Research at The Nebraska Medical Center Biologics Production Facility

Uploaded by NebraskaMedCenter on 28.12.2011

The Biologics Production Facility, at the University of Nebraska Medical Center, provides
new state of the art ultra clean room laboratories designed to meet good manufacturing practices
or GMP regulations. Operated jointly by UNMC and its hospital partner, The Nebraska Medical
Center, the facility produces blood and cell products used in patient care. When it comes
to research, the possibilities are almost limitless.
This really is a unique place. The nearest one like this is probably in Minneapolis at
the University of Minnesota. So many big cities and many large Universities would have something
similar. The one thing that distinguishes us is our ability to cooperate amongst the
different disciplines. We have one quality system and we have one quality unit that controls
the facility. We can work with various researchers, if they are working with solid organs, livers
and pancreas or if they are working with liquid products such as bone marrow or peripheral
blood stem cells. All of these products need to be handled slightly differently and we
can manage them through many different clean rooms and a cooperative system without duplicating
the quality unit in particular.
That quality unit applies to all projects within the facility. It includes controlled
access, personnel, training, documentation, production and process controls. All the equipment
housed in the facility is covered by a building-wide 24/7 equipment monitoring system. The facility
houses clean rooms capable of class 100 thousand to class one hundred air quality.
The GMP guidelines state that we have to have materials in place from the lights, paint,
flooring and that they are all cleanable and prohibit contaminations. A class 10 thousand
facility that we are in right now, the floor is not linoleum or vinyl based flooring. This
is actually a resin-based, sealed directly over concrete. There is no vinyl flooring
as opposed to a class 100 thousand that we have downstairs, we have vinyl in that area.
It transitions from the floor to the wall in a continuous resin-based paint surface.
You’ll notice that we have hard deck flat ceilings in here instead of a drop tile or
gasketed ceiling like downstairs. Of course we have stainless steel diffusers for all
of our terminal HEPA filters. These types of HEPA filters are rated at 99.99 percent
efficiency for particles of .03 microns and greater. All the lights are all sealed and
gasketed so they are all cleanable surfaces. 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.
We have a lot more capacity here than we are currently using. We have six clean rooms and
we have a separate suite, this one single clean room is almost a mini GMP facility all
by itself that’s completely isolated with its own equipment, space, and its own air
handler. All the things you need in a laboratory are completely separate. We have a lot of
abilities that we haven’t even touched on using and we have a lot more space than we
are currently occupying. We are open to contracts and to assisting researchers and their product
development. Most of the time the research is done in a
basic lab so these people have figured out how to do it in a test tube or a Petri dish
and it works. It doesn’t necessarily mean when you make it one hundred times larger,
put it in a bag or use materials approved for human use that you can really translate
exactly the same ratios, temperatures or conditions. So, there is that scale up phase that this
facility will have the expertise by having a staff that works on many different kinds
of projects. We will be able to have that expertise to be able to scale up a project
and make it ready for human use. That’s really what our goal is.
The building, a stand-alone structure on the medical center campus, was fitted top to bottom
with state of the art equipment, facilities and staff. Everything here was designed to
make the job of research as efficient as possible. It is equipped with two walk-in cold rooms.
One is designed for reagent storage and another could potentially be used for organ processing,
requiring refrigerated temperatures. We have multi-stage clean up area that you
can transition as you finish processing. You would enter the first stage here and we have
a major clean up sink so you can do debalking and gross decontamination washing of reusable
instrumentation. We also have plumbing and rough in for future expansion if we need to
do terminal sterilization.
One of the facility’s most important features is its eye to the future and adaptability
to research that has yet to be imagined.
There are some other projects that are being worked on that involve particles, novel drugs
and protein materials that we haven’t even thought about how we could work with them.
They are the kind of things that need some manufacturing, clean air and quite a bit of
control to make sure they are done correctly. We have the ability to do most anything from
a manufacturing point of view. We can make nanoparticles , vaccines, anything that requires
a quality system and a clean room. We have a large staff that is experienced and anxious
to do new things. Whatever the product is you have in mind, we call it a cellular therapy
facility, but the product doesn’t have to have cells in it. It could be a drug, protein,
or another molecule or formulation that would be of therapeutic value. It is our goal to
make things that are useful to patients directly.