simplify user experience and improve efficiency. Discover Thermo Scientific™ Chromeleon™ Chromatography Data System for compliance-ready data management, unified instrument control and simplified analysis and data reporting for chromatography and mass spectrometry (MS). Read how Regis Technologies, Inc. did it in this short case study. Also, Thermo Scientific™ Qtegra™ Intelligent Scientific Data System™ software platform is designed for a range of elemental and isotopic analysis technologies including inductively coupled plasma-optical emission spectrometry (ICP-OES), ICP-MS, noble gas MS, and isotope ratio infrared spectrometry.
9. Watch more videos.
Video is everywhere. But what’s watching your favourite shows on catch-up, or YouTube videos of cats got to do with pharma…well, nothing actually! But if you search the right keywords you will find many informative pharma and biopharma videos, vlogs and podcasts freely available — and as a bonus — videos take up less time and energy than reading written content! Here are a few I’d recommend:
- Two Scientists Walk Into a Bar Hosted by Jane Grogan, Principal Scientist of Cancer Immunology at Genentech — expect episodes every 2 weeks talking with top research scientists on everything from cancer vaccines to why we feel pain.
- BioPharMoore Hosted by…me! Expect new videos every 4-8 weeks covering all aspects of chromatography and MS for pharma and biopharma; interviews with industry experts, new products and techniques and event updates.
- ADC Review – ADC University, Changing Strategies in the “War on Cancer” video series. 30 minute documentaries — sit down to watch with a cup of tea. You’ll come away enlightened.
- Chrom Solutions YouTube Channel. Videos on all applications and aspects of chromatography, MS and associated techniques and software.
- Masses for the Masses YouTube Channel. Made by mass spectrometrists, for mass spectrometrists. Ever wondered who was using which kit and what they were using it for…well wonder no more!
- U.S. Phamacopeial Convention (USP) YouTube Channel. Get regulatory updates and expert insights.
- The Medicine Maker and The Analytical Scientist YouTube Channels. Expect a sneak preview of each edition and regular videos from industry experts.
8. Check out new guidelines.
The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) are the two major bodies to keep an eye on. I find the ECA Foundation/Academy a useful information source for Europe; you can sign up to weekly newsletters here. The FDA allows specific mail list subscriptions here. Whilst extra emails may sound like a pain (I do also put ‘unsubscribe from mail lists I haven’t found useful’ on my new year’s resolutions list!), I prefer to receive, skim read and delete if content is irrelevant rather than miss an all-important update.
7. Increase ROI.
Ultra high performance liquid chromatography (UHPLC) is revolutionizing drug development. Existing USP and European Pharmacopeia (Eu. Ph.) monographs and chapters are based on the use of more traditional HPLC methods (if based on the use of chromatography at all!), but with a set of allowable changes to these methods chromatographers are now able to push the boundaries and implement the newest column technologies within existing monographs. And in case you missed it, UHPLC offers reduced solvent consumption (lower cost…and greener!), faster sample turnaround (higher throughput!), and an overall increase in return on investment (ROI). Over time I expect UHPLC to become part of many new monographs, but for now you can see some examples of relevant UHPLC methods in the apps notes below, and if you haven’t already, I’d recommend getting to know the Thermo Scientific™ Vanquish™ UHPLC platform.
6. Dust off your DAD.
No, not your father! Your diode-array detector (DAD)! As part of the ongoing USP modernization initiative, it caught my eye that the use of DAD is being called out for compound identification/confirmation more explicitly; in recent USP submission guidelines it states under Section 4. Identification; 4.3. Liquid chromatography or gas chromatography:
“..Chromatographic retention times are characteristic of the compounds they represent but are not unique…using a diode-array detector…would allow both chromatographic and UV spectroscopic (if the UV profile is unique) identification of an analyte”.
Like what you are learning?
Advances in DAD technology with the Vanquish™ LightPipe™ Flow Cells for the Vanquish™ Diode Array Detector makes DAD once more a state-of-the-art piece of kit, for main compound detection through to trace-level impurities.
5. Raise your sugar levels.
I bet that’s never been on your list of New Year’s resolutions! Analysing carbohydrates, or glycans, is an integral part of many pharmaceutical (e.g. aminoglycoside antibiotics) and biopharmaceutical (e.g. glycoprotein therapeutics) product development, characterization and monitoring protocols. On 1st May 2016 USP <129> became official, detailing the use of ion chromatography (IC) for the analysis of sialic acids in biotherapeutics (check out my previous blog on this). The analysis of glycans necessitates a 360-degree view involving full characterization (macro- and micro-heterogeneity), localization and quantitation. Make sure you’re tooled up to get more sugar out of your samples, and keep on top of the latest kits and technology advancements.
4. Discover extractables and leachables.
Did I mention to watch more videos? Check out this installment of BioPharMoore interviewing industry experts from the National Institute of Bioprocessing Research and Training (NIBRT) to learn about the analysis of extractables and leachables in single-use bioprocessing technologies. And don’t forget, the recently finalized USP Chapter <661> may also mean you need to implement new tests on existing plastic packaging systems.
3. Invest in biologic reference standards.
Reference standards are physical reference materials that are used to ensure that products meet monograph and general chapter requirements, establish best practices and verify and improve analytical methods for quality control (QC). New standards are being developed that can be used to support the development and characterization of biologics. In the spirit of resolution 9 above, hear more about this from the USP in this video and this webinar!
2. Consider ion chromatography.
If you haven’t already heard, the USP has embarked on a global initiative to modernize many existing monographs across all compendia. If you don’t know IC already, you may want (or need) to! The most recent example is Proposed General Chapter <591>, which describes the determination of zinc content in zinc containing drug products using IC (you can create a login for the USP– National Formulary (NF) here and see stimuli articles for which USP is seeking public comment). This particular proposed revision is in response to requests from the FDA to improve methods and thereby quality of over-the-counter (OTC) products. Learn more about the value of IC in this recent blog about monograph modernization and hear Dr. Ravi Ravichandran from the USP explain the role of IC in the modernization initiative in this informative webinar.
1. Take control of elemental impurities.
Finally, in pole position – make sure you’re ready for the new limits and procedures for the analysis of elemental impurities, official on 1st January 2018. That may seem like a long time away, but a year to acquire, validate and implement new technology is not very long and the FDA is actively supporting and encouraging early adoption. The USP (USP <232> – Limits and USP <233> – Procedures) has worked closely with the International Conference on Harmonization (ICH) to ensure alignment with the ICH Q3D Guideline for Elemental Impurities. These new standards stipulate the use of ICP-OES and/or ICP-MS – and if you’re not sure what your lab needs check out this great blog from Dr. Maura Rury where all is explained. You can find more information in this useful primer and in our Elemental Impurities Learning Center.
So, there you have it. 2017 sorted. Should you need a couple more ideas, I also plan to get outdoors more and get more sleep – you can have these resolutions for free too, they’re scientifically validated, of course.
Happy New Year!