Blood Plasma Products

Our products are made from blood plasma donated in Japan. As part of our work process, we perform virus testing on plasma, as well as the inactivation and removal of viruses during the manufacturing process. We also perform virus tests on final products to ensure the safety of all our blood plasma products. Under Japanese regulations, plasma-derived products cannot be exported.

History

The Japanese blood donation system began in 1964. The following year our intramuscular immunoglobulin was approved for use, followed by the approval of our albumin in 1966.

  • 1979: Launched Confact8 (Coagulation Factor VIII/von Willebrand Factor Complex)
  • 1980: Launched Venilon-I (Sulfonated Intravenous Immunoglobulin)
  • 1985: Launched ConfactF (Coagulation Factor VIII/von Willebrand Factor Complex)
  • 1991: Launched BOLHEAL (Fibrin Sealant)
  • 1992: Launched NovactM (Coagulation Factor IX Preparation)
  • 2001: Launched AnactC (Activated Protein C)
  • 2014: Launched Byclot (Coagulation Factor VIIa Containing Factor X)

Byclot

(Human Coagulation Factor VIIa containing Factor X)

Byclot®
Indications :

Control of bleeding episodes in patients with blood coagulation factor VIII or factor IX deficiency with inhibitors.

Storage :

10°C or below

Shelf life :

3 years

Virus inactivation/reduction :
  • Plasma material PCR (NAT) testing for HIV, HBV, HCV, and parvovirus B19.
  • Anion exchange chromatography
  • Affinity chromatography
  • Solvent/detergent treatment
  • Nanofiltration
  • Dry heat treatment (65°C, 96h)
  • Final product PCR (NAT) testing for HIV, HBV, HCV, and parvovirus B19.

NovactM

(Human Coagulation Factor IX)

Novact®M
Indications :

Control of bleeding episodes in patients with blood coagulation factor IX deficiency.

Storage :

30°C or below

Shelf life :

2 years

Virus inactivation/reduction :
  • Plasma material PCR (NAT) testing for HIV, HBV, HCV, and parvovirus B19.
  • Anion exchange chromatography
  • Affinity chromatography
  • Nanofiltration
  • Dry heat treatment (65°C, 96h)
  • Final product PCR (NAT) testing for HIV, HBV, HCV, and parvovirus B19.

Confact F I.V. Injection 250 units, 500 units, 1000 units

(Human Coagulation Factor VIII/von Willebrand Factor Complex)

Confact®F
Indications :
  1. Control of bleeding episodes in patients with blood coagulation factor VIII deficiency.
  2. Control of bleeding episodes in patients with von Willebrand disease.
Storage :

10°C or below

Shelf life :

3 years

Virus inactivation/reduction :
  • Plasma material PCR (NAT) testing for HIV, HBV, HCV, and parvovirus B19.
  • Ion exchange chromatography
  • Nanofiltratin
  • Dry heat treatment (65°C, 96h)
  • Final product PCR (NAT) testing for HIV, HBV, HCV, and parvovirus B19.

AnactC

(Human Activated Protein C)

Anact®C
Indications :

The following diseases caused by congenital protein C deficiency

  1. Deep vein thrombosis, acute pulmonary thromboembolism
  2. Purpuric purpura
Storage :

10°C or below

Shelf life :

3 years

Virus inactivation/reduction :
  • Plasma material PCR (NAT) testing for HIV, HBV, HCV, and parvovirus B19.
  • Affinity chromatography
  • Nanofiltratin
  • Dry heat treatment (65°C, 96h)
  • Final product PCR (NAT) testing for HIV, HBV, HCV, and parvovirus B19.

BOLHEAL

(Fibrin Sealant (Human))

BOLHEAL®
Indications :

Tissue adhesion and closure

Storage :

10°C or below

Shelf life :

2 years

Virus inactivation/reduction :
  • Plasma material PCR (NAT) testing for HIV, HBV, HCV, and parvovirus B19.
  • Nanofiltratin
  • Dry heat treatment (Thrombin: 65°C/96h, Fibrinogen: 65°C/144h)
  • Final product PCR (NAT) testing for HIV, HBV, HCV, and parvovirus B19.

Kenketsu Venilon-I

(Intravenous Immunoglobulin (Human))

Kenketsu Venilon®-I
Indications :
  1. Hypogammaglobulinemia or agammaglobulinemia
  2. Combined use with antibiotics in severe infections
  3. Idiopathic thrombocytopenic purpura (when other medications are ineffective and there is a remarkable bleeding tendency and temporary hemostasis management such as surgical treatment or delivery is required)
  4. Acute Kawasaki disease (in severe cases with a risk of coronary artery dysfunction)
  5. Guillain-Barre syndrome (in severe cases causing difficulties walking in the acute exacerbation phase)
  6. Improvement of neuropathy in eosinophilic polyangiitis granulomatosis (only when steroid drugs are ineffective)
Storage :

30°C or below

Shelf life :

2 years

Virus inactivation/reduction :
  • Plasma material PCR (NAT) testing for HIV, HBV, HCV, and parvovirus B19.
  • Ethanol fractionation
  • Sulfonation treatment
  • Nanofiltratin
  • Final product PCR (NAT) testing for HIV, HBV, HCV, and parvovirus B19.

Kenketsu Globulin “KMB”

(Intravenous Pepsin Treated Immuno Globulin (Human))

Kenketsu Globulin "KMB"
Indications :
  1. Hypogammaglobulinemia or agammaglobulinemia
  2. Combined use with antibiotics in severe infections
Storage :

10°C or below

Shelf life :

3 years

Virus inactivation/reduction :
  • Plasma material PCR (NAT) testing for HIV, HBV, HCV, and parvovirus B19.
  • Ethanol fractionation
  • Nanofiltratin
  • Final product PCR (NAT) testing for HIV, HBV, HCV, and parvovirus B19.

Kenketsu Albumin 20 “KMB”, 25 “KMB”

(Human Albumin)

Indications :
  1. Hypoalbuminemia due to loss of albumin (burn injuries, nephrotic syndrome, etc.) and reduced albumin synthesis (liver cirrhosis, etc.).
  2. Hemorrhagic shock
Kenketsu Albumin 20 “KMB”, 25 “KMB”
Storage :

30°C or below

Shelf life :

2 years

Virus inactivation/reduction :
  • Plasma material PCR (NAT) testing for HIV, HBV, HCV, and parvovirus B19.
  • Ethanol fractionation
  • Nanofiltratin
  • Liquid heat treatment (60°C, 10h)
  • Final product PCR (NAT) testing for HIV, HBV, HCV, and parvovirus B19.