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It is a real honour to be appointed Chair of the CAMS Industry Advisory Board, following on from Mark Seymour. I’d like to thank Mark for all his work for CAMS and wish him a very happy retirement.

Analytical scientists in the pharmaceutical industry are being constantly challenged to work with an ever-increasing diversity of chemical and biological entities. The ongoing efforts to beat COVID-19 exemplify this, as collaborations across academia, industry and technology providers race to develop vaccines, innovative treatments and testing methodologies. And, in all these areas, analytical and measurement science will make a massive contribution.

Another hot topic that reinforces the essential role of analytical science in the pharmaceutical industry is nitrosamine trace analysis. Over the last two years the nitrosamine challenge has exponentially expanded and is one of the major issues facing the global industry. It has resulted in product recalls, has the potential to restrict the availability of some medicines and has become high profile within the media.

From the initial focus on trace nitrosamine levels in Sartans drug substance, the scope has greatly expanded. It now encompasses all synthetic and biologic drug substance, the evaluation of levels in drug product and nitrate and nitrite levels in associated excipients. More recently, the risk of nitrosamine formation in packaging processes has also come under scrutiny. As the scope has expanded, the trace analysis challenge has grown. LOQs and LODs were typically set at 15 ppb and 5 ppb respectively. However, recent regulatory challenge may drive these down further to LOQs in the region of 5 ppb and LODs at sub 1 ppb level.

Issues of method robustness, sample preparation, unexpected sources of nitrosamine contamination and associated risk of false positives have contributed to the challenge. The implications of false positives are enormous, having the potential to severely impact supply of essential medicines. Therefore, we need a high confidence in the data generated for nitrosamine to maintain public trust, as illustrated by a recent high-profile example.

The global analytical science community within the pharmaceutical industry has responded with significant investment in state-of-the-art analytical technology and collaborations with instrument and column manufacturers to advance the capability of that technology. In parallel, the demand for testing at analytical science contract research organisations (CROs) has greatly increased. It has also been essential to influence the external regulatory landscape and develop cross pharmaceutical industry collaborations.

All elements of analytical science are required to achieve the challenging LODs and LOQs. High resolution LC-MS/MS and GC-MS/MS, along with IC-MS, is being applied for quantitation and structural confirmation. Bespoke sample preparation methods are required due to the variety of drug substance and drug product sample matrices. New separation science methods and column technology are being evaluated.

Nitrosamine trace analysis again illustrates how essential it is that we develop the current and next generation of analytical scientists and innovate in many areas of technology. The importance of the skills of analytical scientists from a societal perspective is clear. Now every day is nitrosamine day and it is inspiring that analytical science is leading the charge to tackle the issue and will demonstrate the safety of medicines, for many diseases, required by the millions of patients around the world.

Tony Bristow - CAMS Industry Advisory Board Chair                                                                                                                                                                                                             Chemical Development, Pharmaceutical Technology and Development, AstraZeneca, Macclesfield, UK

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The COVID-19 pandemic has affected all of us over the past few weeks and has forced us to change the way we live and work.  But in adversity lies opportunity.  Many measurement scientists will have been directly applying their skills as part of the efforts to defeat the disease and CAMS provides an excellent forum for us to share our expertise and form new collaborative alliances.  Most of us have also found ourselves spending a lot more time working from home and this seems to have generated a huge increase in demand for online learning resources such as webinars, training videos and interactive educational resources.  Again, CAMS has been able to play its part by offering online materials through BEAM.  That said, BEAM is still at an early stage of development and further contributions of high-quality training materials would be very welcome, please don’t hesitate to contact the CAMS Secretariat if you have something in mind.

Of course, the pandemic will not last forever and normality will return at some point.  We will be staging our first CAMS conference in September and we are still hopeful that it will be a face-to-face event rather than virtual.  CAMS members are involved in world-class research both in academia and in industry and I would urge all member organizations to consider presenting some of their work at the event.

Talking of research, now that CAMS exists as a legal entity (CAMS Ltd.) and we have someone to pay our subs to, there should be no obstacle to initiating collaborative research projects between industrial and academic partners.  Several ideas have already been mooted and now is the time to dust them off and make at least some of them happen!

Lastly, I will be retiring in September and so will stand down from the Industry Advisory Board at that time.  I have enjoyed my brief spell in the chair and I am pleased (as well as relieved) that we finally managed to get the CAMS membership agreement over the finishing line.  I wish CAMS and its members every success in the future.  I chose analytical science as my own career and found it immensely rewarding.  I’d like to think that CAMS will play a prominent part in fostering many more analytical science careers in the future.

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