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These excerpts taken from the ASTM 10-K filed Aug 29, 2008. Manufacturing
Cell
Manufacturing
Our TRC-based cell products will be regulated in the U.S., EU
and other markets as somatic cell
therapies/biologics/pharmaceuticals. With this classification,
commercial manufacturing of TRC-based products will need to
occur in registered/licensed facilities in compliance with Good
Tissue Practice (GTP, U.S., FDA), Good Manufacturing
Practice (GMP) for biologics (cellular products) or drugs, and
the EU Tissue Procurement and GMP Directives.
In May 2006, we received a human pharmaceuticals manufacturing
license from a regional regulatory authority in Germany for the
production of TRC-based products at the Fraunhofer Institute for
Interfacial Engineering and Biotechnology (Fraunhofer). This
license allows us to produce our TRC-based products in
compliance with EU regulations. The Fraunhofer facility and
staff are under contract for the manufacturing of
TRC-based
products for both clinical trials and commercial activity under
the license.
In the U.S. we have established and operate a pilot cell
manufacturing facility in our Ann Arbor location to support the
current U.S. clinical trials. We intend to establish and
operate our own larger commercial-scale cell manufacturing
facilities for the EU and U.S. markets in the future to
accommodate potential market growth.
Cell
Manufacturing Platform Components
We have established relationships with manufacturers that are
FDA registered as suppliers of medical products to manufacture
various components of our patented cell manufacturing system.
In March 2003, we signed a master supply agreement with Astro
Instrumentation, L.L.C., to manufacture our final assemblies,
component parts, subassemblies and associated spare parts, used
in the instrumentation platform of our cell manufacturing
system. This agreement automatically renews every 12 months
unless canceled. We retain all proprietary rights to our
intellectual property that is utilized by Astro pursuant to this
agreement.
In February 2004, we entered into a five-year continuing
agreement with Moll Industries as our supplier of the cell
culture cassettes used in the production of TRC-based products.
Under this agreement, Moll performs the manufacturing and
assembly of the cassettes while we retain all rights to our
intellectual property that is utilized by Moll pursuant to this
agreement.
There can be no assurance that we will be able to continue our
present arrangements with our suppliers, supplement existing
relationships or establish new relationships or that we will be
able to identify and obtain the ancillary materials that are
necessary to develop our product candidates in the future. Our
dependence upon third
Table of Contents
parties for the supply and manufacture of such items could
adversely affect our ability to develop and deliver commercially
feasible products on a timely and competitive basis. See
“Risk Factors.”
Manufacturing Cell Manufacturing Our TRC-based cell products will be regulated in the U.S., EU and other markets as somatic cell therapies/biologics/pharmaceuticals. With this classification, commercial manufacturing of TRC-based products will need to occur in registered/licensed facilities in compliance with Good Tissue Practice (GTP, U.S., FDA), Good Manufacturing Practice (GMP) for biologics (cellular products) or drugs, and the EU Tissue Procurement and GMP Directives. In May 2006, we received a human pharmaceuticals manufacturing license from a regional regulatory authority in Germany for the production of TRC-based products at the Fraunhofer Institute for Interfacial Engineering and Biotechnology (Fraunhofer). This license allows us to produce our TRC-based products in compliance with EU regulations. The Fraunhofer facility and staff are under contract for the manufacturing of TRC-based products for both clinical trials and commercial activity under the license. In the U.S. we have established and operate a pilot cell manufacturing facility in our Ann Arbor location to support the current U.S. clinical trials. We intend to establish and operate our own larger commercial-scale cell manufacturing facilities for the EU and U.S. markets in the future to accommodate potential market growth. Cell Manufacturing Platform Components We have established relationships with manufacturers that are FDA registered as suppliers of medical products to manufacture various components of our patented cell manufacturing system. In March 2003, we signed a master supply agreement with Astro Instrumentation, L.L.C., to manufacture our final assemblies, component parts, subassemblies and associated spare parts, used in the instrumentation platform of our cell manufacturing system. This agreement automatically renews every 12 months unless canceled. We retain all proprietary rights to our intellectual property that is utilized by Astro pursuant to this agreement. In February 2004, we entered into a five-year continuing agreement with Moll Industries as our supplier of the cell culture cassettes used in the production of TRC-based products. Under this agreement, Moll performs the manufacturing and assembly of the cassettes while we retain all rights to our intellectual property that is utilized by Moll pursuant to this agreement. There can be no assurance that we will be able to continue our present arrangements with our suppliers, supplement existing relationships or establish new relationships or that we will be able to identify and obtain the ancillary materials that are necessary to develop our product candidates in the future. Our dependence upon third
Table of Contentsparties for the supply and manufacture of such items could adversely affect our ability to develop and deliver commercially feasible products on a timely and competitive basis. See “Risk Factors.” This excerpt taken from the ASTM 10-K filed Sep 13, 2007. Manufacturing
Cell
Manufacturing
Our TRC-based cell products will be regulated in the U.S., EU
and other markets as biologics/pharmaceuticals. With this
classification, commercial manufacturing of TRC-based products
will need to occur in registered/licensed facilities in
compliance with Good Tissue Practice (GTP, U.S. FDA), Good
Manufacturing Practice (GMP) for biologics (cellular products)
or drugs, and the EU Tissue Procurement and GMP Directives.
In May 2006, we received a human pharmaceuticals manufacturing
license from a regional regulatory authority in Germany for the
production of TRC-based products at the Fraunhofer Institute for
Interfacial Engineering and Biotechnology (Fraunhofer). This
license allows us to produce our TRC-based products for clinical
trials in compliance with EU regulations. The Fraunhofer
facility and staff are under contract for the manufacturing of
TRC-based products for both clinical trials and commercial
activity under the license.
In the U.S. we have established and operate a pilot cell
manufacturing facility in our Ann Arbor location to support the
current U.S. clinical trials. We intend to establish and
operate our own larger commercial-scale cell manufacturing
facilities for the EU and U.S. markets in the future to
accommodate potential market growth.
Table of Contents
Cell
Manufacturing Platform Components
We have established relationships with manufacturers that are
FDA registered as suppliers of medical products to manufacture
various components of our patented cell manufacturing system.
In March 2003, we signed a master supply agreement with Astro
Instrumentation, L.L.C., to manufacture our final assemblies,
component parts, subassemblies and associated spare parts, used
in the instrumentation platform of our cell manufacturing
system. This agreement automatically renews every 12 months
unless canceled. We retain all proprietary rights to our
intellectual property that is utilized by Astro pursuant to this
agreement.
In February 2004, we entered into a five-year continuing
agreement with Moll Industries as our supplier of the cell
culture cassettes used in the production of TRC-based products.
Under this agreement, Moll performs the manufacturing and
assembly of the cassettes while we retain all rights to our
intellectual property that is utilized by Moll pursuant to this
agreement.
There can be no assurance that we will be able to continue our
present arrangements with our suppliers, supplement existing
relationships or establish new relationships or that we will be
able to identify and obtain the ancillary materials that are
necessary to develop our product candidates in the future. Our
dependence upon third parties for the supply and manufacture of
such items could adversely affect our ability to develop and
deliver commercially feasible products on a timely and
competitive basis. See “Risk Factors.”
This excerpt taken from the ASTM 10-K filed Sep 13, 2006. Manufacturing
Cell
Manufacturing
Aastrom’s TRC cell products will be regulated in the U.S.,
EU and other markets as biologics/pharmaceuticals. With this
classification, commercial manufacturing of TRCs will need to
occur in registered/licensed facilities in compliance with Good
Tissue Practice (GTP, U.S. FDA), Good Manufacturing
Practice (GMP) for biologics (cellular products) or drugs, and
the EU Tissue Procurement and GMP Directives.
In May 2006, we received a human pharmaceuticals manufacturing
license from a regional regulatory authority in Germany for the
production of TRCs at the Fraunhofer Institute for Interfacial
Engineering and Biotechnology (Fraunhofer). This license allows
us to produce our TRC-based products for clinical trials in
compliance with EU regulations. The Fraunhofer facility and
staff are under contract for the manufacturing of TRC products
for both clinical trials and commercial activity under the
license.
In the U.S., we have established and operate a pilot cell
manufacturing facility in our Ann Arbor location, to support the
current U.S. clinical trials. We intend to establish and
operate our own larger commercial-scale cell manufacturing
facilities for the EU and U.S. markets in the future to
accommodate potential market growth.
Cell
Manufacturing Platform Components
We have established relationships with manufacturers that are
FDA registered as suppliers of medical products to manufacture
various components of our patented cell manufacturing system.
In March 2003, we signed a three-year master supply agreement
with Astro Instrumentation, L.L.C., to manufacture our final
assemblies, component parts, subassemblies and associated spare
parts, used in the instrumentation platform of our cell
manufacturing system. This agreement includes an annual
provision for automatic 12 month extensions. We retain all
proprietary rights to our intellectual property that is utilized
by Astro pursuant to this agreement.
In February 2004, we entered into a five-year agreement
continuing with Moll Industries as our supplier of the cell
culture cassettes used in the production of TRCs. Under this
agreement, Moll will perform the manufacturing and assembly of
the cassettes while we retain all rights to our intellectual
property that is utilized by Moll pursuant to this agreement.
There can be no assurance that we will be able to continue our
present arrangements with our suppliers, supplement existing
relationships or establish new relationships or that we will be
able to identify and obtain the ancillary materials that are
necessary to develop our product candidates in the future. Our
dependence upon third parties for the supply and manufacture of
such items could adversely affect our ability to develop and
deliver commercially feasible products on a timely and
competitive basis. See “Risk Factors.”
Table of Contents
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