Current Progress in the Production of Recombinant Human Fibrinogen in the Milk of Transgenic Animals

Butler, S. P.; Cott, Kevin Van; Subrumanian, A; Gwazduaskas, F C; Velander, William H.

doi:10.1055/s-0038-1657584

Cited by 27 publications

(8 citation statements)

References 12 publications

(18 reference statements)

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“…[32][33][34][35] However, the small amount of rFI produced in mice limited detailed molecular and material characterization where in vivo studies such as on fibrin tissue adhesion were not possible. Here we provide the first report on the biosynthesis and material characterization of rFI made in the milk of cloned, transgenic dairy cows.…”

Section: Page 2 Of 31 Biomacromoleculesmentioning

confidence: 99%

Technologies for Hemostasis and Stabilization of the Acute Traumatic Wound

Carlson¹,

Velander²,

Larsen³

et al. 2012

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Public reporting burden for this collection of information is estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing this collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to Department of Defense, Washington Headquarters Services, Directorate for Information Operations and Reports (0704-0188), 1215 Jefferson Davis Highway, Suite 1204, Arlington, VA 22202-4302. Respondents should be aware that notwithstanding any other provision of law, no person shall be subject to any penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. PLEASE DO NOT RETURN YOUR FORM TO THE ABOVE ADDRESS. REPORT DATE PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) 8. PERFORMING ORGANIZATION REPORT NUMBERUniversity of Nebraska Omaha, NE 68198-6810 SPONSORING / MONITORING AGENCY NAME(S) AND ADDRESS(ES) 10. SPONSOR/MONITOR'S ACRONYM(S) U.S. Army Medical Research and Materiel Command Fort Detrick, Maryland 21702-5012 SPONSOR/MONITOR'S REPORT NUMBER(S) DISTRIBUTION / AVAILABILITY STATEMENTApproved for Public Release; Distribution Unlimited SUPPLEMENTARY NOTES ABSTRACTThe purpose of this research is to advance hemostasis technology, and to develop effective hemostatic devices for two difficult types of hemorrhage: (1) traumatic noncompressible (also known as truncal) hemorrhage; and (2) traumatic hemorrhage in the cold coagulopathic subject. The scope of this research will include both military and civilian trauma victims, particularly those suffering from hemorrhagic truncal injury and/or coagulopathic hemorrhage, from both penetrating and blunt mechanism.During the first year of this project, we successfully generated stocks of two vitally important clotting factors (fibrinogen and Factor XIII), which we will need for the development and manufacture of our hemostatic devices. In addition, we developed prototypical methods to deliver foaming technology for the treatment of noncompressible hemorrhage, and created iterations of resorbable synthetic gauze for use as hemostatic bandages. We also generated preliminary preclinical data using both the noncompressible and the cold coagulopathic hemorrhage models (both in swine), and are positioned to perform extensive testing during the next year of the project. The subject of this research project is the treatment of hemorrhagic in two difficult clinical scenarios: (1) traumatic noncompressible (also known as truncal) hemorrhage; and (2) traumatic hemorrhage in the cold coagulopathic subject. The purpose of this research is to advance the technology of hemostasis, and to use preclinical large animal models to test hemostatic technologies on the two difficult types of hemorrhage named above. The scope of this research will include both military and civilian trauma victims, par...

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Section: Page 2 Of 31 Biomacromoleculesmentioning

confidence: 99%

Technologies for Hemostasis and Stabilization of the Acute Traumatic Wound

Carlson¹,

Velander²,

Larsen³

et al. 2012

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“…Transgenic fibrinogen can be expressed in mice at 200 μg/ml [73] and in larger animals (goats or cows) to improve productivity [26]. Fully assembled rh‐fibrinogen can be secreted at 0·1–5 g/l levels in the mammary gland, but some unassembled rh‐fibrinogen chains are also secreted [74]. Rh‐fibrinogen from transgenic goats has been granted Orphan Drug Status by the US FDA for substitutive IV therapy and could also be considered for use as fibrin glue and gauze dressing component.…”

Section: Coagulation Factorsmentioning

confidence: 99%

Recombinant plasma proteins

Burnouf

2010

Vox Sanguinis

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For almost 50 years, the fractionation of human plasma has been the sole possible source of a wide range of therapeutic proteins--such as coagulation factors, anticoagulants, immunoglobulins, and albumin--essential to the treatment of serious congenital or acquired bleeding or immunological diseases. In the last 20 years, the application of recombinant technologies to mammalian cell cultures has made possible--although with some limitations in productivity, costs, and immunogenic risks--to produce and commercialize complex plasma glycoproteins for human therapeutic applications and has opened the way to the development of new molecular entities. Today, the advanced exploration of alternative cell lines and enhanced cell culture systems, as well as the development of alternative expression technologies, such as transgenic animals, is opening a new era in the production of the full range of recombinant plasma protein therapeutics. In this review, we examine the achievements and ongoing challenges of the recombinant DNA technology as a platform for the production of plasma proteins and the advantages and limitations of such products compared to fractionated plasma proteins.

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“…In particular, there is a possibility that more than one copy of the gene is transferred, the inserted genes may not function as planned or the animal's natural genes may be disrupted. Unpredictable mutations in the subsequent generations may occur as well (Butler et al, 1997). Concerning the proposition that a genetically engineered animal may receive greater attention and better veterinary care because of its value to the producer, these benefits may be offset by limitations on the natural behavior of the animal, restricted movement and indoor confinement.…”

Section: The Ethical Implications Of Animal Genetic Engineeringmentioning

confidence: 99%