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Samsung BIO Insight
Building a transformative partnership in drug development
How Samsung Biologics’ streamlined processes, dedicated project
management,
and proprietary platforms can pave the way for drug development
success
Christina Lorentz, left, Director of
Clinical Operations at Aronora, and Brandon Markway, right, Director of Chemistry, Manufacturing and
Control at Aronora, at Samsung Biologics’ headquarters in Songdo, South Korea.
While technical expertise, quality resources, and
flexibility are all fundamental to cell line development, a core component of the process is reliable
collaboration. The right cell line development partner can help biotech companies rise above the complexity
to deliver high productivity and maintain high cell viability, which is critical to maximizing the
likelihood of advancing the project.
Aronora Inc., a clinical-stage biotechnology company
developing next-generation therapeutics for blood clotting diseases, partnered with Samsung Biologics to
ensure its development success.
Selection centered around quality and
expertise
Based in Portland, Oregon, Aronora is currently
undergoing clinical development for Gruticibart, a recombinant monoclonal antibody (mAb) that is
specifically designed to treat and prevent blood clots (thrombosis), without causing increased bleeding
risk.
To build a baseline for success and advance their
molecule, Aronora’s team sought to collaborate with a CDMO that has experience in developing viable cell
lines with a high titer, a gram-per-liter concentration of viable antibodies extracted from a
bioreactor.
“When selecting a partner for this product, we needed
someone with experience developing mAbs and a good reputation for quality,” said Christina Lorentz, Ph.D.,
Director of Clinical Operations at Aronora. “What made the difference was Samsung Biologics’ expertise in
the antibody space–this was ultimately the biggest driver in the CDMO selection process. The Samsung
Biologics’ team also instantly understood our specific needs and were wholeheartedly collaborative
throughout the entire process.”
Advanced solutions to achieve a high-titer cell
line
Acquiring a high-titer cell line is a cornerstone for
successful drug development. It means the cell line has a high-concentrated antibody that neutralizes
antigens, or target viruses, giving it more potential to become a commercialized drug. Through its
partnership with Samsung Biologics, Aronora was able to take the right step to advance its molecule while
saving time and cost.
Before partnering with Samsung Biologics in 2022,
Lorentz said Aronora had a cell line with “a very low titer that was essentially not commercially viable,”
adding that redesigning its cell line helped to revitalize the development program and give Aronora momentum
as they move toward commercial manufacturing.
“It’s extremely important to the viability of the
program to be able to generate a sufficient amount of antibodies for a certain amount of money,” she said.
“If your titer is low, you have to run these giant bioreactors – which is expensive – just to get a small
amount of antibodies.”
Samsung Biologics’ proprietary platform¬ S-CHOice®
helped to steer Aronora’s development, while minimizing risks. Enhanced by a know-how of utilizing
methionine sulfoximine in cell line development, S-CHOice® generated a cell line with a nearly tenfold
amount of titer than what Aronora’s previous cell line had.
Recalling the moment Lorentz learned of the high level
of titer S-CHOice® brought to the new cell line, she said cell line developers at Samsung Biologics
essentially energized the program.
“If cell line development fails, then the whole program
has a risk of failing,” she said. “So knowing our new cell line has a high titer means the program has
regained significant momentum.”
A trusted partner offering seamless
communication
Close-knit communication is also imperative when it comes to
collaborating on a project like cell line development. Lorentz, who also manages numerous projects at Aronora,
found the enthusiasm and openness of Samsung Biologics’ project managers invaluable.
“The project managers at Samsung Biologics were very
proactive with communication and responsive to our requests,” Lorentz said. “They always followed up to ensure
that nothing fell through the cracks.”
Samsung Biologics’ strong technical expertise, resources,
and flexibility in cell line development have been key to advancing clients’ drug candidates.
“Cell line development is the foundation for everything,”
said Lorentz. “One of the best things about this collaboration has been Samsung’s experience going from cell
line development all the way to commercialization. As a small company, we have really benefited and learned a
lot about the entire process as opposed to just looking at it piece by piece. We are truly in good hands with
Samsung.”
Successful development relies on a deep understanding of a
molecule’s unique characteristics as well as an open, collaborative environment driven for success. Samsung
Biologics has the knowledge and expertise to realize the true potential of a client’s molecule, regardless of
its complexity. For more information on our cell line development services, please reach out to our experts at
Samsungbiologics.com/contact-us
Related Contents
Samsung BIO Insight Exploring Samsung BiologicS' CDO capabilities | Bispecific antibodies
How Samsung
Biologics’ streamlined processes, dedicated project management,
and proprietary
platforms can pave the way for drug development success
Christina Lorentz, left, Director of
Clinical Operations at Aronora, and Brandon Markway, right, Director of Chemistry, Manufacturing and
Control at Aronora, at Samsung Biologics’ headquarters in Songdo, South Korea.
While technical expertise, quality resources, and
flexibility are all fundamental to cell line development, a core component of the process is reliable
collaboration. The right cell line development partner can help biotech companies rise above the
complexity to deliver high productivity and maintain high cell viability, which is critical to
maximizing the likelihood of advancing the project.
Aronora Inc., a clinical-stage biotechnology
company developing next-generation therapeutics for blood clotting diseases, partnered with Samsung
Biologics to ensure its development success.
Selection centered around quality and
expertise
Based in Portland, Oregon, Aronora is currently
undergoing clinical development for Gruticibart, a recombinant monoclonal antibody (mAb) that is
specifically designed to treat and prevent blood clots (thrombosis), without causing increased bleeding
risk.
To build a baseline for success and advance their
molecule, Aronora’s team sought to collaborate with a CDMO that has experience in developing viable cell
lines with a high titer, a gram-per-liter concentration of viable antibodies extracted from a
bioreactor.
“When selecting a partner for this product, we
needed someone with experience developing mAbs and a good reputation for quality,” said Christina
Lorentz, Ph.D., Director of Clinical Operations at Aronora. “What made the difference was Samsung
Biologics’ expertise in the antibody space–this was ultimately the biggest driver in the CDMO selection
process. The Samsung Biologics’ team also instantly understood our specific needs and were
wholeheartedly collaborative throughout the entire process.”
Advanced solutions to achieve a high-titer cell
line
Acquiring a high-titer cell line is a cornerstone
for successful drug development. It means the cell line has a high-concentrated antibody that
neutralizes antigens, or target viruses, giving it more potential to become a commercialized drug.
Through its partnership with Samsung Biologics, Aronora was able to take the right step to advance its
molecule while saving time and cost.
Before partnering with Samsung Biologics in 2022,
Lorentz said Aronora had a cell line with “a very low titer that was essentially not commercially
viable,” adding that redesigning its cell line helped to revitalize the development program and give
Aronora momentum as they move toward commercial manufacturing.
“It’s extremely important to the viability of the
program to be able to generate a sufficient amount of antibodies for a certain amount of money,” she
said. “If your titer is low, you have to run these giant bioreactors – which is expensive – just to get
a small amount of antibodies.”
Samsung Biologics’ proprietary platform¬ S-CHOice®
helped to steer Aronora’s development, while minimizing risks. Enhanced by a know-how of utilizing
methionine sulfoximine in cell line development, S-CHOice® generated a cell line with a nearly tenfold
amount of titer than what Aronora’s previous cell line had.
Recalling the moment Lorentz learned of the high
level of titer S-CHOice® brought to the new cell line, she said cell line developers at Samsung
Biologics essentially energized the program.
“If cell line development fails, then the whole
program has a risk of failing,” she said. “So knowing our new cell line has a high titer means the
program has regained significant momentum.”
A trusted partner offering seamless
communication
Close-knit communication is also imperative when
it comes to collaborating on a project like cell line development. Lorentz, who also manages numerous
projects at Aronora, found the enthusiasm and openness of Samsung Biologics’ project managers
invaluable.
“The project managers at Samsung Biologics were
very proactive with communication and responsive to our requests,” Lorentz said. “They always followed
up to ensure that nothing fell through the cracks.”
Samsung Biologics’ strong technical expertise,
resources, and flexibility in cell line development have been key to advancing clients’ drug
candidates.
“Cell line development is the foundation for
everything,” said Lorentz. “One of the best things about this collaboration has been Samsung’s
experience going from cell line development all the way to commercialization. As a small company, we
have really benefited and learned a lot about the entire process as opposed to just looking at it piece
by piece. We are truly in good hands with Samsung.”
Successful development relies on a deep
understanding of a molecule’s unique characteristics as well as an open, collaborative environment
driven for success. Samsung Biologics has the knowledge and expertise to realize the true potential of a
client’s molecule, regardless of its complexity. For more information on our cell line development
services, please reach out to our experts at Samsungbiologics.com/contact-us
Related
Contents