BioSpherix

BioSpherix Reduces Risks for Cutting Edge Healthcare

Alicia D Henn, PhD, MBA

Alicia D Henn, PhD, MBA
Chief Scientific Officer, BioSpherix Ltd.

You are the CEO of a cellular therapy startup. You watch intently as your technician carefully unpacks the cell sample from your first patient. Your company could cure this patient by isolating the important cells, changing them, and growing them up in batches for treatments.

How precious are these cells? What are the risks to them and to your business?

The XVIVO™ System

Cellular therapies, which treat patients with improved cells and tissues rather than chemical drugs, are an entirely new approach to medicine and are offering hope to patients with diseases that range from arthritis to ALS to cancer. BioSpherix is dedicated to manufacturing products designed to best manipulate and grow these precious cells outside the body. The XVIVO System, a unique cell culture and processing system, reduces risks involved with regenerative medicine and cellular therapies while saving companies money and time.In addition to the XVIVO System, BioSpherix produces incubators, hoods, glove boxes, and other equipment to accommodate any cell need.

BioSpherix makes barrier isolators that reduce risks to cells while they are growing in the laboratory

The XVIVO barrier isolator completely encloses cell incubators as well as biosafety cabinet-like workspaces for all cell handling steps from start to finish. Cells are maintained in an unbroken, optimized environment with exquisite control of temperature and atmosphere. The isolator not only protects cells from suboptimal room-air conditions, but also from contaminants. Each isolator is constructed in modular units that are configured to the cell culture process, including operations that need FDA compliance. All cell processing equipment is enclosed and personnel perform cell handling through flexible glove-fronts.

BioSpherix XVIVO

BioSpherix builds modular XVIVO systems for FDA-approved clinical trials to protect cell cultures during all cell incubation and handling processes. Designed from the ground-up to go beyond the needs of people to the needs of cells, the XVIVO System maintains cells at constant body temperature and gas levels, protecting them from room air. Enclosing any needed equipment, the Cytocentric approach brings integrity to the entire cell production process. As cellular therapies move from experimental through clinical research stages, and equipment needs change, XVIVO modules can be easily added or modified without having to re-validate the entire system. This saves a tremendous amount of time and money, helping to speed new therapies to the clinic.

Reducing Risks to Regenerative Medicine

BioSpherix took their platform technology right into the surgical suite for ground-breaking regenerative medicine. An XVIVO system temporarily placed in the Children’s Hospital of Illinois grew a man-made trachea for a critically ill toddler using her own stem cells. At two years old, Hannah Warren made history as the youngest patient to receive this type of transplant. At birth, Hannah was unable to breathe, talk, swallow, eat, or drink on her own due to a congenital absence of a windpipe (trachea). The XVIVO Platform was crucial to the production of Hannah’s new trachea because it enabled doctors to manufacture the organ completely within the surgical suite. If the XVIVO System had not been used, the organ would have needed to be manufactured hundreds of miles away and transferred to the surgery location, exposing the organ to a great deal of risk. Shipped, installed and validated at an unprecedented speed, the XVIVO System was completely setup and functional within weeks.

Reducing Risks to Cellular Therapies

The XVIVO™ System is in use in several FDA-approved and Health Canada-approved cellular therapy clinical trials. Budd A Tucker, Associate Professor in the Department of Ophthalmology and Visual Sciences at the University of Iowa, is generating cells for retina transplantation from patient skin samples in an XVIVO™. This treatment holds tremendous promise for restoring sight to the blind.

At the Ottawa Hospital Research Institute, the Director of the Biotherapeutics Core Facility, Assistant Professor David Courtman, is using several XVIVO™ systems to generate several cell products for clinical trials. Gene-modified human endothelial progenitor cells are being produced for cellular therapy after a heart attack to repair the heart. Other cells are being produced for “first-in-man” clinical trial to cure pulmonary hypertension. They are also using an XVIVO to produce human mesenchymal stem cells for a clinical trial to save lives endangered by septic shock.

Biospherix trachea

An XVIVO System, designed and built by BioSpherix, was used in historic surgery to grow a man-made trachea for a desperately ill toddler from her own stem cells. Working in the protective XVIVO environment, doctors were able to seed her stem cells into the trachea support structure and grow them there, right in the surgical suite. The Cytocentric approach reduces risks to cutting-edge cellular therapies and regenerative medicine.

Reducing Risks to Companies on the Cutting Edge of Healthcare

As the CEO of that cellular therapy startup, you watch your technician move the patient sample into the XVIVO. You take a deep breath and relax. From this point on, the cells are in the best place possible outside of the body, optimized for each step in the protocol, before the cells go back to save or improve that patient’s life

Later, as you report to your investors, you tell them the modular nature of the XVIVO system means no money is wasted on phased-out equipment as the company grows. From pre-clinical studies through clinical trials, any changes in processing protocols will be easily accommodated. The sealed, modular nature of the XVIVO means that it can be reconfigured in weeks without the necessity of re-validating existing modules. Any system can be quickly replicated for expanded capacity. This flexibility saves time and money, accelerating the progress of cellular therapies.

BioSpherix brings a Total Quality Approach to cell incubation and handling, so that cellular therapies can reach the patients who need them most.

Visit the company website at www.biospherix.com for more information.

About the Author

Alicia Henn has been Chief Scientific Officer of BioSpherix for two years. Previously, she was a researcher at the Center for Biodefense Immune Modeling in Rochester, NY. Alicia obtained her PhD in molecular pharmacology and cancer therapeutics from Roswell Park Cancer Institute in Buffalo, NY and her MBA from the Simon School at University of Rochester in Rochester, NY.

About BioSpherix Ltd.

Headquarters: Parish, NY

BioSpherix specializes in CYTOCENTRIC™ technology, a new and better way to grow and manipulate cells in vitro. The XVIVO™ System is the first and only cell culture and processing system designed from the ground up to go beyond the needs of people to meet the needs of cells. Cytocentric-by-design eliminates the handicaps inherent in conventional equipment designed for people. BioSpherix also manufactures an extensive line of Cytocentric upgrades and accessories for conventional incubators, hoods, glove boxes, and other standard equipment to meet any cell need. BioSpherix has separate divisions for laboratory and medical applications. See the Cytocentric Principles Blog -www.biospherix.com/cytocentric.

NYS Employees: 60
Medical Website: www.biospherixmedical.com
LinkedIn: biospherix-medical
Twitter: @BioSpherixMD
Laboratory Website: www.biospherix.com
Twitter: @BioSpherix
Facebook: BiospherixLtd
LinkedIn: biospherix

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