Waters and Sartorius Partner to Help Bioprocess Scientists Accelerate Clone Selection and Process Development
October 27 2021 - 8:00AM
Business Wire
News Summary:
- Collaboration to combine the Waters™ BioAccord™ LC-MS System as
a bioprocess analyzer with the Sartorius Ambr® bioreactor system
gives bioprocess scientists both faster and direct access to
advanced quality characterization information.
- Combination to accelerate turnaround time for robust data about
critical quality and cell culture media attributes by several
weeks, aiding bioprocess scientists in clone selection and process
development.
- Companies to collaborate on opportunities for adapting
analytical mass spectrometry methods to new modalities and
incorporating its use in bioprocess monitoring, process control and
Critical Quality Attribute (CQA) measurement.
Waters Corporation (NYSE: WAT) and Sartorius (DAX: SRT:GR)
announced today they will partner to provide bioprocess experts
with direct access to high-quality mass spectrometry (MS) data to
accelerate the speed and improve the accuracy of biopharmaceutical
process development. Sartorius and Waters will partner to implement
the BioAccord™ LC-MS System from Waters as a new bioprocess
analyzer with data connectivity to Sartorius’ Ambr® multi-parallel
bioreactor systems to deliver mass spectral information on drug
substances, related analytes and cell culture media. This
combination will greatly accelerate and improve the accuracy and
speed of tasks from clone selection to bioprocess optimization.
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At a ~10% CAGR from 2020 to 2025, biopharmaceuticals is the
fastest-growing segment of the overall pharmaceutical market,
according to a report by Evaluate Pharma. Fueling this growth is
the unprecedented rate at which highly complex new biologics are
coming to market. As a consequence, biopharmaceutical manufacturers
are requiring more upstream analytical data than ever about drug
product attributes and bioprocessing efficiency to enable the
development of new, better, and more affordable medicines.
“Waters and Sartorius share a commitment to biopharmaceutical
customers to solve their problems with the very best process and
analytical tools,” said Davy Petit, Senior Director of Global
Pharmaceutical and Biomedical Research Business, Waters
Corporation. “Clone selection and process development can benefit
significantly from at-line versatile mass spectrometry data which
can help bioprocess engineers accelerate workflows and increase
confidence in making critical decisions. The combination of our
technology in the hands of bioprocess scientists, alongside the
well-established Sartorius Ambr bioreactor systems installed-base,
can significantly reduce the development timeline for delivery of
medicines and vaccines.”
“The combination of Ambr and the easy-to-use at-line Waters
BioAccord LC-MS System will save bioprocess scientists substantial
time and accelerate clone selection and upstream process
development,” said Mario Becker, Head of Product Management Cell
Culture Technologies at Sartorius. “The closer we can bring
fundamentally important MS data to the point where it is needed,
and the more Ambr samples that can be tested for quality
attributes, the better we can provide bioprocess scientists a more
complete picture of drug product quality at any point during
cell-line, media, and process development. Eventually, we can
envisage such process control, monitoring and product quality
testing being fully integrated into the manufacturing
environment.”
Fast Access to Mass Spectrometry Data for Those Who Are Not
Mass Spec Experts
Biological drugs are made by living cells in bioreactors like
the Sartorius Ambr high throughput bioreactor system. At the
conclusion of the cell culture process, the proteins are separated
from the cell residue and samples are sent to a central laboratory
to await testing by analytical scientists using specialist liquid
chromatography-mass spectrometry (LC-MS) instruments. It’s not
uncommon for the process to stretch across 2-4 weeks or more
depending on the workload, equipment availability, priorities, and
staffing levels of the central analytical laboratory.
The combined offering from Sartorius and Waters aims to shorten
the process from what can take over a month to two days or less,
while giving more control to bioprocess scientists to obtain robust
mass spectrometry data for drug substance and cell culture media
samples. The industry-leading range of Sartorius Ambr
multi-parallel bioreactors has been developed to take scientists
through the early steps of their upstream process from cell
selection, through to process optimization. The Waters BioAccord
System is a small footprint LC-MS instrument designed as an
easy-to-operate, at-line benchtop bioprocess analyzer. Its
pre-defined analytical methods, guided workflows, auto-calibration,
and auto-tuning features allow those without any mass spectrometry
experience to obtain high-quality mass spectral data within
minutes.
Availability
Interested customers can contact both Waters and Sartorius:
- Waters Corporation contact: John_Gebler@waters.com
- Sartorius contact: Ian.Ransome@Sartorius.com
Additional Resources
- Learn more about the Sartorius-Waters collaboration
- Learn more about the Waters BioAccord System with ACQUITY
Premier
- Learn more about Sartorius Ambr multi-parallel bioreactor
systems
About Sartorius (www.Sartorius.com)
The Sartorius Group is a leading international partner of life
science research and the biopharmaceutical industry. With
innovative laboratory instruments and consumables, the Group’s Lab
Products & Services Division concentrates on serving the needs
of laboratories performing research and quality control at pharma
and biopharma companies and those of academic research institutes.
The Bioprocess Solutions Division with its broad product portfolio
focusing on single-use solutions helps customers to manufacture
biotech medications and vaccines safely and efficiently. The Group
has been annually growing by double digits on average and has been
regularly expanding its portfolio by acquisitions of complementary
technologies. In fiscal 2020, the company earned sales revenue of
some 2.34 billion euros. At the end of 2020, nearly 11,000 people
were employed at the Group’s approximately 60 manufacturing and
sales sites, serving customers around the globe.
About Waters Corporation (www.waters.com)
Waters Corporation (NYSE:WAT), the world's leading specialty
measurement company, has pioneered chromatography, mass
spectrometry, and thermal analysis innovations serving the life,
materials, and food sciences for more than 60 years. With more than
7,400 employees worldwide, Waters operates directly in 35
countries, including 14 manufacturing facilities, and with products
available in more than 100 countries.
Waters and BioAccord are trademarks of Waters Corporation.
Sartorius and Ambr are registered trademarks of Sartorius AG and/or
its affiliated companies.
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version on businesswire.com: https://www.businesswire.com/news/home/20211027005326/en/
Media:
Waters Corporation Brian J. Murphy PR Manager, Corporate
Communications brian_j_murphy@waters.com +1 508-482-2614
Sartorius Jason Jell Head of Marketing Communications BPS
BPSTradeMedia@Sartorius.com
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