The Nebraska Medical Center Biologics Production Facility
Uploaded by NebraskaMedCenter on 05.01.2012
Transcript:
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.
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.