Donaldson Announces Integrated Lentiviral Vector Manufacturing Platform Development
May 08 2024 - 11:35AM
Business Wire
The first phase of a multi vector
manufacturing platform solution
Donaldson Company, Inc. (NYSE: DCI), a leading worldwide
provider of innovative filtration products and solutions, announced
its Isolere Bio (Isolere) and Univercells Technologies businesses
are developing an integrated upstream and downstream platform for
viral vector manufacturing. The first phase will focus on
lentivirus (LV) manufacturing, concentrating on improving
recoveries with a scalable process while keeping the manufacturing
footprint small.
“This manufacturing platform promises to establish a solution
that accelerates process development timelines and reduces
manufacturing complexity in the production of accessible cell and
gene therapies worldwide,” said Andrew Dahlgren, Donaldson Life
Sciences president.
Univercells Technologies’ scale-X™ fixed-bed bioreactor has
demonstrated high yields of infectious LV in perfusion mode.
Isolere’s IsoTag™ LV affinity purification reagent enables
non-chromatographic purification of LV vectors with high functional
recoveries, high purity, decreased unit operations and reduced
total processing time. The IsoTag LV reagent confers additional
stabilizing properties to the LV vectors that may be advantageous
when used in conjunction with the scale-X bioreactor.
“For the first phase of the manufacturing platform, we are
starting with LV given the growing demand for this vector, as
current infectious virus recoveries are low and the virus is
unstable,” said Kelli Luginbuhl, Isolere’s founder and general
manager. “Achieving extended, low-shear perfusion culture in the
scale-X bioreactor platform, together with the IsoTag LV’s in situ
virus stabilization, will improve yields and lower costs.’’
Isolere’s pipeline of IsoTag reagents currently is focused on
offering affinity purification solutions for adeno-associated virus
(AAV), LV and positive-strand RNA viruses (ssRNA). These reagents
combine tailored affinity ligands with liquid-liquid phase
separation to sequester target biologics from complex solutions
into large droplets. These droplets are concentrated and purified
via tangential flow filtration using familiar equipment and
off-the-shelf consumables.
Mathias Garny, Univercells Technologies’ general manager, said,
“scale-X technology is a demonstrated bioreactor platform for rapid
process development and scale-up of virus manufacturing. The design
of the scale-X fixed-bed enables extended low-shear perfusion
operation as well as significant reductions in host cell proteins
and host cell DNA. Unlike other bioreactors, both suspension and
fixed-bed, this bioreactor is directly scalable from bench to
commercial-scale. It is now in use at CDMOs worldwide for clinical
trial manufacturing, and the first commercial product produced in
the scale-X bioreactor will launch later this year.”
“Donaldson is a new entrant into the bioprocessing space, having
made selective and strategic acquisitions over the past three
years,” added Dahlgren. “A key element in our strategy is to
acquire innovative companies such as Isolere and Univercells
Technologies that together can make a significant difference in the
manufacturing of complex biologics, increasing the availability of
these life-changing medicines worldwide.”
About Donaldson Company
Founded in 1915, Donaldson (NYSE: DCI) is a global leader in
technology-led filtration products and solutions, serving a broad
range of industries and advanced markets. Diverse, skilled
employees at more than 140 locations on six continents partner with
customers - from small business owners to R&D organizations and
the world’s largest OEM brands. Donaldson solves complex filtration
challenges through three primary segments: Mobile Solutions,
Industrial Solutions and Life Sciences. Additional information is
available at Donaldson.com.
About Donaldson
Bioprocessing
Donaldson Bioprocessing is dedicated to advancing
biopharmaceutical technologies through its subsidiaries of Isolere
Bio and Univercells Technologies, among others. Isolere Bio
specializes in IsoTag™ reagents and filtration processes for
streamlined biopharmaceutical manufacturing, while Univercells
Technologies focuses on innovative biomanufacturing solutions for
cell and gene therapy research and commercial manufacturing. For
more information, visit IsolereBio.com and UnivercellsTech.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20240508611521/en/
Sarika Dhadwal (952-887-3753) Sarika.Dhadwal@Donaldson.com
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