NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

This may be OT . . . or maybe not?

Merck KGaA acquires acoustic tech to industrialise cell therapy production
11-Oct-2019

Merck KGaA's MilliporeSigma has announced it has acquired Massachusetts-based FloDesign Sonics the developer of a unique acoustic cell processing platform for the industrialisation of cell and gene therapy manufacturing. Financial details of the deal have not been disclosed.

Udit Batra, member of the Merck Executive Board and CEO of Life Science explained that Chimeric antigen receptor T cell therapies (CART-T) employ the body's own immune systems to fight cancer by turning T cells into targeted therapeutics. This revolutionary cancer treatment is challenging and complex, with the process often taking up to a month.

Batra said: "Our acquisition of FloDesign Sonics will industrialise the manufacturing of autologous cell therapy, allowing these types of potentially life-saving treatments to reach more patients, faster."

Merck says it is the first company to make acoustic technology available for cell therapy manufacturing. Acoustic cell processing is a disruptive technology that allows for the manipulation of cells with ultrasonic waves. FloDesign Sonics' acoustic cell processing platform allows enhanced cell washing and concentration for manufacturing cell therapies.

The acquisition is a strategic fit for Merck, strengthening the ability alongside pharmaceutical manufacturers to advance cell-based therapies to patients.
"Merck is the best home for FloDesign Sonics, our acoustic cell processing technology and our employees," said Stanley Kowalski III, co-founder, Chairman and CEO of FloDesign Sonics.

Founded in 2009, the company develops an acoustic cell processing platform for cell and gene therapy applications. FDS just recently (Q1 2019) launched its first commercial product (Ekko) which allows the wash, concentration and formulation within Autologous CAR-T Manufacturing workflow.

Though there has been no relevant commercial revenue yet (2019: €0.8 million), the company has 52 granted patents and >200 applied.

https://www.manufacturingchemist.com/news/article_page/Merck_KGaA_acquires_acoustic_tech_to_industrialise_cell_therapy_production/158988



MilliporeSigma publishes white paper on single-pass tangential flow filtration
17-Sep-2019
https://www.manufacturingchemist.com/news/article_page/MilliporeSigma_publishes_white_paper_on_single-pass_tangential_flow_filtration/158197



Cell Therapy Manufacturing Update: Merck Becomes the First to Introduce Acoustic Technology
By Rohit Kumar October 22, 2019

With its acquisition of FloDesign Sonics earlier this month, Merck/MilliporeSigma has become the first company to introduce acoustic technology in cell therapy manufacturing. The acquisition of FloDesign Sonics is a strategic fit for Merck, strengthening its ability alongside to manufacture cell-based therapies for patients.

What is Acoustic Cell Processing: Acoustic cell processing is a disruptive technology that allows for the manipulation of cells with ultrasonic waves. FloDesign Sonics’ acoustic cell processing platform allows enhanced cell washing and concentration for manufacturing cell therapies.  As per an interview with FloDesign Sonics’ CEO, the platform leverages a patented 3D acoustic wave to manipulate cells and particles in suspension. This gentle, non-invasive technology effectively suspends target cells within standing waves in a chamber while material continuously passes through the chamber.

Advantage of Acoustic Cell Processing Over Traditional Approaches: The technology helps the manufacturers to achieve in one process that is traditional achieved separately through filtration, centrifugation, and cell selection. This helps in significantly reducing the time required in training and technology transfer.

What Other Companies are Using This Technology: FloDesign Sonics’ technology is currently being used by Pall Biotech, which offers a portfolio of scalable single-use technologies for continuous bioprocessing. The company’s platform is based on acoustic wave separation that can be used either for clarification of fed-batch cell culture or cell retention in perfusion cell culture.

Last year, FloDesign Sonics signed a technology development collaboration agreement with Cognate BioServices, a leading, CDMO, to advance the accessibility of life-saving therapeutics.  The aim of the collaboration was to advance the development of life-saving therapeutics by improving manufacturing efficiencies using FloDesign Sonics’ Acoustic Cell Processing (ACP) platform.

Applikon Biotechnology is another company that is using acoustic technology. According to the company, the Applikon BioSep system is a unique, cell retention device for high-density perfusion processes. The device uses high frequency resonant ultrasonic waves to separate cells instead of a physical mesh or membrane.  It, therefore, offers all the benefits of traditional devices but without their inherent problems and limitations. There are a few other companies that claim to be using acoustic technology.
How Does this Impact the Overall Cell Therapy Manufacturing Market? According to a report by Roots Analysis, the novel technologies being developed for cell therapies have the capability to save significant cost in the manufacturing of these therapies.

https://www.rootsanalysis.com/blog/2019/10/22/cell-therapy-manufacturing-update-merck-becomes-the-first-to-introduce-acoustic-technology/