The Analytical Scientist

60 Pages·2022·20.369 MB·English

MARCH / APRIL 2022 # 104
Upfront In My View Feature Sitting Down With
Inaccurate labeling of Academic integrity Unraveling the world’s FPOP Star,
cannabis vapes revisited most complex mixture Lisa Jones
06 09 – 10 26 – 31 58 – 59
Not So Fast...
Ultra-low detection limits.
Increasingly severe penalties.
Is the system becoming
unfair to athletes? We explore
the incendiary issue of
sports doping.
14 – 25
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Straight to the Core
Editorial
Honing in on the topics at the core of The Analytical Scientist
– and revealing some exciting plans ahead…
T
he eagle-eyed among you may have noticed a
slight change to the format of our last issue.
Missed it? Well, turn to page 33 – or take a
look at the previous digital issue online. That’s
right – it’s my pleasure to retrospectively introduce “Core
Topics.” From short interviews with key names in the field
to practical tips and tricks, each new section – whether mass
spec, chromatography, spectroscopy, or (bio)pharma – acts as
a hub for content developed for that specific area of analytical
science. Moreover, the Core Topics in print reflect a greater
emphasis on those areas in the digital sphere…
And that leads me directly to another exciting launch: the
Mass Spec newsletter. We all know MS is constantly hitting
new strides and the research occurring in this space is frankly
exhilarating. Just take a look at our cover feature on sports
doping from Douwe de Boer (page 15) – it’s clear that MS will
play a commanding role in the “war to close Pandora’s Box.”
And, if you head over to the Mass Spec Core Topic (page
33), you’ll get a glimpse as to how MS is constantly pushing
boundaries – the technology constantly moves in exciting new
directions (check out the story behind high-resolution ion
mobility MS, as one good example).
With more happening in the space than ever before, we
decided it was high time to launch a dedicated newsletter to
help better serve the community – a space for #TeamMassSpec
to flourish! Mass Spec from The Analytical Scientist will not
only keep you up-to-date with the latest advancements in
technology and the most exciting research and applications,
Coupling powers
but also bring together (and amplify) all the different voices
in the field.
Since I joined The Analytical Scientist team, mass spec has
consistently captured my attention. Was it the many exciting
Pioneering new fields in ultra-trace analysis, the Comfortable, easy change of accessories applications passing by my window into the field? Was it the
new GCMS-TQ 8050 NX triple quadrupole couples through the advanced, illuminated GC oven indecipherable new acronyms or the increasingly long chains of
the powers of a world-leading GC and a newly advanced technologies? Maybe it was the addictive enthusiasm
designed detector. Both provide outstanding sensi- The GCMS-TQ 8050 NX complements the I’ve encountered when speaking to some of you. It’s likely all
tivity at femtogram and even sub-femtogram levels. Shimadzu NX family, coupling the Nexis GC-2030 of those things. But what I know for sure is that I’m thrilled to
with the quadrupole series TQ-8050, TQ-8040 or have the chance to create and grow a special place for a clearly
Superior performance of NX technologies QP-2020. Shimadzu’s NX series provides high-end passionate community.
e.g. new flow controller and time management GCMS solutions for every analytical challenge.
for maintenance
Lauren Robertson
A wide variety of optional products supports Deputy Editor
trace analysis
such as autosamplers and inlets
www.theanalyticalscientist.com
www.shimadzu.eu/coupling-powers
Contents
58
In My View
08 Without the right predictive
tools, the exciting field of cell
and gene therapy won’t reach its
full potential, argues
George Buchman
09 Victoria Samanidou believes we
all have a role to play in
maintaining standards in
citation ethics
10 Mike Easterling: It's time
26 to realize the advantages of
mass spectrometry imaging in
clinical research
03 Editorial Upfront
Straight to the Core, Features
By Lauren Robertson 06 Reporting on recent
breakthroughs, from NMR 14 N ot So Fast…
spectroscopy-based urine Is the anti-doping system
profiling and metabolic health becoming unfair to athletes?
On The Cover to detecting inaccurate labeling What role should scientists play in
of cannabis vaporizers ensuring the system is balanced?
You might think you know who What will the next generation of
won, but the race isn’t over anti-doping technology look like?
until the analytical scientists Several questions jostle for the
have had their say… podium in our feature on sports
doping.
ISSUE 104 - MAR/APR 2022
Feel free to contact any one of us:
[email protected]
Content Team
Editor - James Strachan
Lauren Robertson (Deputy Editor)
Margot Lespade (Associate Editor)
Frank van Geel (Scientific Director)
Commercial Team
Publisher - Lee Noyes
Gaurav Avasthi (Associate Pubisher)
Chris Clark (Business Development Manager)
Design Team
Creative Director - Marc Bird
Hannah Ennis (Senior Designer -
Commercial)

Digital Team
Digital Team Lead - David Roberts
Peter Bartley (Senior Digital Producer)
Shea Hennessey (Digital Producer)
Oliver Norbury (Digital Producer)
Audience Team
Audience Growth Strategy Manager
– Brice Agamemnon
45 Jody Fryett (Salesforce & Audience
Sytems Manager)
Jamie Hall (Audience Insights Analyst)
CRM & Compliance
CRM & Compliance Manager - Tracey Nicholls
Commercial Services
26 Complexity Resolved? 43 Spectroscopy: The latest Commercial Service and Social
Media Manager - Matt Everett
Mark Barrow explains how the spectroscopy breakthroughs, Lindsey Vickers (Sales Support Manager)
development of new methods a wearable brain scanner and Hayley Atiz (Sales Support Coordinator)
Julie Wheeler (Sales Support Coordinator)
to unravel the most complex taking LIBS to the next level Anna Harbottle (Video Producer)
Sophie Hall (Social Media Executive)
mixture of all – petroleum Aliki Zapties (Project Coordinator)
Lilly Pratico (Project Coordinator)
– bears fruit in many other 47 (Bio)Pharma: Can analytical
Marketing Team
applications areas, not least science take cell therapy Marketing Manager - Katy Pearson
environmental analysis manufacturing to the next level Jo Baylay (Marketing Executive)
Magda Brzegowy (Marketing &
with in-line measurement of Events Executive)
critical quality attributes? Accounts Team
Kerri Benson (Accounts Assistant)
Emily Scragg (Accounts Payable/
Accounts Receivable)
Core Topics
Human Resources
Human Resource Manager - Tara Higby
33 Mass Spec: How MOBILion Sitting Down With Management Team
Chief Executive Officer - Andy Davies
went from a sketch on a piece Chief Operating Officer - Tracey Peers
of paper to launch in five years, 58 Lisa Jones, Associate Professor Senior Vice President (North America)
- Fedra Pavlou
with CEO and founder of Pharmaceutical Sciences, Financial Director - Phil Dale
Commercial Director - Richard Hodson
Melissa Sherman University of Maryland, Content Director - Rich Whitworth
Creative Director - Marc Bird
Baltimore, USA
41 C hromatography: Is
Change of address [email protected]
chromatography still losing the Tracey Nicholls, The Analytical Scientist, Texere Publishing
Limited, Booths Park 1, Chelford Road, Knutsford, Cheshire,
war? According to Hans-Gerd WA16 8GS, UK
General enquiries
Janssen, “chromatography will www.texerepublishing.com | [email protected]
[phone] | [email protected]
never disappear.”
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Advisory Gary Hieftje, Indiana Institute, USA University of Amsterdam, copy, modify, transmit, distribute, display, reproduce, publish, licence or create works from
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Emily Hilder, University of College London, UK Monika Dittmann, Netherlands
South Australia, Australia Jenny Van Eyk, Director Independent Analytical Samuel Kounaves, Tufts
Frantisec Svec, University of of the Advanced Clinical Scientist, Germany University, USA
6 Upfront
Upfront
Research
Fake It Till Innovation
Trends
You Vape It?
Inaccurate labeling is
rife among delta-8 THC
vaporizers, with many
containing unacknowledged
adulterants and unintended
byproducts
Despite the lack of information around
their safety, e-cigarettes and vaporizers
containing hemp-derived delta-8 THC the HPLC-UV methods used by the take these findings as a stark warning.
continue to rise in popularity. Few would various labs for testing,” says Rahman. “Our study also highlights the
disagree that more data on their health On top of this, all of them contained problems with the existing cannabis lab-
and safety implications are needed – reaction side-products (including Δ9- testing infrastructure; if regulators don’t
especially in light of the vaping use- THC), heavy metals, and a previously enforce strict certification of testing labs,
associated lung injury (EVALI) outbreak. undescribed cannabinoid – and 11 had policies around product potency and
To dig into the issue a little deeper, unlabeled cutting agents. composition won’t be enforced,” says
Irfan Rahman and Jiries Meehan-Atrash “What was particularly striking Rahman. As for the future, the duo
from the Department of Environmental was the diverse mix of cannabinoids wants to keep analyzing the chemistry,
Medicine at the University of Rochester, in the products. Someone consuming toxicity, and human health effects of
New York, analyzed 27 products from 10 traditional cannabis would not be THC isoform products.
brands using a combination of 1H-NMR exposed to these, and we simply have
spectroscopy, GC-MS, and ICP-MS no idea what impact they might have Reference
(1). What did they find? “The reported on the brain or respiratory system,” adds 1. J Meehan-Atrash and I Rahman, Chem Res
lab test values were all inaccurate – Meehan-Atrash. They suggest people Toxicol, 35, 73 (2022). DOI: 10.1021/acs.
likely due to a lack of optimization in that use delta-8 THC vaporizers should chemrestox.1c00388
Cracking Research have discovered by chance Armed with this new knowledge, the
that Portland cement emits near- team applied a layer of opaque paint
Down on infrared fluorescence, which could lead to a cement block and compressed it
to new ways of monitoring the integrity to induce microcracks, exposing the
Concrete of concrete structures (1). substrate’s near-infrared emissions
Originally, the researchers intended and revealing the fracture locations,
Damage to test whether nanotube-based strain pattern, and progression.
sensing technology could be applied “This could evolve into a practical
to monitor concrete structures – but method for inspecting critical concrete
Photoluminescence
they found an unexpected interfering structures for early signs of damage,
spectroscopy sheds light
emission that they traced back to thus helping to prevent costly and
on early signs of concrete
the cement itself. “We deduced dangerous failures,” says Weisman.
damage
that it contains microscopic crystals
of silicon emitting near-infrared Reference
Researchers from Rice University and photoluminescence,” says Bruce 1. Weng et al., Sci Rep (2022). DOI: 10.1038/
the Kuwait Institute for Scientific Weisman. s41598-022-05113-1.
Nature Calls for
I M AG E OF THE MONTH
a Mediterranean
Diet
Nuclear magnetic resonance
(NMR) spectroscopy-based
urine profiling has linked the
Mediterranean diet with good
metabolic health
Metabolic “signatures” in urine can
be used to determine diet quality and
predict metabolic health, according
to researchers from the University of
Southern California, USA (1).
The team examined urinary
metabolites from 1147 European
children and collected information
The Art of Proteins about their dietary habits. Using
NMR spectroscopy, they discovered
Last year, Irina Bezsonova – a structural biologist from the University of that children who followed a
Connecticut – created a collection of ink drawings in celebration of 50 years of Mediterranean diet had higher levels
the Protein Data Bank archive. With some help from the Twitter community, of hippurate, N-methylnicotinic acid
Bezsonova selected one protein every day that aligned with the official “Inktober” and urea, and lower levels of sucrose.
prompt – words like “crystal,” “knot,” and “sour.” Above, you can see the drawing But for those who consumed ultra-
created for the “loop” prompt – an NMR spectroscopy structure of the outer processed foods, the opposite was true.
membrane enzyme PagP being represented with some knitting needles. Crucially, the researchers found an
association between C-peptide – an
Would you like your photo featured in Image of the Month? accurate marker of insulin resistance
Send it to [email protected] and future risk of metabolic disease –
and those metabolite profiles; higher
adherence to a Mediterranean diet
was associated with lower C-peptide
Q U O T E levels, while an ultra-processed diet
OF THE MONTH
was linked to higher C-peptide levels.
“Our work provides further
evidence to support efforts by
public health authorities to
“The human immune system can make quintillions of slightly different antibodies
recommend increased adherence to
– a nearly infinite resource. When one of these antibodies is successful, the body
a Mediterranean diet,” said Leda
makes more copies. As a result of lifelong training, we only make antibodies that
Chatzi, one of the authors of the
are really needed – only about a couple 100 or so will ever be dominantly present
study, in a press release (2).
in our blood. What if we could discover which antibody fights which threat the
best, and turn them into biotherapeutics?”
References
Albert Heck during his Pittcon Wallace H. Coulter Lecture on the 1. N Stratakis et al., eLife (2022). DOI:
groundbreaking findings his team uncovered using native-MS – and their 10.7554/eLife.71332
potential to transform how we treat disease <https://bit.ly/3qn324z> 2. ScienceDaily (2022). Available at:
https://bit.ly/3IB8wPY
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
8 In My View

In My
View
Experts from across the
Rising to the
world share a single
strongly held opinion
Analytical
or key idea.
Challenge
of Advanced
Medicine
Cell and gene therapies
are incredibly exciting, but
without the right predictive
analytical methods and tools
to ensure safety and efficacy,
the field will be held back
By George Buchman, Vice President,
Pre-clinical and process development,
Catalent Cell & Gene Therapy
Cell and gene therapies have emerged in
recent years to stake their claim as one
of pharma’s “big three” – alongside small availability of multiple novel viral most wild-type, common serotypes. But
molecule drugs and biopharmaceuticals. vector serotypes with specific biologic these immune-based tests are typically
And, as the cell and gene therapy properties, including improved tissue not available for novel and proprietary
industry matures, analytical science targeting and reduced immune response. serotypes, so A280 (of purified viral
is playing an increasingly important It is necessary that novel serotypes vector) or other means are used to
role – especially when it comes to undergo exhaustive physical and quantify capsid.
understanding the safety and potency of biological study. To address these and More challenging assays measure
therapeutic vector elements ahead of first other testing needs, techniques currently residual DNA, infectivity, potency,
in human (FIH) studies – and certainly used by analytical scientists in other transduction efficiency, and correlation
before commercial launch. fields are expanding into use for cell to clinical outcome. For example, residual
Given that cell and gene therapies and gene therapies. For novel serotypes, DNA that is typically measured by
are relatively immature compared methods may include sequence quantitative PCR (qPCR) may actually be
with monoclonal antibodies and other homology analysis, atomic modeling, packaged within the capsid. In addition
biologics, we are constantly improving cryogenic electron microscopy (cryo- to qPCR for residual packaged host cell
our viral vector production methods EM), MS, next-generation sequencing DNA, analytical ultracentrifugation
– and we rely on evolving analytics (NGS), cell binding studies, packaging (AUC) provides an effective means to
to accurately characterize efficacy, efficiency, transduction efficiency, monitor for vector packaging fidelity,
purity, and potency. The establishment potency and infectivity measures, and including intermediate forms that may
of analytical methods that can of course animal efficacy and toxicology, not be functional. Small-scale batch
demonstrate true comparability is of as well as human clinical safety trials. processing early in product development
critical importance – just as important Many assays are well established and in conjunction with key analytics
as advancements and improvements routine, including compendial testing provides valuable insight into vector
in manufacturing methods, which is a and viral genome titer by digital droplet quality attributes to avoid issues in later
major talking point within the field. PCR (ddPCR). ELISA-based capsid development. We are at an early stage in
An area that is also evolving is the titer assays are readily available for the evolution of cell and gene therapies,

In My View 9
and clinical outcomes will let us know tested exhaustively, and particularly around as cryo-EM, MS, and in-silico modeling.
if our current analytics are suitably adventitious viral agents. Similarly, plasmid In some ways, we are already living
predictive of safety and efficacy. quality is paramount to establish an efficient in the future. Diseases such as spinal
Other challenges include the detection transfection process (the most typical way muscular atrophy (SMA) that were
of some virus-based contaminants, for to prepare viral vectors) to form gene previously not treatable, and terminal
example replication-competent adeno- and gene-enabled cell therapies. Release by age two, now have a commercial cure
associated viral (rcAAV) vectors. testing for viral vectors is exhaustive, available. The field will begin to mature as
Recombinant AAV vectors (rAAV) are including standard compendial methods it did for monoclonal antibody therapies,
inherently not replication-competent (for example, osmolality and pH), safety with improvements in production yields
nor are they pathogenic, but there is a testing (adventitious agent and rcAAV that will correlate with reduced levels
risk of the formation of a wild-type form detection), residuals testing, titer-based of impurities per unit dose, access to
of the vector by recombination during (ddPCR and ELISA), purity and structure treatments and cures to more patients,
production. These forms are more likely (SDS-PAGE and capillary electrophoresis), and decreased costs. And that will lead
to insert in the patient genome and can and aggregation (dynamic light scattering to new treatments and cures entering the
increase immune and oncogenic potential. and HPLC), among others. clinic for hundreds of diseases. Out of
Another testing challenge is looking Viral vector characterization specifically necessity, the analytics will have to keep
for contaminating AAV serotypes and is a significant challenge for the field. up – especially with the need to correlate
other viral vector species (adenovirus, The sheer number of vectors (multiple clinical outcomes with our ability to
retrovirus, etc.) in a batch, particularly serotypes), vector platforms (AAV, measure critical quality attributes.
for facilities that produce multiple types. lentivirus, adenovirus, retrovirus), It’s an incredibly exciting field, but
Few laboratories at present perform this potential candidates for gene of interest, we need vigilance around the analytical
testing, though it is gaining regulatory multiple packaging platforms, numerous methods that are predictive and help
and safety importance. production methods, and the constant to assure safety and efficacy. Novel
For both gene and cell therapies, evolution of the field keep viral vector serotypes will offer better targeting and
the quality of process inputs is critical. characterization very challenging. As reduced off target effects, perhaps with
For established serotypes and vectors, stated for novel vector development and reduced dosing. If we all move forward
including AAV wild types 1–10, master characterization, these analyses may together, the future really does hold
cell banks for viral vector production are involve many non-standard methods, such amazing promise.
Cite Your Sources: the submission. (The latter is comic because
it eventually reveals the identity of the
Academic reviewer!) And although some suggestions
were reasonable due to author oversight and
Integrity papers being reported inappropriately, more
often than not, they were unethical.
Revisited References form an indispensable part of a I am also well aware of the fact that
manuscript. They ensure integrity, allow the editors and reviewers should make all
reader to locate existing work, and offer a possible efforts to improve the quality of a
Maintaining standards
snapshot of the relevant research. manuscript that will appear in a published
in citation ethics is a
But, over the years, I have encountered journal. What’s more, I know that reviewers
responsibility that lies with
several questionable responses after work on a voluntary basis. But scholars acting
each of us
manuscript submission. For example, as reviewers should not expect anything
editors asking for more citations with back – not even in the form of increasing
By Victoria Samanidou, The Laboratory references from their journal, potentially their h-index. And yet what happens when
of Analytical Chemistry, Department altering journal metrics; or reviewers a reviewer realizes that their own work was
of Chemistry, Aristotle University of putting put forward additional – largely not given sufficient credit? Should they ask
Thessaloniki, Thessaloniki, Greece irrelevant – citations of their own work to for it? Where do we draw the line between
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
10 In My View
self-promotion and genuine recognition? and their work on the topic. Moreover, consequences should be applied (2-4).
This also raises the question: is it easy self-citations do not increase an author’s Journal guidelines should indicate
for an author to distinguish between h-index (though they may skew journals’ their policy and potentially ask authors
a legitimate reviewer suggestion and a ratio-based metrics). Personally, I do not see to limit self-citations. But academic
manipulation based on self-promotion? In an issue with this, as long as the citations integrity and citation ethics should rely on
my opinion, the answer is yes. In the first are strictly necessary ones. Authors should authors’ values, not on rules and penalties.
case, the additional suggested papers are not use their research papers to flaunt career Maintaining ethical standards in academia
always limited to scientifically necessary achievements, but to provide information is a responsibility that lies with each of us
material and very close to the topic. In the that supports the data, the necessity of the as individuals and scientists.
second, irrelevant papers are proposed, research, or its importance to the field.
sometimes hidden among relevant ones. According to the Committee on References
The author must then decide whether to Publication Ethics, all references should 1. COPE Council, “Reviewers requesting addition of
risk rejection or add all suggested references contribute to the scholarly content of the multiple citations of their own work” (2019).
to ensure the paper is accepted. I hope that article (1). There are instances where self- Available at: https://bit.ly/3onUvNM.
most scientists would choose the latter, but citation and requests for additional citations 2. COPE Council, “Citation manipulation” (2019).
there are real incentives to “play the game.” are legitimate, but all other requests that may Available at: https://bit.ly/3GsZgvw.
Another ethical question is self-citation. violate publication ethics should be avoided. 3. COPE Council, “COPE Forum: 13 November
How many self-citations are reasonable? Furthermore, reviewers should refrain from 2017: Self-Citation: Where’s the line?” (2021).
In my view, all recently published papers suggesting citations to promote their own Available at: https://bit.ly/34AWiIk.
on the specific topic should be mentioned, work and all suggestions must be based on 4. COPE Council, “Citations: Link, Locate,
regardless of self-citation. Self-citations scientific reasoning. Misconduct should Discover, Connect” (2018). Available at: https://
can help paint a clear picture of the author be reported and penalties or respective bit.ly/3GngWJ6.
Be Certain with Restek
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Clinical Research Looking back on these developments, one Reference Standards
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clinical research
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• Professionally formulated mixes reduce time, expense, and
By Mike Easterling, Imaging Business and management of cancer. Over the past of cellular components that dictate disease
uncertainty compared to in-house preparation.
Manager, Bruker Daltonics, Billerica, couple of decades, as we have uncovered outcomes include immunohistochemistry,
• Single and multicomponent standards covering a wide range of
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All pharmaceutical scientists share diagnostic histopathology with the use of these techniques offers useful targeted
a common goal – to accelerate drug molecular labels and probes. If we combine information about proteins in tissues, they
discovery and development efforts through this with the knowledge provided by the also have challenges – for instance, their
a deeper understanding of biomarkers and Human Genome Project in the 1990s and inability to capture the variety of post-
Quality Counts
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laser desorption/ionization (MALDI) (TCGA) program that began in 2006, and In contrast, MALDI imaging presents Restek certified reference materials (CRMs) are
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