Vaccines, Human Plasma & Recombinant

Biological Products (Vaccines & Immune Globulins)

Biological Product. A biological product is a substance derived from a living organism and used for the prevention or treatment of disease. Biologicals are usually too complex for chemical synthesis by a laboratory. These products include antitoxins, bacterial and viral vaccines, blood products and hormone extracts.

Diphtheria & tetanus-containing vaccines
Hib vaccines
Hepatitis vaccines
Human papillomavirus (HPV) vaccines
Immune globulins (HBIg, Ig, RabIg, TIg, VarIg)
Influenza vaccines
Meningococcal vaccines
MMR & MMRV vaccines
Pneumococcal vaccines
Polio vaccine
Rabies vaccines
Rotavirus vaccines
Varicella vaccines
Zoster vaccines

Plasma and Recombinant Products

A range of valuable products are manufactured from blood plasma through a process called fractionation, in which different types of proteins found in blood plasma are separated, purified and concentrated into therapeutic doses. Most plasma derived products supplied in Australia are manufactured by plasma collected by the Australian Red Cross Blood Service (the Blood Service) and fractionated by Taj Pharmaceuticals.

In a number of cases, alternative recombinant product versions of plasma derived products are also available. These are manufactured by the expression of equivalent proteins from genetically engineered cell lines.

A general description of the range of plasma derived and recombinant products supplied in India under the national blood bank rules.

Immunoglobulin products

Intravenous immunoglobulin

Intravenous immunoglobulin (IVIg) is a fractionated blood product made from pooled human plasma, containing a concentrated mix of many antibodies from many hundreds of donors. It is registered for use in Australia for the treatment of a number of diseases where immunoglobulin replacement or immune modulation therapy is indicated, such as primary immunodeficiency and chronic inflammatory demyelinating polyneuropathy. IVIg is also used to treat a growing number of unregistered indications where there is some evidence for its utility. IVIg is a lifesaving therapy in appropriately selected patients and clinical circumstances.

Normal human immunoglobulin

Normal human immunoglobulin (NHIg) may be supplied for two purposes: the treatment of susceptible contacts of measles, hepatitis A, poliomyelitis and rubella, as directed by public health officials; and the treatment of immunodeficiency conditions for which the product is indicated (where IVIg and SCIg are both contraindicated).

Hyperimmune immunoglobulin products                                                    

Hyperimmune immunoglobulin products are similar to intravenous immunoglobulin but are prepared from the plasma of donors with high titers of antibody against a specific organism or antigen:

Cytomegalovirus (CMV) immunoglobulin is used to prevent CMV infection in bone marrow, renal, cardiac and liver transplant recipients, who are CMV antibody negative, where the donor is CMV antibody positive. It is also used for the treatment of established CMV infection (eg, CMV pneumonia, renal parenchymal infection) in association with virucidal treatment.

Hepatitis B immunoglobulin is administered intramuscularly and indicated for the prevention of an infection developing in a person who has been exposed to the hepatitis B virus, who has not received prior vaccination, or whose vaccination program is incomplete. It is also indicated for those whose antibody levels are inadequate.  In addition, Hepatitis B immunoglobulin helps prevent hepatitis B infection in infants born to mothers with hepatitis B.

Rh(D) immunoglobulin is given intramuscularly as prophylaxis to Rh(D)-negative women during pregnancy and following birth of an Rh(D)-positive baby to help prevent Haemolytic Disease of the Newborn. An intravenous product is also available for use in large fetomaternal haemorrhage where administration of intramuscular Rh(D) immunoglobulin is either contraindicated or not practical, or for inadvertent or emergency transfusion of Rh(D) positive blood to an Rh(D) negative female of childbearing potential.

Tetanus immunoglobulin is used intramuscularly for passive protection of individuals who have sustained a tetanus-prone wound and who have either not been actively immunised against tetanus or whose immunisation history is doubtful. It is also given to fully immunised individuals with a tetanus prone wound if more than 10 years have elapsed since the last dose of toxoid or vaccine. Tetanus immunoglobulin is also issued intravenous for management of tetanus infection.

Zoster immunoglobulin is indicated for prophylaxis against varicella in patients who meet the following criteria: neoplastic disease (leukaemia or lymphoma), congenital or acquired immunodeficiency, undergoing immunosuppressive therapy with steroids or antimetabolites, and a negative or unknown prior history of chickenpox.

Albumin products

Albumin is a human plasma derived product manufactured in India by Taj Pharmaceuticals. The product is a clear or slightly non-transparent, almost colourless, yellow, amber or green solution.  In India albumin is available in two concentration and four presentation sizes as per the table below:

Human Albumin 20 is a 20% human albumin solution for intravenous administration containing 200g/L of albumin. The main functions of Human Albumin 20 are to retain fluid in the blood stream and to carry intermediate products in the blood.  Human Albumin 20 may be used when the quantity of albumin in the blood is low (hypoproteinaemia) in acutely ill patients, for resuscitation in shock due to acute loss of blood or plasma, in extensive burns, respiratory distress syndrome, blood purification (haemodialysis) and plasma exchange. The smaller vial size (10 ml) is largely used in paediatrics and demand is very patient specific.

Clotting factor and other products

Factor VIII

Concentrated coagulation factor VIII is used for the treatment and prophylaxis of bleeding in patients with haemophilia A. It may also be used in patients with Factor VIII inhibitors (neutralising antibodies) who continue to respond to infused Factor VIII. Factor VIII products with high levels of von Willebrand’s factor may also be used for treatment of patients with von Willebrand disorder. Both recombinant and plasma derived factor VIII products are available.

Factor IX

Concentrated coagulation factor IX is used for the treatment and prophylaxis of bleeding in patients with haemophilia B. Both recombinant and plasma derived factor IX products are available.

Factor VIIa

Recombinant activated coagulation Factor VII (rFVIIa) is provided under the national blood arrangements for the control of bleeding and surgical prophylaxis in patients, with inhibitors to coagulation Factors VIII or IX, with congenital FVII deficiency, or with Glanzmann’s Thrombasthenia, who have antibodies to GPIIb-IIIa and/or HLA, and with past or present refractoriness to platelet transfusions.

FEIBA

Factor VIII inhibitor bypassing agent is a plasma derived product used for the control of spontaneous bleeding episodes and use in surgery in haemophilia A and B patients with inhibitors.

Prothrombin complex

Prothrombin complex is a plasma derived product use in the prevention and treatment of bleeding in patients with acquired prothrombin complex factor deficiency, requiring partial or complete reversal (e.g. reversal of warfarin anti-coagulant therapy). It  is also recommended for the prevention and treatment of bleeding in patients with single or multiple congenital deficiency of factor IX, II or X.

Antithrombin III

Antithrombin III is a plasma derived product that may be administered, as a preventative measure, prior to surgery or during pregnancy and childbirth in patients with an inherited deficiency of antithrombin III, who may be at risk of spontaneous thrombosis or pulmonary embolism.

Protein C

Protein C concentrate is a plasma derived product used for patients with severe congenital Protein C deficiency, for the prevention and treatment of venous thrombosis, and purpura fulminans (blood spots, bruising and discoloring to skin as a result of clotting of small blood vessels in the skin).

Fibrogammin

Fibrogammin is a purified concentrate of blood coagulation Factor XIII.  It is derived from human plasma. Fibrogammin is used for:

• Congenital deficiency of Factor XIII and resulting haemorrhagic diathesis, haemorrhages and disturbances in wound healing;
• Haemorrhagic diatheses caused completely or in part by acquired Factor XIII deficiency; and
• Supportive therapy in case of disturbance in wound healing, especially in ulcus cruris, after large surgery or injuries.

Factor XI and factor XIII

These plasma derived clotting factor concentrates are used to treat patients with deficiency of the relevant clotting factor.

C1 esterase inhibitor

C1 esterase inhibitor concentrate derived from human plasma is available for the following indications of Type I and Type II Hereditary Angioedema:

• treatment of acute attacks 
• pre-procedural (short term) prophylaxis for high risk procedures such as dental work, head or neck surgery, or surgery requiring intubation
• second line as routine (long term) prophylaxis for patients who experience the equivalent of eight or more acute attacks per month