Blood safety and the choice of anti‐hemophilic factor concentrate

Valentino, Leonard A.; Oza, Veeral

doi:10.1002/pbc.20895

Cited by 7 publications

(11 citation statements)

References 83 publications

(88 reference statements)

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“…Problems such as these can be mitigated by providing previously untreated patients with products that have been manufactured without the addition of animalderived components. Such products are not only an obvious choice for young, previously-untreated and unexposed patients, but should also be considered for patients with existing infections (such as HIV, HBV, or HCV) who must be concerned about the introduction of additional pathogens, which could further complicate a pre-existing infection [69].…”

Section: Improving Clinical Outcomes Through Plasma-free Therapeuticsmentioning

confidence: 99%

Emerging trends in plasma‐free manufacturing of recombinant protein therapeutics expressed in mammalian cells

Grillberger

Kreil

Nasr³

et al. 2009

Biotechnology Journal

134

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Mammalian cells are the expression system of choice for therapeutic proteins, especially those requiring complex post-translational modifications. Traditionally, these cells are grown in medium supplemented with serum and other animal-or human-derived components to support viability and productivity. Such proteins are also typically added as excipients and stabilizers in the final drug formulation. However, the transmission of hepatitis B in the 1970s and of hepatitis C and HIV in the 1980s through plasma-derived factor VIII concentrates had catastrophic consequences for hemophilia patients. Thus, due to regulatory concerns about the inherent potential for transmission of infectious agents as well as the heterogeneity and lack of reliability of the serum supply, a trend has emerged to eliminate the use of plasma-derived additives in the production and formulation of recombinant protein therapeutics. This practice began with products used in the treatment of hemophilia and is progressively expanding throughout the entire industry. The plasma-free method of producing recombinant therapeutics is accomplished by the use of both cell culture media and final product formulations that do not contain animal-or human-derived additives. A number of recombinant therapeutic proteins for the treatment of several different diseases have been produced by plasma-free processes, with the objective of improving safety by eliminating blood-borne pathogens or by reducing immunogenicity. This review describes the factors that drove the development of plasma-free protein therapeutics and provides examples of advances in manufacturing that have made possible the removal of human and animal-derived products from all steps of recombinant protein production.

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Section: Improving Clinical Outcomes Through Plasma-free Therapeuticsmentioning

confidence: 99%

Emerging trends in plasma‐free manufacturing of recombinant protein therapeutics expressed in mammalian cells

Grillberger

Kreil

Nasr³

et al. 2009

Biotechnology Journal

134

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“…The choice as to the product to use for prophylaxis in patients with inhibitors is limited compared with the array of therapeutics available for patients without inhibitors [3]. Plasma‐derived prothrombin complex concentrates (PCC), the activated PCC (aPCC) and recombinant FVII activated (rFVIIa) bypass the inhibitor to promote coagulation.…”

Section: Prophylaxismentioning

confidence: 99%

“…This article reviews different haemostatic products [3] and protocols for control of haemorrhage (prophylaxis) and for synovectomy in haemophilic patients with inhibitors, particularly radioactive synoviorthesis.…”

Section: Introductionmentioning

confidence: 99%

Prophylaxis and treatment of chronic synovitis in haemophilia patients with inhibitors

2007

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Prophylaxis is paramount to try to avoid the development of haemophilic synovitis. The best treatment for synovitis in patients with inhibitors is radioactive synoviorthesis (rhenium for ankle and elbows, yttrium for knees). With both methods (prohylaxis and radioactive synoviorthesis), we can delay the development of severe haemophilic arthropathy, that eventually will require major orthopaedic surgery.

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“…In addition, recombinant FVIII and later, recombinant FIX concentrates were developed. As a result, there has been no transmission of clinically relevant infectious agents in coagulation concentrates for over 20 years 2,3. The last remaining major clinical hurdle in the treatment of hemophilia is the development of inhibitors, ie, an immune response to infused coagulation factors.…”

Section: Introductionmentioning

confidence: 99%

Optimal use of recombinant factor VIIa in the control of bleeding episodes in hemophilic patients

Puetz

2010

DDDT

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One of the last remaining clinical hurdles in the treatment of people with hemophilia is the development of inhibitors. Alloantibodies or autoantibodies directed at coagulation factors render the infusion of coagulation factor concentrates ineffective, and alternative means must be used to achieve hemostasis. Recombinant factor VIIa (rFVIIa) was developed to control bleeding episodes in hemophilic patients with inhibitors. Clinical efficacy in achieving hemostasis in inhibitor patients was demonstrated by a compassionate-use protocol, as well as in randomized controlled trials. To date, over 1.5 million doses of rFVIIa have been given to inhibitor patients, with an excellent efficacy and safety record. Because of its short half-life, alternative means of dosing and infusing rFVIIa have been explored and are reviewed here.

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Blood safety and the choice of anti‐hemophilic factor concentrate

Cited by 7 publications

References 83 publications

Emerging trends in plasma‐free manufacturing of recombinant protein therapeutics expressed in mammalian cells

Emerging trends in plasma‐free manufacturing of recombinant protein therapeutics expressed in mammalian cells

Prophylaxis and treatment of chronic synovitis in haemophilia patients with inhibitors

Optimal use of recombinant factor VIIa in the control of bleeding episodes in hemophilic patients

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