Recent Clients

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Posted - May 8th, 2017 

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 cleveland clinic logo

"The BioSpherix Medical's Xvivo enables us to control and monitor critical environmental parameters for our cell culture recipe optimization platform. Our platform merges developmental biology and stem cell biology with cutting edge hardware instrument technology, and computerized experimental design and analysis, to create industrial ready manufacturing methods for cell therapy. The ability to add many different modules together allows us to isolate our instrumentation and provide a flexible workflow for our Quality-by-Design methods. BioSpherix's process analytical technology (PAT) is useful in project monitoring, supply consumption and troubleshooting. We have used this system since 2013 and highly recommend it for cell culture both in commercial and academic institutions. For those looking to create a GMP cell culture facility, I suggest comparing the XVivo to a cleanroom environment and noting this cost and time savings for installation and future operations."

- CEO Michael Gilkey, MS, MBA
www.trailbio.com

 

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 Posted - April 27th, 2017

tischms

Tisch MS Research Center of New York is excited to announce the construction of the new Institute for Regenerative Cell Therapy, which will include multiple state-of-the-art cGMP cell production facilities (Xvivo Isolator Systems). The systems will be used in phase II trials to confirm efficacy of the use of stem cells as a repair strategy treatment in patients with progressive Multiple Sclerosis (MS).

Work conducted by Dr. Sadiq and Dr. Violaine Harris led to a very successful phase I clinical trial, the only one of its kind in the United States, to test the safety and tolerability of intrathecal transplantation of autologous MSC-NP cells in patients with progressive MS, which led to a required increase in capacity to manufacture the cells .

Tisch MS has turned to BioSpherix Medical to supply the leading edge equipment needed for their new institute.  With its modular design and unlimited scale up/scale out capabilities, the Xvivo System was an obvious choice as their cell manufacturing needs increased. In addition to providing a cell optimized, aseptic GMP compliant work environment, the isolators are quicker to implement than conventional open cleanrooms, eliminating the risks of delay for new construction and open cell processing.

BioSpherix is proud to work with yet another exciting regenerative medicine institute, Tisch MS Research Center of New York, as their groundbreaking work unfolds.

http://www.tischms.org/

 

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  Posted - April 14th, 2017

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Thanks to BioSpherix Medical's industry leading experience in providing customized Cytocentric isolators worldwide, BioSpherix was recently chosen as the supplier of choice in providing a modular GMP isolator (cleanroom alternative) for one of the top biopharmaceutical companies developing cellular therapy for diabetes: Semma Therapeutics.

Cambridge-based Semma is built on research that came out of Doug Melton's laboratory at the Harvard Stem Cell Institute , and now focuses on developing a delivery system and method of creating transplantable stem cells as a possible cure for Type 1 diabetes.

BioSpherix Medical is tasked to create a highly customized, modular isolator with an 'ISO-5 / class A' environment whilst optimizing and safeguarding the cell product and machine automation enclosed. The unique BioSpherix GMP isolators offer a total quality approach to cell-based production, with full-time monitoring and control of all critical cell process parameters such as temperature, CO2, O2, RH, pressure, particles, etc. We look forward to working with yet another successful cell therapy company, poised to revolutionize the health of millions in this exciting field of regenerative medicine.

http://www.semma-tx.com/

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