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Atryn Drug Description
ATryn, Antithrombin
(recombinant) Lyophilized powder for reconstitution
DRUG DESCRIPTION
ATryn for Injection is a nanofiltered, sterile, terminally heat treated, lyophilized
dosage form. Antithrombin (Recombinant), active ingredient of ATryn, is a recombinant
human antithrombin. It is a 432 amino acid glycoprotein with a molecular weight
of approximately 57,215 Daltons. The molecular formula is: C2191H3457N583O656S18.
Antithrombin (Recombinant) is produced by recombinant DNA technology using genetically
engineered goats into which the DNA coding sequence for human antithrombin has
been introduced along with a mammary gland specific DNA sequence, which directs
the expression of the antithrombin into the milk. The goats in which antithrombin
(Recombinant) is produced are USDA certified scrapie-free, and controlled for
specific pathogens.
The amino acid sequence of Antithrombin (Recombinant) is identical to that
of human plasma-derived antithrombin. Antithrombin (Recombinant) and plasma-derived
antithrombin both contain six cysteine residues forming three disulphide bridges
and 3-4 N-linked carbohydrate moieties. The glycosylation profile of Antithrombin
(Recombinant) is different from plasma derived antithrombin, which results in
an increased heparin affinity. When assayed in the presence of excess of heparin
the potency of the recombinant product is not different from that of plasma
derived product.
Each vial of ATryn is tested for potency stated on the product label using
a reference standard calibrated against the World Health Organization international
standard for antithrombin concentrate. In addition to Antithrombin (Recombinant),
each vial of the product contains 100 mg glycine, 79 mg sodium chloride, and
26 mg sodium citrate. When reconstituted with 10 mL Sterile Water for Injection,
the pH is approximately 7.0. Following reconstitution, the solution may be further
diluted into 0.9 % sodium chloride for injection.
ATryn does not contain any preservatives nor is it formulated with human plasma
proteins. Antithrombin (Recombinant) is affinity purified using a heparin immobilized
resin and contains no detectable heparin ( < 0.0002 IU heparin per IU antithrombin)
in the final product.
The purification and drug product manufacturing processes have been validated
to demonstrate its capacity for removal and/or inactivation of viruses4.
Results of removal and/or inactivation for each of the steps are shown in Table
4.
Table 4: Viral Clearance Results (log10 reductions)




Process Step
Pseudorabies
Virus
Xenotropic
Murine
Retrovirus
Human
Adenovirus
Porcine
Parvovirus


Tangential Flow Filtration
≥ 5.1
 
 
 


Affinity Chromatography
1.6
1.2
NA
1.4


Nanofiltration
 
≥ 3.8
≥ 6.3
≥ 3.7


Ion Exchange Chromatography
3.6
1.0
≥ 7.1
NA


Hydrophobic Interaction Chromatography
≥ 5.6
≥ 4.4
≥ 4.8
≥ 5.7


Heat Treatment
2.8
≥ 5.0
≥ 1.8
2.4


Total Reduction
≥ 18.7
≥ 15.4
≥ 20.0
≥ 13.2


NA = Not Applicable since log10
reduction was less than 1.0.



In addition, although the goats are from a closed, USDA certified scrapie-free
herd, the purification process was challenged to remove prions. The manufacturing
steps were shown capable of achieving the following log10 reductions:
2.0 (tangential filtration), 2.2 (affinity column), ≥ 3.3 (ion exchange column), ≥ 3.8
(hydrophobic interaction column).
REFERENCES
(4) Echelard Y, Meade H, Ziomek C. The first biopharmaceutical
from transgenic animals: ATryn. Modern Biopharmaceuticals 2005;995-1016.
Last reviewed on RxList: 3/10/2009




Atryn Drug Description
ATryn, Antithrombin
(recombinant) Lyophilized powder for reconstitution
DRUG DESCRIPTION
ATryn for Injection is a nanofiltered, sterile, terminally heat treated, lyophilized
dosage form. Antithrombin (Recombinant), active ingredient of ATryn, is a recombinant
human antithrombin. It is a 432 amino acid glycoprotein with a molecular weight
of approximately 57,215 Daltons. The molecular formula is: C2191H3457N583O656S18.
Antithrombin (Recombinant) is produced by recombinant DNA technology using genetically
engineered goats into which the DNA coding sequence for human antithrombin has
been introduced along with a mammary gland specific DNA sequence, which directs
the expression of the antithrombin into the milk. The goats in which antithrombin
(Recombinant) is produced are USDA certified scrapie-free, and controlled for
specific pathogens.
The amino acid sequence of Antithrombin (Recombinant) is identical to that
of human plasma-derived antithrombin. Antithrombin (Recombinant) and plasma-derived
antithrombin both contain six cysteine residues forming three disulphide bridges
and 3-4 N-linked carbohydrate moieties. The glycosylation profile of Antithrombin
(Recombinant) is different from plasma derived antithrombin, which results in
an increased heparin affinity. When assayed in the presence of excess of heparin
the potency of the recombinant product is not different from that of plasma
derived product.
Each vial of ATryn is tested for potency stated on the product label using
a reference standard calibrated against the World Health Organization international
standard for antithrombin concentrate. In addition to Antithrombin (Recombinant),
each vial of the product contains 100 mg glycine, 79 mg sodium chloride, and
26 mg sodium citrate. When reconstituted with 10 mL Sterile Water for Injection,
the pH is approximately 7.0. Following reconstitution, the solution may be further
diluted into 0.9 % sodium chloride for injection.
ATryn does not contain any preservatives nor is it formulated with human plasma
proteins. Antithrombin (Recombinant) is affinity purified using a heparin immobilized
resin and contains no detectable heparin ( < 0.0002 IU heparin per IU antithrombin)
in the final product.
The purification and drug product manufacturing processes have been validated
to demonstrate its capacity for removal and/or inactivation of viruses4.
Results of removal and/or inactivation for each of the steps are shown in Table
4.
Table 4: Viral Clearance Results (log10 reductions)




Process Step
Pseudorabies
Virus
Xenotropic
Murine
Retrovirus
Human
Adenovirus
Porcine
Parvovirus


Tangential Flow Filtration
≥ 5.1
 
 
 


Affinity Chromatography
1.6
1.2
NA
1.4


Nanofiltration
 
≥ 3.8
≥ 6.3
≥ 3.7


Ion Exchange Chromatography
3.6
1.0
≥ 7.1
NA


Hydrophobic Interaction Chromatography
≥ 5.6
≥ 4.4
≥ 4.8
≥ 5.7


Heat Treatment
2.8
≥ 5.0
≥ 1.8
2.4


Total Reduction
≥ 18.7
≥ 15.4
≥ 20.0
≥ 13.2


NA = Not Applicable since log10
reduction was less than 1.0.



In addition, although the goats are from a closed, USDA certified scrapie-free
herd, the purification process was challenged to remove prions. The manufacturing
steps were shown capable of achieving the following log10 reductions:
2.0 (tangential filtration), 2.2 (affinity column), ≥ 3.3 (ion exchange column), ≥ 3.8
(hydrophobic interaction column).
REFERENCES
(4) Echelard Y, Meade H, Ziomek C. The first biopharmaceutical
from transgenic animals: ATryn. Modern Biopharmaceuticals 2005;995-1016.
Last reviewed on RxList: 3/10/2009




Atryn Drug Description
ATryn, Antithrombin
(recombinant) Lyophilized powder for reconstitution
DRUG DESCRIPTION
ATryn for Injection is a nanofiltered, sterile, terminally heat treated, lyophilized
dosage form. Antithrombin (Recombinant), active ingredient of ATryn, is a recombinant
human antithrombin. It is a 432 amino acid glycoprotein with a molecular weight
of approximately 57,215 Daltons. The molecular formula is: C2191H3457N583O656S18.
Antithrombin (Recombinant) is produced by recombinant DNA technology using genetically
engineered goats into which the DNA coding sequence for human antithrombin has
been introduced along with a mammary gland specific DNA sequence, which directs
the expression of the antithrombin into the milk. The goats in which antithrombin
(Recombinant) is produced are USDA certified scrapie-free, and controlled for
specific pathogens.
The amino acid sequence of Antithrombin (Recombinant) is identical to that
of human plasma-derived antithrombin. Antithrombin (Recombinant) and plasma-derived
antithrombin both contain six cysteine residues forming three disulphide bridges
and 3-4 N-linked carbohydrate moieties. The glycosylation profile of Antithrombin
(Recombinant) is different from plasma derived antithrombin, which results in
an increased heparin affinity. When assayed in the presence of excess of heparin
the potency of the recombinant product is not different from that of plasma
derived product.
Each vial of ATryn is tested for potency stated on the product label using
a reference standard calibrated against the World Health Organization international
standard for antithrombin concentrate. In addition to Antithrombin (Recombinant),
each vial of the product contains 100 mg glycine, 79 mg sodium chloride, and
26 mg sodium citrate. When reconstituted with 10 mL Sterile Water for Injection,
the pH is approximately 7.0. Following reconstitution, the solution may be further
diluted into 0.9 % sodium chloride for injection.
ATryn does not contain any preservatives nor is it formulated with human plasma
proteins. Antithrombin (Recombinant) is affinity purified using a heparin immobilized
resin and contains no detectable heparin ( < 0.0002 IU heparin per IU antithrombin)
in the final product.
The purification and drug product manufacturing processes have been validated
to demonstrate its capacity for removal and/or inactivation of viruses4.
Results of removal and/or inactivation for each of the steps are shown in Table
4.
Table 4: Viral Clearance Results (log10 reductions)




Process Step
Pseudorabies
Virus
Xenotropic
Murine
Retrovirus
Human
Adenovirus
Porcine
Parvovirus


Tangential Flow Filtration
≥ 5.1
 
 
 


Affinity Chromatography
1.6
1.2
NA
1.4


Nanofiltration
 
≥ 3.8
≥ 6.3
≥ 3.7


Ion Exchange Chromatography
3.6
1.0
≥ 7.1
NA


Hydrophobic Interaction Chromatography
≥ 5.6
≥ 4.4
≥ 4.8
≥ 5.7


Heat Treatment
2.8
≥ 5.0
≥ 1.8
2.4


Total Reduction
≥ 18.7
≥ 15.4
≥ 20.0
≥ 13.2


NA = Not Applicable since log10
reduction was less than 1.0.



In addition, although the goats are from a closed, USDA certified scrapie-free
herd, the purification process was challenged to remove prions. The manufacturing
steps were shown capable of achieving the following log10 reductions:
2.0 (tangential filtration), 2.2 (affinity column), ≥ 3.3 (ion exchange column), ≥ 3.8
(hydrophobic interaction column).
REFERENCES
(4) Echelard Y, Meade H, Ziomek C. The first biopharmaceutical
from transgenic animals: ATryn. Modern Biopharmaceuticals 2005;995-1016.
Last reviewed on RxList: 3/10/2009




Atryn Drug Description
ATryn, Antithrombin
(recombinant) Lyophilized powder for reconstitution
DRUG DESCRIPTION
ATryn for Injection is a nanofiltered, sterile, terminally heat treated, lyophilized
dosage form. Antithrombin (Recombinant), active ingredient of ATryn, is a recombinant
human antithrombin. It is a 432 amino acid glycoprotein with a molecular weight
of approximately 57,215 Daltons. The molecular formula is: C2191H3457N583O656S18.
Antithrombin (Recombinant) is produced by recombinant DNA technology using genetically
engineered goats into which the DNA coding sequence for human antithrombin has
been introduced along with a mammary gland specific DNA sequence, which directs
the expression of the antithrombin into the milk. The goats in which antithrombin
(Recombinant) is produced are USDA certified scrapie-free, and controlled for
specific pathogens.
The amino acid sequence of Antithrombin (Recombinant) is identical to that
of human plasma-derived antithrombin. Antithrombin (Recombinant) and plasma-derived
antithrombin both contain six cysteine residues forming three disulphide bridges
and 3-4 N-linked carbohydrate moieties. The glycosylation profile of Antithrombin
(Recombinant) is different from plasma derived antithrombin, which results in
an increased heparin affinity. When assayed in the presence of excess of heparin
the potency of the recombinant product is not different from that of plasma
derived product.
Each vial of ATryn is tested for potency stated on the product label using
a reference standard calibrated against the World Health Organization international
standard for antithrombin concentrate. In addition to Antithrombin (Recombinant),
each vial of the product contains 100 mg glycine, 79 mg sodium chloride, and
26 mg sodium citrate. When reconstituted with 10 mL Sterile Water for Injection,
the pH is approximately 7.0. Following reconstitution, the solution may be further
diluted into 0.9 % sodium chloride for injection.
ATryn does not contain any preservatives nor is it formulated with human plasma
proteins. Antithrombin (Recombinant) is affinity purified using a heparin immobilized
resin and contains no detectable heparin ( < 0.0002 IU heparin per IU antithrombin)
in the final product.
The purification and drug product manufacturing processes have been validated
to demonstrate its capacity for removal and/or inactivation of viruses4.
Results of removal and/or inactivation for each of the steps are shown in Table
4.
Table 4: Viral Clearance Results (log10 reductions)




Process Step
Pseudorabies
Virus
Xenotropic
Murine
Retrovirus
Human
Adenovirus
Porcine
Parvovirus


Tangential Flow Filtration
≥ 5.1
 
 
 


Affinity Chromatography
1.6
1.2
NA
1.4


Nanofiltration
 
≥ 3.8
≥ 6.3
≥ 3.7


Ion Exchange Chromatography
3.6
1.0
≥ 7.1
NA


Hydrophobic Interaction Chromatography
≥ 5.6
≥ 4.4
≥ 4.8
≥ 5.7


Heat Treatment
2.8
≥ 5.0
≥ 1.8
2.4


Total Reduction
≥ 18.7
≥ 15.4
≥ 20.0
≥ 13.2


NA = Not Applicable since log10
reduction was less than 1.0.



In addition, although the goats are from a closed, USDA certified scrapie-free
herd, the purification process was challenged to remove prions. The manufacturing
steps were shown capable of achieving the following log10 reductions:
2.0 (tangential filtration), 2.2 (affinity column), ≥ 3.3 (ion exchange column), ≥ 3.8
(hydrophobic interaction column).
REFERENCES
(4) Echelard Y, Meade H, Ziomek C. The first biopharmaceutical
from transgenic animals: ATryn. Modern Biopharmaceuticals 2005;995-1016.
Last reviewed on RxList: 3/10/2009




Atryn Drug Description
ATryn, Antithrombin
(recombinant) Lyophilized powder for reconstitution
DRUG DESCRIPTION
ATryn for Injection is a nanofiltered, sterile, terminally heat treated, lyophilized
dosage form. Antithrombin (Recombinant), active ingredient of ATryn, is a recombinant
human antithrombin. It is a 432 amino acid glycoprotein with a molecular weight
of approximately 57,215 Daltons. The molecular formula is: C2191H3457N583O656S18.
Antithrombin (Recombinant) is produced by recombinant DNA technology using genetically
engineered goats into which the DNA coding sequence for human antithrombin has
been introduced along with a mammary gland specific DNA sequence, which directs
the expression of the antithrombin into the milk. The goats in which antithrombin
(Recombinant) is produced are USDA certified scrapie-free, and controlled for
specific pathogens.
The amino acid sequence of Antithrombin (Recombinant) is identical to that
of human plasma-derived antithrombin. Antithrombin (Recombinant) and plasma-derived
antithrombin both contain six cysteine residues forming three disulphide bridges
and 3-4 N-linked carbohydrate moieties. The glycosylation profile of Antithrombin
(Recombinant) is different from plasma derived antithrombin, which results in
an increased heparin affinity. When assayed in the presence of excess of heparin
the potency of the recombinant product is not different from that of plasma
derived product.
Each vial of ATryn is tested for potency stated on the product label using
a reference standard calibrated against the World Health Organization international
standard for antithrombin concentrate. In addition to Antithrombin (Recombinant),
each vial of the product contains 100 mg glycine, 79 mg sodium chloride, and
26 mg sodium citrate. When reconstituted with 10 mL Sterile Water for Injection,
the pH is approximately 7.0. Following reconstitution, the solution may be further
diluted into 0.9 % sodium chloride for injection.
ATryn does not contain any preservatives nor is it formulated with human plasma
proteins. Antithrombin (Recombinant) is affinity purified using a heparin immobilized
resin and contains no detectable heparin ( < 0.0002 IU heparin per IU antithrombin)
in the final product.
The purification and drug product manufacturing processes have been validated
to demonstrate its capacity for removal and/or inactivation of viruses4.
Results of removal and/or inactivation for each of the steps are shown in Table
4.
Table 4: Viral Clearance Results (log10 reductions)




Process Step
Pseudorabies
Virus
Xenotropic
Murine
Retrovirus
Human
Adenovirus
Porcine
Parvovirus


Tangential Flow Filtration
≥ 5.1
 
 
 


Affinity Chromatography
1.6
1.2
NA
1.4


Nanofiltration
 
≥ 3.8
≥ 6.3
≥ 3.7


Ion Exchange Chromatography
3.6
1.0
≥ 7.1
NA


Hydrophobic Interaction Chromatography
≥ 5.6
≥ 4.4
≥ 4.8
≥ 5.7


Heat Treatment
2.8
≥ 5.0
≥ 1.8
2.4


Total Reduction
≥ 18.7
≥ 15.4
≥ 20.0
≥ 13.2


NA = Not Applicable since log10
reduction was less than 1.0.



In addition, although the goats are from a closed, USDA certified scrapie-free
herd, the purification process was challenged to remove prions. The manufacturing
steps were shown capable of achieving the following log10 reductions:
2.0 (tangential filtration), 2.2 (affinity column), ≥ 3.3 (ion exchange column), ≥ 3.8
(hydrophobic interaction column).
REFERENCES
(4) Echelard Y, Meade H, Ziomek C. The first biopharmaceutical
from transgenic animals: ATryn. Modern Biopharmaceuticals 2005;995-1016.
Last reviewed on RxList: 3/10/2009





Other reviews about Atryn on wordpress

Anticlotting Drug From Genetically Engineered Goats Is Safe Says FDA Panel
  by enartion
An expert panel that advises the US Food and Drug Adminstration (FDA) voted that the anti-clotting drug ATryn, which is made from the milk of genetically engineered goats, […]


FDA Advisory Committee Recommends GTC Biotherapeutics' ATryn (antithrombin [Recombinant])
  by enartion
GTC Biotherapeutics ("GTC", NASDAQ: GTCB) and OVATION Pharmaceuticals, Inc. announced that the Blood Products Advisory Committee of the U.S. Food and Drug Administration (FDA) voted that ATryn is […]


Are Goats A Drug?
  by The Erie Wire
  FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA FDA News FOR IMMEDIATE RELEASE February 6, 2009 Media Inquiries:  Siobhan DeLancey, 301-796-4668 Consumer Inquiries:  888-INFO-FDA FDA Approves Orphan Drug ATryn to Treat Rare Clotting Disorder The U.S. Food […]


Drug Goat Cartel Hits The Market
  by The Erie Wire
Drug from genetically engineered goat approved without public hearing, violating consumers’ rights Posted on February 6, 2009 by Heather & Disseminated by The Erie Wire  Center for Food Safety Calls FDA Action “An […]


Blood Clotting Drug, ATryn, From Genetically Engineered Goats Approved By FDA
  by enartion
The FDA (Food and Drug Administration) has approved the first ever biological product produced by a genetically engineered animal - a goat. ATryn is an anticoagulant, used for […]


ADDING MULTIMEDIA ATryn(R) (Antithrombin [Recombinant]) Approved By The FDA
  by enartion
GTC Biotherapeutics ("GTC", NASDAQ: GTCB) and OVATION Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) approved ATryn® (Antithrombin [Recombinant]) for the prevention of peri-operative and […]


Trends in 2009: Genetically Engineered Animal Approvals
  by Jeremy G
The past few weeks have seen at least three conspicuous developments towards a functional regulatory regime that will lead to increasing numbers of FDA approvals for Genetically Engineered (GE) animals: The FDA […]


FDA Approves Orphan Drug ATryn To Treat Rare Clotting Disorder
  by enartion
The U.S. Food and Drug Administration issued its first approval for a biological product produced by genetically engineered (GE) animals. The approval is for ATryn, an anticoagulant used […]


FDA Approves Orphan Drug ATryn To Treat Rare Clotting Disorder
  by healtherm2
The U.S. Food and Drug Administration issued its first approval for a biological product produced by genetically engineered (GE) animals. The approval is for ATryn, an anticoagulant […]


GTC Biotherapeutics goes for a Regulatory Double Combo Shot
  by Jeremy G
GTC Biotherapeutics, which recently saw ATryn approved, announced a collaboration agreement with AgResearch Limited, a New Zealand Crown Research Institute.  AgResearch will develop genetically modified animals capable of producing the building […]



Other reviews about Atryn on web:

Official site from GTC Biotherapeutics. Includes prescribing information and press releases. ATryn®, recombinant human antithrombin


ATryn is the brand name of the anticoagulant antithrombin manufactured by the Massachusetts-based U.S. company GTC Biotherapeutics. It is made from the milk of goats that have been ... ATryn - Wikipedia, the free encyclopedia


ATryn (antithrombin [recombinant]) is used for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. Includes ATryn ... ATryn Information from Drugs.com


ATryn is a recombinant antithrombin indicated for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. It is not ... ATryn is a recombinant antithrombin indicated for the *prevention ...


ATryn (antithrombin alfa) is a new drug in development for patients with antithrombin deficiency. ATryn information includes news, clinical trial results and side effects. FDA Advisory Committee Recommends GTC Biotherapeutics' ATryn ...


Learn about the prescription medication Atryn (Recombinant Lyophilized Powder), drug uses, dosage, side effects, drug interactions, warnings, reviews and patient labeling. Atryn (Recombinant Lyophilized Powder) Drug Information: Uses ...


ATryn® (Antithrombin [Recombinant]) Approved by the FDA . Only recombinant option for patients with hereditary antithrombin deficiency, a rare and potentially life-threatening ... ATryn® (Antithrombin [Recombinant]) Approved by the FDA


May 6, 2009 – Lundbeck Inc., a wholly owned subsidiary of H. Lundbeck A/S in Denmark (LUN: Copenhagen Stock Exchange), announced today that ATryn® (Antithrombin [Recombinant ... ATryn Available for Patients with Hereditary Antithrombin ...


First drug from transgenic goats nears approval ... Editor's note: We're posting this story from our September 2006 issue because of recent FDA action on ATryn. ATryn, on Old MacDonald's Pharm: Scientific American


Bryn Athyn College is a small, private Christian liberal arts college located 20 miles northeast of Philadelphia in the borough of Bryn Athyn, Pennsylvania, a National Historic ... Bryn Athyn College - Wikipedia, the free encyclopedia





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