BioSpherix Medical

BioSpherix Medical

BioSpherix Medical
Exhibitor Spotlight

INTERPHEX created a quick questionnaire to learn more about BioSpherix Medical In this exhibitor spotlight, Randy Yerden, answers our questions.

INTERPHEX: - Tell us how your company started.

Founder was cloning stem cells in 1976 as grad student. The cells didn’t grow very well. He invented an incubator upgrade that simulated physiologic conditions, and the cells grew much better. He started his one-man business manufacturing the upgrade for others in 1982, and over the next 19 years developed many additional specialized devices and procedures under contract for leading cell scientists to meet the needs of their cells. When he realized these were tools everybody would eventually need, everybody serious about cells, he formed BioSpherix in 2001. Shortly thereafter he established Cytocentric Principles® as the first quality framework for cells outside the body. The company continues to grow as cells become more valuable, and more segments in the new live cell industry embrace quality.

INTERPHEX: - How has your company evolved into what it is today?

INTERPHEX: - How has the industry changed/evolved?

In the old days there was no live cell industry. When I started in cell research in 1975 cells were cheap and easily obtained and casually discarded and routinely lost to contamination. Then a few commercial suppliers of cells arose that put a dollar value on them. Then bone marrow transplants and in vitro fertilization started to amplify the clinical value of cells beyond the first cell therapy – blood. Genetically engineered cells became valuable because they were expensive to create and brought new industrial capability to biologics production. Stem cells and other types of cell therapies with incredible life saving potential came into development, and cell-based assays became the new gold standard for drug development and toxicity testing. Most of this happened in the last 20 years, and indeed now there is a substantial industry, I call “the live cell industry”, with accelerating and long term growth ahead.

INTERPHEX: - Can you describe three aspects that have allowed your company to succeed?

INTERPHEX: - What is your company’s biggest success thus far?

INTERPHEX: - What is your biggest success thus far?

INTERPHEX: - What distinguishes your company from others in the industry?

All the other companies that design and sell equipment for incubating, processing, and producing cells seem to focus on the people who are their customers, not the cells. We call them “people- centric” in contrast to our unique approach we call “Cytocentric®”. We design to meet the needs of the cells, confident the people who care about quality cells will follow. For example, their advertisements tout the ease of decontaminating the incubator, instead of eliminating contamination risk like we do. They tout the quick recovery after the incubator door is closed, instead of eliminating the suboptimal transients in the first place like we do. They tout the consistency of color coordination among their incubators, refrigerators, freezers, and centrifuges instead of the consistency of the cells and the data generated from the cells like we do.

INTERPHEX: - What is the biggest challenge in your industry?

In the regulated industries of cell therapy and biologics, the resistance to innovation is scandalous. The old legacy GMPs of absolute, rules-based, dogma is stifling many innovations that could lower costs, speed development, and reduce risks on multiple levels. Our innovation is the perfect example. Our Cytocentric Modular Closed Aseptic Containment System does just that. It lowers costs. It speeds development. It reduces risk on many levels, especially risk to the patient! It produces the best quality cells possible, yet it is so different from what is tried and true that most are afraid of it. How can 100% of the touch-points with regulatory agencies result in approval, but 99% of the GMP consultants and GMP experts are too timid to even consider it? Even though modern science-based, risk-based, evidence-based 21st Century GMPs promoted by the regulatory agencies is the key to facilitating innovation, most GMP consultants and GMP experts still just give it lip service.

INTERPHEX: - Where do you see the industry going in the next 10 years?

INTERPHEX: - What would you consider to be a major achievement for the industry in the coming years?

In cell therapy, the indisputable success of curing childhood leukemia has finally brought all the big boys into the game. The next milestone achievement will be to confirm the inevitable lowering of COGs as efficiency and innovation work their magic in the marketplace. This will bring the benefits to the masses, and hopefully silence the naysayer pundits.

INTERPHEX: - What advice would you give to a professional starting out in the industry that you wish you would have known?

INTERPHEX: - What don't most people realize about you or your company?

INTERPHEX: - What is your favorite INTERPHEX memory?

INTERPHEX: - Can you describe how you have grown your business at INTERPHEX events?

INTERPHEX: - What are you looking forward to at INTERPHEX this year?

We are looking forward to introducing our Cytocentric® innovation to the attendees, especially since cell and gene based therapy are now finding a new home on the exhibit floor.

INTERPHEX: - Is there anything that you would like to specifically see at INTERPHEX 2019?

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