Targeted BioSystems, LLC

​Targeted BioSystems, LLC                                                          

Driving Innovations

Technologies

Targeted BioSystems, LLC has developed new approaches for cell specific selection and expansion.  Our team is developing cryo-preserved, off the shelf biologics for research use specific to autoimmune diseases incurable.  We have developed patents pending closed system bioreactors with specific designs for specific research needs


One example of FDA regulated cellular immunotherapy removes a patient's mononuclear cells by apheresis, manipulates these cells

with growth  factors and cytokines, expandes these cells and under approved INDs are returned to the patient's body as renewed

disease fighting cells.  Targeted BioSystems, LLC is improving this process by providing next generation closed-system

bioreactors

​New bioreactor concepts:
It’s clear that technological advancements are evolving exponentially.   Bioreactors in the 1950s and early 1960s were test tubes and shakers with advancements of plungers and gear pumps and screw top jars.  Today there is a multiplicity of various bioreactors, big and not so big, but they are designed to do a certain job. Science knows that people’s immune systems have common denominators, but their immune systems are still unique.  Every cancer, even with their common denominators, carries unique problems.  By definition personalized medicine is unique to a patient, and Targeted BioSystems, LLC. has a clear goal to make personalized disposable bioreactors for a specific purpose, one being, to treat cancer.

Improve Existing Products: 
Our objectives are many, centered first on producing research grade biologics translatable for future clinically approved cellular immunotherapies for the treatment of many of the eighty plus autoimmune diseases.  This will be accomplished from our patents pending technologies for expanding specifically derived mesenchymal stem cells to treat autoimmune diseases and tissue repair.  Another objective is to keep a patient’s cancer cells alive in a bioreactor for study of customized cancer patient treatment vaccines.  There is a need for safe bioreactors to make lentiviruses for gene modification of mal-functioning cells. It would be great if we could make one large bioreactor that makes living cells to treat every cancer with universal cellular immunotherapy; something like the chemotherapeutic model.  Unfortunately that doesn’t exsist today since everyone and every cancer is still unique. Chemo is an accepted front-line approach, but not perfect in every way.  For the safety and betterment of our health, doctors and hospitals have converted to single-use disposable products where possible.  Targeted BioSystems, LLC. is familiar with the technology to make personalized cancer therapy a viable and disposable possibility. Within our reach we can make bioreactors to grow autologous (one’s self) immune cells to “mop up” residual cancer cells that often hide in the patient’s body after surgery, radiation, or chemotherapy.  Still in the research stage, our multi-functional bioreactors will have the ability to trigger each patient’s immune cells to attack the identifying properties (surface markers) of the unique cancer cells.  This occurs while the live cells are outside of the patient’s body.  Within the bioreactor clinicians “teach” the immune cells to find and kill the cancer cells that they have been missing.  They will be re-infused to the patient to go on a mission to seek and destroy those invading and evading cancer cells, wherever they may be hiding.

Enhance Treatment Strategies:
Cellular immunotherapy is the future for cancer treatments, both leukemia’s and solid tumor types, auto-immune diseases, osteopathic arthritis, perhaps even aging. Everyone’s immune system has unique qualities and every cancer type brings unique problems.  A drug for one type of lung cancer may have little affect on another patient’s lung cancer.  By definition personalized medicine is unique to a patient. Targeted BioSystems, LLC. is comprised of a team of Ph.Ds, medical doctors, bioengineers, and marketing specialists all trained and seasoned in the emerging field of cell therapy. With today’s medicine doctors are readily able to retrieve a patient’s immune cells by multiple means. From biopsies they can get a patient’s cancer cells. Cellular therapy is in use now, with one form cleared by the FDA for human use in prostate cancer.  There are numerous approved IND patient studies. To prove the degree of interest in cellular immunotherapy:

  • In September, 2017 Gilead bought Kite Therapeutics for $11.9 Billion dollars. 
  • In October, 2017 Novartis and the University of Pennsylvania ended one study that was successfully approved to treat ALL and then extended to a multi-million dollar investment again at University of Pennsylvania by creating a spin-off funded by others for $100 Million dollars called Tmmunity.
  • In January, 2018 Celegene bought Juno Therapeutics for $9.1 Billion dollars.
  • Our team knows these companies and many others.  There is interest in our simpler systems and cost savings approach. 
  • The current Car-T protocols are very expensive to the patients and can cost in the range of $450,000.00 per patient.  For reference an average bone marrow transplant costs $800,000.  Much of the cost of CAR-T cells is borne by the production of virus particles needed to transfect the patient’s T-cells.  We have a bioreactor under study to address this costly issue.

There are many more biotech company examples with many more achievements to come.  Academic universities in the US and globally are also working to advance the science.  Reducing cost and simplifying protocols are on everyone’s mind.  We can help.
 
Customized Bioreactor Designs:
So what makes our bioreactors better than a screw top jar?  To start with they will be classified as “closed system”, meaning contaminants like bacteria and germs can’t get into the bioreactor.  On its own this is a very important factor for safety, but alone this could result as well in substantial laboratory cost savings. Under research, our bioreactors can select the very specific immune cells that are likely to be the ones to kill off a patient’s remaining cancer cells while it will dispose of the unwanted cells.  The wanted cells can be matured and expanded in our bioreactors and once they become a fighting force they get returned to the patient.  Our single use system provides substantially lower costs and therefore can make patient treatments more broadly available to patients.

Conclusion:  This is one approach for cancer therapy; it’s how we will help to “mop up” cancer. We are aggressively working to multiply undifferentiated MSCs for the eventual treatment of autoimmune diseases.  The overall approaches are called cellular immunotherapy of which some of these therapy types are clinically cleared by the FDA and used in many settings globally.  We will improve on the existing technology markedly with our research generation of bioreactors.  The bioreactors we have designed have patents pending and will be going into the therapeutic research market, not only for treatment of autoimmune diseases but also cancer and diagnostic testing of a patient’s living cancer cells.​

Experience

Knowledge

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