Antihemophilic Factor (Human), Method M, Monoclonal Purified - Monarc-M; Factor VIII:von Wille-brand’s factor complex; Factor VIII:C
Status: approved; marketed
Organizations involved:
American National Red Cross (ARC) – USA mark.; Former
Baxter Hyland Immuno – Manuf.; R&D; Tech.; World mark.
Genetics Institute, Inc. – Tech.; Former
Wyeth – Tech.; Parent
New York Blood Center, Inc. – Tech.
Cross ref: See the entry (#722) for Antihemophilic Factor (Human), Method M, Monoclonal Purified or Hemofil M from Baxter Hyland Immuno, which is substantially identical to this product. See also the entry for Factor VIII Products (#715).
Description: Antihemophilic Factor (Human), Method M, Monoclonal Purified or Monarc-M is a lyophilized (freeze-dried) formulation of a Factor VIII:C (Factor VIII:von Willebrand’s factor complex; FVIII:vWF) manufactured from pooled Plasma with processing including immunoaffinity chromatography (Method M using matrix-bound murine Factor VIII monoclonal antibodies), ion exchange chromatography, and viral inactivation using the solvent detergent process which substantially reduces titers of enveloped viruses. Monarc-M is a highly purified Factor VIII:C product. It has an activity range of 2 to 15 AHF International Units/mg of total protein; with a specific activity of approximately 2,000 International Units/mg of protein before addition of human albumin as a stabilizer. The protein in greatest concentration in Monarc-M is Albumin (Human).
Until March 2005, Monarc-M was manufactured for the American Red Cross (ARC) by Baxter Hyland Immuno. Baxter has now assumed the plasma processing and plasma derivatives business of ARC. Monarc-M is the same as Hemofil M manufactured and marketed by Baxter Hyland Immuno, except that the source Plasma and Albumin (Human) used as a stabilizer are obtained from ARC volunteer plasma donors, while Hemofil M is derived from Plasma and Albumin (Human) obtained from Plasma primarily from paid plasmapheresis donors.
Each bottle of Monarc-M is labeled with its Factor VIII activity content expressed in International Units (IU) per bottle, referenced to the WHO International Standard. It has an activity range of 2 to 15 International Units/mg of total protein; with a specific activity of approximately 2,000 International Units/mg of protein before addition of Albumin (Human) as a stabilizer. After reconstitution with the appropriate volume of diluent, the product contains approximately 12.5 mg/mL Albumin (Human), 1.5 mg/mL polyethylene glycol (3350), 0.055 M histidine, and 0.030 M glycine as stabilizing agents. Hemofil M also contains, per AHF International Unit, not more than 0.1 ng murine (mouse) protein (from immunoaffinity purification), and residues from solvent detergent viral inactivation – 18 ng organic solvent (tri-n-butyl phosphate) and 50 ng detergent (octoxynol; Triton X-100).
Nomenclature: Factor VIII:vWF, Mab purif./ARC [BIO]; Monarc-M [TR]; Antihemophilic Factor (Human), Method M, Monoclonal Purified [FDA]; Antihemophilic Factor [USAN]; Antihemophilic Factor, Human [former USAN]; Antihemophilic Factor USP [USP]; Blood-coagulation factor VIII, complex [CAS]; Factor VIII:C [SY]
Companies.: Monarc-M was developed and is manufactured by Baxter Hyland Immuno (Glendale, CA), CBER/FDA lic. no. 0140, a subsidiary of Baxter Healthcare Corp., for the American National Red Cross (American Red Cross; ARC). Until April 2005, Monarc-M was marketed and distributed in the U.S. by ARC. In April 2005, Baxter acquired the plasma derivatives business of ARC.
FDA class: Biologic PLA
CBER class: Blood And Blood Derivatives
Approvals: Date = 19960311; first approval, PLA, for monoclonal purified product (Hemofil M) manufactured by Baxter Healthcare Corp. (identical to Monarc-M)
Indications: = see the Hemofil M entry (#722)
Status: Various sources indicate that Monarc-M is still marketed and available, although Baxter has assumed the product and markets is own brand (see entry below). Baxter apparently has retained the Monarc-M trade name for monoclonal antibody-purified Factor VIII:vWF manufactured from plasma obtained from the American Red Cross.
Tech. transfer: See the entry (#722) for Antihemophilic Factor (Human), Method M, Monoclonal Purified or Hemofil M from Baxter Hyland Immuno.
Market: The 2007 Average Wholesale Price (AWP) is $1.02/IU (unchanged from 2004) (Red Book, 2007).
Medicare reimbursement is set at $0.90/IU for inpatient and home care, and $0.51/IU for outpatient care. Estimated Acquisition Costs (for hospitals, treatment centers) is $0.40-$0.54/IU [data from NHF].
In its March 22, 2006 price list, FFF Enterprises, a major biologics distributor, reported $0.46/IU for all sizes ($0.51 in 2005; $0.44/IU in 2004).
Companies involvement:
Full monograph
721 Factor VIII:vWF, Mab purif./ARC
Nomenclature:
Factor VIII:von Willebrand's Factor complex []
Factor VIII:C, Mab purif./ARC [BIO]
Monarc-M [TR]
Antihemophilic Factor (Human), Method M, Monoclonal Purified [FDA]
Antihemophilic Factor [USAN]
Antihemophilic Factor, Human [former USAN]
Blood-coagulation factor VIII, complex [CAS]
Blood-coagulation factor VIII, complex [CAS]
AHF [SY]
Factor VIII:C [SY]
FDA Class: Biologic PLA
Year of approval (FDA) = 1996
Date of 1st FDA approval = 19960311
(in format YYYYMMDD)
Index Terms:
antihemophilic factors
biopharmaceutical products
blood products
human materials used<!-- humansource -->
murine (mouse) materials used
ATCC HB 10494
gentamicin (gentamycin)
murine feeder cells
murine myeloma cells
oxidized follitropin alfa
Albumin (Human)
exempt from CBER lot release requirements
Factor VIII monoclonal antibodies
glycine
histidine
immunoaffinity chromatography
lyophilized (freeze-dried)
Method M
monoclonal antibody, murine Factor VIII
murine monoclonal antibody, CD3
murine monoclonal antibody, Factor VIII
murine proteins
octoxynol (Triton X-100)
Plasma (Human)
PYinsl yeast cells
Sepharose
tri-n-butyl phosphate (TNBP)
viral inactivation, solvent detergent
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
EU200 Currently Approved in EU
UM001 Marketed Product in US
US200 Currently Approved in US
EM001 Marketed Product in EU
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