An overview of plasma fractionation

Burnouf, Thierry

doi:10.21037/aob.2018.05.03

Cited by 28 publications

(22 citation statements)

References 45 publications

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“…Plasmapheresis (source plasma) yields more plasma (450–880 ml) (WHO) [ 13 ] depending on regulations in the country of collection [ 14 ▪▪ , 15 , 16 ]. In the United States donation frequency is twice weekly with 2 days between and maximally 104 donations annually [ 9 ] but only 0.3% donate more than 100 times, 14% more than 50 times, whereas 49% donated 10 times or fewer annually [ 17 ].…”

Section: Plasma Collection and Immunoglobulin Manufacturementioning

confidence: 99%

Global immunoglobulin supply: steaming towards the iceberg?

Prévot¹,

Jolles

2020

Current Opinion in Allergy &Amp; Clinical Immunology

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Purpose of review This review describes how plasma is sourced for fractionation into plasma-derived medicinal products (PDMPs), such as immunoglobulin (Ig) together with differences between plasma from whole blood (recovered plasma) and from plasmapheresis (source plasma) in terms of global plasma supply. Specific areas of growth in immunoglobulin use are identified alongside novel therapies, which may reduce demand for some immunoglobulin indications. Recent findings There has been a 6--8% annual growth in immunoglobulin use. Secondary immunodeficiency alongside improved recognition and diagnosis primary immunodeficiency disorders are drivers whereas the novel neonatal Fc receptor inhibitors (FcRni) may reduce demand for some immunomodulatory indications. Summary There is a significant geographical imbalance in global supply of plasma with 65% collected in the United States. This results in a dependency of other countries on United States supply and argues for both more plasma supply and greater regionally balanced plasma collection. In addition, progress towards a transparent, regulated and well tolerated framework for the coexistence of unpaid and compensated plasma donations is needed as unpaid donation will not be sufficient. These discussions should be informed by the needs of patients for this life-saving therapy, the care of donors and the safety of plasma and PDMPs.

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Section: Plasma Collection and Immunoglobulin Manufacturementioning

confidence: 99%

Global immunoglobulin supply: steaming towards the iceberg?

Prévot¹,

Jolles

2020

Current Opinion in Allergy &Amp; Clinical Immunology

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“…3,4 Resulting human immunoglobulin products, both hyperimmune (or 'specific') and normal (or nonspecific) predominantly consist of IgG. 5 Hyperimmune immunoglobulin products include hepatitis B, tetanus, varicella-zoster and rabies immunoglobulins; each containing a known concentration of the particular antibodies. 6 The antibody specificities in normal polyvalent human immunoglobulins (IG) mirror those in the donor population.…”

Section: Introductionmentioning

confidence: 99%

The indications and safety of polyvalent immunoglobulin for post-exposure prophylaxis of hepatitis A, rubella and measles

Young

2019

Human Vaccines & Immunotherapeutics

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Derived from pooled blood donations, polyvalent immunoglobulins are used for post-exposure prophylaxis as one aspect of the public health management of hepatitis A, rubella and measles. This review summarizes the safety profile of these blood products and the current recommendations for their use for the prevention of hepatitis A, rubella and measles among people who have been exposed to these diseases. The current recommendations are drawn from the most recent publicly available national guidelines of the United States,

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“…Fractionation of human plasma provides a range of more than two dozen therapeutic proteins used worldwide. 11,12 For major bleeding, prothrombin complex is used to treat patients anticoagulated with vitamin K antagonists as well as factor Xa-related inhibitors. While currently approved only for congenital hypofibrinogenemia in the United States, fibrinogen has been proposed as an alternative to cryoprecipitate for severe acquired hypofibrinogenemia, for example, in trauma, postpartum hemorrhage, or cardiac surgery.…”

Section: Demandmentioning

confidence: 99%

“…IVIG and subcutaneous immunoglobulin are essential therapeutic products for chronic treatment of patients with primary and secondary immune deficiencies, such as those resulting from cancer chemotherapy and stem cell transplant. IVIG has numerous applications as an immunomodulatory therapy in such diverse disorders as idiopathic thrombocytopenic purpura, myasthenia gravis, 11,12 and chronic inflammatory demyelinating polyneuropathy. In addition, there are a number of investigational uses under study including Alzheimer disease 16 …”

Section: Demandmentioning

confidence: 99%