The Nebraska Medical Center Biologics Production Facility

Biologics Production Facility is a multifunctional
laboratory. It is a production facility, which means our main purpose is to manufacture cellular
therapy products that will be given to patients. We can assist researchers in scaling up their
research ideas into a useable product and we can manufacture other things for a biotech
company. We also process fairly routine products that we give to patients every day in the
myro and stem cell transplant program. Jointly operated by The Nebraska Medical Center,
the region’s largest hospital, and the University of Nebraska Medical Center, the state’s
health science center and an international leader in health research, the Biologics Production
Facility opens new frontiers in research and patient care. In just a few hours this liquid, known as
storage media, will be part of someone’s cancer treatment.
We’ll put a little bit of this storage media in there and then we’ll take it over to
the patient. Then they will get those cells as part of their treatment for their cancer.
It’s a pretty neat little system. The methods used here bring the concept of
personalized medicine to an entirely new level. This laboratory makes that kind of bench top
to bedside translation possible because we can take what is essentially a research product
and make it, according to good manufacturing principles, so that we can actually safely
administer it to a patient. The vaccine or the cellular product can be
manufactured just for you so it can be targeted just against your malignancy for example or
the kind of problem that you have. It’s no ordinary laboratory. Every room
and every piece of equipment here was specially designed, built and installed with absolute
cleanliness in mind. The air in a standard laboratory wouldn’t
necessarily be controlled because the standard laboratory tests that you do, don’t really
require you have particularly clean air. The air in this facility, in some portions, is
a hundred times cleaner than in an operating room. There are filters at each entrance to
every room. If we have any open steps in processing, we do those under a biological safety cabinet
which is very clean. The reason for that is these are all products that patients are going
to get. They are going to get an infusion or an injection and we have to be very certain
that nothing contributes to contaminating these or cross contaminating one product with
somebody else’s product. All these products are unique. One product for one patient, so
it’s not like a bank or a laboratory, where you would have many units of blood for example
in a blood bank, and you would just cross match them and give them to an appropriate
patient. These are specifically designated, one product for one patient. As a facility that has various classifications,
we have class 100 thousand, we have class 10 thousand, our two million processing suites,
there is unique materials that are used. The GMP guidelines state that we have to have
materials in place from the lights, paint, flooring and they are all cleanable and prohibit
contaminations. There is nothing that can get in from exterior spaces, from the wall
space to the ceiling space, it is completely sealed.
The only thing that is supplied to this room is the air from the HEPA filtered air handlers
and then of course the exhaust. Right now, patients undergoing stem cell and
bone marrow transplants, for certain types of leukemia and lymphoma are directly benefiting
from the biologics production facility. I think this facility takes us to the next
level in all of those areas. It takes myro and stem cell transplants to the next level
of being able to use not only the transplant but the immune therapy and the other things
that go with it, to make outcomes better, decrease complications or to treat diseases
that were resistant before. New ground is being broken in the area of
solid organ transplant as well. Not every organ that is available for transplant is
suitable for transplant. Some of those could be used for making a suspension of the cells
that are important in that organ and that’s really the next step. It would also allow,
if we could grow these things up, to split an organ because we had a small recipient
or other ways to manipulate things. It allows us to take that next step. When it comes to the future, the sky is the
limit. Hopefully in the future we can do more new
things. I think the standard products that we have been making for a long time are very
helpful for many patients but that’s not really the future of transplantation or immune
therapies. I see that there will be a lot more diseases that could be treated with products
or vaccines that could be manufactured here. It’s pretty much limitless.

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