#StandardsGoals for 2024: What’s new for BISAC - Tech Forum 2024
2011 waterscalendar us_final
1. [ 2011 Calendar ]
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2. Fake perfumes are not only a financial problem for the fragrance industry but a health problem for
consumers. As you might expect, bootleg perfumes are never tested for safety issues. Skin burning,
rashes, and respiratory problems are the most common complaints.
Adulterations and forgeries of high end perfumes are a big business everywhere, but especially
in Brazil where the street markets are packed with unsuspecting shoppers looking for a bargain.
But Brazil also has a potent weapon in the fight against faux fragrances. It’s the Thomson Mass
Spectrometry Laboratory located at the University of Campinas.
A normal analysis would take hours, but utilizing their own special method of identification and
Waters mass spectrometry equipment, the scientists get back extremely accurate results in minutes.
The perfume is sprayed onto a piece of paper, and then it goes to a Waters high resolution mass
spectrometer. In no time, a chemical profile is produced and clearly identifies the product as
authentic or fake.
And that’s as real as it gets.
University of Campinas, BrazilHEAR THE FULL STORIES AT W W W.WATERS.COM/CUSTOMERS
The only thing real about the perfume was the rash it left behind.
4. Regis Technologies is a contract manufacturer whose unique specialty is SFC separations performed
under GMP using Supercritical Fluid Chromatography (SFC) from Waters.
SFC is similar to liquid chromatography but with one big difference. It utilizes carbon dioxide instead
of solvents. Not only is it environmentally friendly, it offers both cost- and time-efficiencies without
sacrificing purity.
In fact, Regis technicians routinely use this green method of chromatography to handle the most
delicate procedures, such as impurity collections down to one-tenth-of-one-percent impurity for
toxicology studies. The ability to pull such miniscule fractions is critical to success.
Not long ago, a biotech client working on a cancer drug urgently needed more pure material in order
to continue clinical trials at a larger dosage. With the SFC equipment already fully optimized, Regis
gave the green light to manufacturing 24/7 for 34 days straight.
They not only completed the project successfully, they finished one week early.
Regis TechnologiesHEAR THE FULL STORIES AT W W W.WATERS.COM/CUSTOMERS
How to go green, make a lot of green, and leave the competition green with envy.
6. And they love what they’re seeing.
At GlaxoSmithKline (GSK), a leading worldwide pharmaceutical company, a team of scientists uses
dry blood spots instead of plasma for pharmacological testing.
In this method, a small amount of blood is sprayed onto a card, then dried, and sent for bio-analysis.
Less need for blood means less demand on animals and humans which equals major ethical and
economic advantages. The cards are also much easier to ship and store than plasma.
But the minimum volume of blood also presented challenges to GSK in achieving the proper level
of sensitivity required for some methods and compounds.
What to do?
The answer arrived in two instrument platforms from Waters: the TRIZAIC UPLC®
System with
nanoTile™ Technology and the Xevo®
TQ-S mass spectrometer. Independently, each achieved multiple
increases in sensitivity over traditional platforms. But when GSK scientists coupled the two Waters
instruments, they saw increases in sensitivity jump hundreds of fold over what they had been using.
There’s nothing spotty about that kind of performance.
GlaxoSmithKline (GSK)HEAR THE FULL STORIES AT W W W.WATERS.COM/CUSTOMERS
Entire scientific team begins seeing spots.
8. It was truly a mystery. The what, the how, the why, all covered in question marks. Let’s start with
the who.
The scientists at the Service for Consumers and Veterinary Affairs (SCAV) in Geneva, Switzerland
are responsible for a wide range of testing, including food quality, restaurant norms, veterinary
medicines, and pesticides.
One day, a SCAV team conducted a study on pesticide residue in Lake Geneva. Unlike most labs who
look only for classic Triazines and their metabolites, the SCAV scientists, armed with their Waters
mass spectrometry instrumentation, applied a wideband method to the samples and discovered,
lo and behold, Sulfuron in high concentrations.
But instead of hearing shouts of ‘bravo’, the test results were met with cries of ‘C’est impossible!”
How could there be concentrations equivalent to 150 years of agricultural usage for Sulfuron when it
was only a few years old?
Go check again. Again the tests confirmed the analysis. It was then discovered that a factory upstream
from the lake was releasing the compound. Mystery solved.
Service for Consumers and Veterinary Affairs (SCAV)HEAR THE FULL STORIES AT W W W.WATERS.COM/CUSTOMERS
Between the factory and the lake was a river of woe.
10. Walk into the Astbury Centre for Structural and Molecular Biology at the University of Leeds (UK) and
you will find an elite group of experts on the subject of proteins and how they unfold. Protein behav-
ior has been directly linked to disease. Find a way to keep proteins from ‘misbehaving’ and some of
our toughest diseases might be cured.
The university uses Waters SYNAPT®
Mass Spectrometer. And for very good reason. It is the
only commercial instrument to offer the ion mobility separation so important to the team’s
work on virus capsids. A capsid is the protein shell that surrounds a virus particle. A virus
must invade living cells to remain alive and do its dirty work. So the team from Leeds
is working on using the capsid as a drug transporter or a “molecular submarine”. The goal
is to speckle the capsid with drug molecules and then the virus capsid would take the drug
molecules to a specific cell in the body.
It’s down-the-road thinking, but it’s an idea that could usher in a new world of drug therapies.
University of LeedsHEAR THE FULL STORIES AT W W W.WATERS.COM/CUSTOMERS
Can a perilous virus become a potent healer?
12. It can when it doesn’t pass FDA regulations.
As recently as 10 years ago, industry experts estimated that half of all dietary supplements in the
marketplace could be adulterations.
That was then. This is now. Because three years ago, the FDA issued a GMP regulation requiring all
dietary supplement manufacturers and raw materials suppliers to adhere to tough new requirements.
Those companies turned to major testing labs like Analytical Laboratories to receive the most
accurate data possible.
For Analytical Laboratories the issue was not only accuracy but speed. One multi-vitamin pill can
contain up to 30 different ingredients. Separation via traditional HPLC can take 30 minutes or more.
The ACQUITY UPLC®
/Xevo®
MS systems can analyze complex samples or scan up to 300 pesticides
in a single run taking just 5 or 10 minutes. That’s why Analytical Laboratories relies on Waters.
UPLC®
also delivers better resolution and cuts reagent use by 80%. Analytical Laboratories has
purchased at least one Waters®
UPLC system every year since it was introduced.
They know UPLC is the future. And the future is now.
Analytical LaboratoriesHEAR THE FULL STORIES AT W W W.WATERS.COM/CUSTOMERS
Can a dietary supplement actually be a dietary detriment?
14. The hepatocyte (liver cell) incubation samples were turning into a hot potato.
For months, all the client was getting from its LC/MS system were half-baked results,
unable to usefully elucidate any of the metabolites.
Finally, the client contacted MicroConstants in San Diego, California. A pharmacokinetically-based
Contract Research Organization (CRO), MicroConstants is a company known for its scientific acumen
and cream-of-the-crop tools, specifically 16 Waters UPLC®
/MS/MS systems.
Turns out, liver cells were just their cup of tea.
The results in a nutshell: MicroConstants analyzed the samples, provided relevant peak heights,
product ion spectra, plus top-notch reproducibility revealing true metabolites. The icing on the cake?
MicroConstants also found many more metabolites and helped the client identify them.
They did it all in just one week’s time. Not unusual, really. MicroConstants’ managers have called
Waters ACQUITY UPLC®
the most reproducible chromatography they’ve ever seen in an LC. The qual-
ity of data and the remarkable turnaround time--hours instead of weeks--have raised the bar, making
competitive systems look like chopped liver.
MicroConstantsHEAR THE FULL STORIES AT W W W.WATERS.COM/CUSTOMERS
Asked to analyze liver cells, their system failed to bring home the bacon.
16. Pretty confusing, to say the least. But that’s the situation the pharmaceutical industry was facing with
the growing number of proprietary digital applications and standards in play.
That’s why the SAFE-BioPharma Association was formed. The goal: establish a global, interoperable,
digital identity and signature standard that would be recognized by regulatory and legal authorities
around the world.
In other words, everybody would be speaking one common language.
Waters Corporation is the first analytical instrument and software vendor to join in support of
the SAFE-BioPharma Association, whose goal dovetails perfectly with so many Waters products.
For example, Waters®
SDMS Vision Publisher is an analytical electronic laboratory notebook (ELN)
that allows analytical chemists to author documents, record observations, control procedures, and
find and collaborate on scientific results. The multiple approvals and processes required lend them-
selves to digital signing. SAFE-certified SDMS Vision Publisher will improve processes in the lab and
allow for fully electronic storage, retrieval and signature approval.
Net result: improved process time and improved efficiency.
Shows you what can happen once you get everybody speaking the same language.
Safe-BioPharma AssociationHEAR THE FULL STORIES AT W W W.WATERS.COM/CUSTOMERS
Imagine a conference call where everyone speaks a different language.
18. Engineering students are not chemists. But at the University of Massachusetts, Amherst, engineering
majors participate in an analytical experience normally reserved for chemists--conducting research
on water contaminants.
The engineers of tomorrow collect and analyze sensitive data using the latest in high performance
technology and equipment. A bit overwhelming, perhaps? Not really. Because the instruments in
the laboratories at UMass-Amherst are Waters instruments. So easy to use even wide-eyed
underclassmen quickly grow comfortable operating the most sophisticated pieces of technology,
like the ACQUITY UPLC®
System.
And with Waters equipment comes Waters professionals. When the students were recently faced with
a challenging study, a team from Waters came on campus to help. Patiently, they walked the students
through the methodologies, even suggesting alternatives in case of problems. In the end, an analyti-
cal perplexity that would have been a brain-bender for a laboratory full of highly trained chemists was
completed by a classroom of student engineers.
The hope of UMass-Amherst and Waters Corporation is that by involving students in this unique experi-
ence they become more attuned to the importance of water quality as both an environmental and pub-
lic health issue. And armed with that knowledge, the projects they develop in the future, be they civil or
environmental engineers, reflect what they learned in the classroom normally reserved for chemists.
University of Massachusetts-AmherstHEAR THE FULL STORIES AT W W W.WATERS.COM/CUSTOMERS
Chemist discovered inside engineering student.
20. Drug abuse. Drug misuse. Dangerous drug interaction.
The lone positive possibility? Compliance.
But if you think compliance is the norm, you’re in for a surprise. According to a national study,
75% of patients showed they may not be taking their pain medications as prescribed.
For physicians trying to develop the most effective treatment plan, this is a problem. Doctors need to
know if patients are taking their pain medications properly. So monitoring pain medications is vital.
Ameritox is the pioneer in the field, testing countless urine samples daily, and then getting complete
patient reports back to physicians when they need them. Their business depends on high quality and
rapid turnaround.
That’s why Ameritox depends on Waters instrumentation. Company executives have called Waters
chromatography as close to perfection as they’ve ever seen. The company has even converted several
of their GC/MS methods to UPLC®
/MS/MS methods because it’s quicker (less sample prep time);
it’s more productive (increased capacity in a smaller footprint), and it uses less amounts of
hazardous chemicals.
Waters is helping Ameritox help physicians achieve better patient outcomes.
AmeritoxHEAR THE FULL STORIES AT W W W.WATERS.COM/CUSTOMERS
When taking pain medications, there are four possibilities. Three of them are bad.
22. When the hopes of those stricken with a crippling illness are dependent upon your research, speed
becomes paramount. Lundbeck Research in New Jersey (USA) focuses on disorders of the central
nervous system such as Alzheimer’s, Parkinson’s, and stroke.
In their state-of-the-art laboratory, you’ll find an array of open access equipment from Waters. Easy-
to-use, high quality equipment that is as quick as it is robust. Like Waters ACQUITY UPLC®
system
that allows researchers to work twice as fast as ever before. So they can screen more compounds and
get more time points on biological experiments. UPLC®
not only delivers high quality data but a lot
more of it.
Lundbeck also utilizes MassLynx™ Software, Empower™ Software, and NuGenesis®
Scientific Data
Management System (SDMS) from Waters. Powerful individually, even more impressive linked, for su-
perior informatics synergy. With SDMS, the laboratory at Lundbeck Research is able to automatically
capture, secure, access, and disseminate information from any analytical technology. This instant
accessibility of information means stronger collaboration and more efficient operations.
The Lundbeck researchers know their task is a tall one, but they are determined; they are skilled; and,
with the help of Waters, they are swift.
Lundbeck ResearchHEAR THE FULL STORIES AT W W W.WATERS.COM/CUSTOMERS
For Alzheimer’s and Parkinson’s patients, the research can’t move fast enough.
24. Thanks to the outstanding work of their Waters equipment, the researchers from the Institute
of Genome Science and Policy at Duke University are filled with a lot of challenging questions.
You see, asking the right questions depend on getting the right data first. And that’s where
Waters liquid chromatography and mass spectrometry are second to none. By providing data
that is reproducible and quantifiable, it allows the scientists to ask more meaningful questions
about fundamental biology and proteins interaction.
For instance, is there a way to examine a sample of human tissue and:
n Determine whether a person is sick or not?
n Prevent an adverse drug reaction?
n Predetermine how that person will respond to a certain drug?
Any hope of answering these questions, and developing new ones, relies on data that is
reproducible. Whether it’s from one subject to the next or comparing differences between one
treatment group and another; data that is not reproducible means nothing. Data that is
reproducible is from Waters.
The questions are daunting. But with the quality of the results produced by Waters instrumenta-
tion, they should only lead to more groundbreaking answers.
Duke UniversityHEAR THE FULL STORIES AT W W W.WATERS.COM/CUSTOMERS
Sometimes you need answers before you can ask the right questions.