Heparin Small Pool High Yield Purified Factor VIII: In Vivo Recovery and Half-Life of Routinely Produced Freeze-Dried Concentrate

1984 ◽  
Vol 51 (01) ◽  
pp. 012-015 ◽  
Author(s):  
C T Smit Sibinga ◽  
S M G J Daenen ◽  
G W van Imhoff ◽  
A Maas ◽  
P C Das
Keyword(s):  
Side Effects ◽  
Factor Viii ◽  
Half Life ◽  
High Yield ◽  
Freeze Dried ◽  
Acute Side Effects ◽  
Significant Difference ◽  
Small Pool ◽  
Process Work

SummaryNew approaches and techniques for improving source material collection and Factor VIII production at Blood Bank level have been reported recently.Heparin has been shown to be of importance in increasing yields and stability of FVIII in the purification and concentration process. Work has been done to develop on a routine scale the heparin double cold precipitation technique for the production of a freeze-dried high yield purified FVIII concentrate.The product has been tested clinically in 4 severe hemophilia A patients for recovery, half-life and acute side-effects, using two dosages over 8 infusions. There was no significant difference between the two dosages. Mean recovery 99.1% and mean halflife 8 hr, ranging from 6.5 to 10.3 hr.No side-effects were observed.These results justify further exploration of the potential of heparin for high yield purified FVIII production.

Factor VIII With Monophasic Degradation, Produced by a New Fastthawing Method

1979 ◽  
Author(s):  
M. Ezoan ◽  
J.F. Hansen ◽  
J. Gormsen
Keyword(s):  
Factor Viii ◽  
Large Scale ◽  
High Yield ◽  
Scale Production ◽  
Large Scale Production ◽  
Freeze Dried ◽  
Labile Component ◽  
Small Pool ◽  
One Year

A new method has been developed for the large-scale production of cryopre-cipitate with a high yield of factor VIII. The freeze-dried factor VIII product has a solubility comparable to that of intermediate purified products and snows a remarkable in vivo stability. These improvements have been mainly accomplished by using a fast thawing method based on energy transfer through microwaves. Deep-frozen plasma bags (200 ml) are thawed in less than 10 min. with the temperature no where exceeding 4°C. In our routine production of freeze-dried, small-pool cryoprecipitate the yield of factor VIII is about 450 Units/liter of plasma. The concentration of the dissolved product is high being at least 2.0 Units/ml. This factor VIII concentrate has been used for home treatment for about one year, Clinical studies have snown a mean factor VIII recovery of 99.7% and a loss in activity of only 25% during the first 5 hours. The degradation follows a single exponential decay with time. This result indicates the absence of a labile component of factor VI VIII, which is usually observed along with the more stable component.

HALF-LIFE AND IN-VIVO RECOVERY OF HEATED FACTOR VIII CONCENTRATES

The Lancet ◽  
1986 ◽  
Vol 328 (8506) ◽  
pp. 571-572 ◽  
Author(s):  
M. Morfini ◽  
A. Messori ◽  
G. Longo ◽  
S. Cinotti ◽  
M. Matucci ◽  
...  
Keyword(s):  
Factor Viii ◽  
Half Life ◽  
Factor Viii Concentrates ◽  
In Vivo Recovery

scholarly journals Assessing the Performance of Extended Half-Life Coagulation Factor VIII, FC Fusion Protein by Using Chromogenic and One-Stage Assays in Saudi Hemophilia A Patients

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Tarek M. Owaidah ◽  
Hazzaa A. Alzahrani ◽  
Nouf S. Al-Numair ◽  
Abdulmjeed O. Alnosair ◽  
Amelita M. Aguilos ◽  
...  
Keyword(s):  
Factor Viii ◽  
Half Life ◽  
Hemophilia A ◽  
Coagulation Factor ◽  
Time Interval ◽  
One Stage ◽  
Chromogenic Assay ◽  
Significant Difference ◽  
Mean Differences ◽  
The One

Background. The one-stage assay is the most common method to measure factor VIII activity (FVIII : C) in hemophilia A patients. The chromogenic assay is another two-stage test involving purified coagulation factors followed by factor Xa-specific chromogenic substrate. Aim. This study aimed to assess the discrepancy and correlation between the chromogenic and one-stage assays in measuring FVIII : C levels in hemophilia patients receiving Extended Half-Life Elocta® as a recombinant extended half-life coagulation factor. Methods. We performed a study comparing the measurements of FVIII : C levels by the chromogenic versus the one-stage assays at different drug levels. Data of FVIII : C levels, dosage, and the time interval from administration to measurement were retrieved from the hospital records. The correlation, mean differences, and discrepancy between the two assays were calculated. The linear regression analysis was used to predict the time interval till reaching 1% FVIII : C. Results. Fourteen patients with 56 samples were included in the study. Of them, 13 patients were receiving Elocta® as a prophylactic, while one was receiving Elocta® on demand. One-third of these samples showed a discrepancy between the chromogenic and one-stage assays. The two assays were well correlated. Mean differences were significant at the individual and the time interval level. The time since the last Elocta® injection could significantly predict FVIII : C levels (β = 0.366, P<0.001). Conclusion. Our findings suggested a significant difference between both methods; the FVIII : C levels measured by the one-stage assay were less than those estimated by the chromogenic assay. However, the measurements of FVIII levels by the two assays were well correlated but discrepant in one-third of the samples. The levels of FVIII : C reach 1% after 5.4 days since the last Elocta® administration.

HIGH-YIELD METHOD OF PRODUCTION OF FREEZE-DRIED PURIFIED FACTOR VIII BY BLOOD BANKS

The Lancet ◽  
1981 ◽  
Vol 318 (8244) ◽  
pp. 449-450 ◽  
Author(s):  
C.Th. Smit Sibinga ◽  
H. Welbergen ◽  
P.C. Das ◽  
Brenda Griffin
Keyword(s):  
Factor Viii ◽  
High Yield ◽  
Freeze Dried ◽  
Blood Banks ◽  
Method Of Production

Pharmacokinetic Properties of Recombinant Factor VIII Compared with a Monoclonally Purified Concentrate (Hemofil® M)

1992 ◽  
Vol 68 (04) ◽  
pp. 433-435 ◽  
Author(s):  
M Morfini ◽  
G Longo ◽  
A Messori ◽  
M Lee ◽  
G White ◽  
...  
Keyword(s):  
Factor Viii ◽  
Half Life ◽  
Hemophilia A ◽  
Recombinant Dna ◽  
Volume Of Distribution ◽  
Pharmacokinetic Properties ◽  
Recombinant Fviii ◽  
Reported Data ◽  
In Vivo Recovery

SummaryA recombinant FVIII preparation, Recombinate™, was compared with a high-purity plasma-derived concentrate, Hemofil® M, in 47 hemophilia A patients in a cross-over evaluation of pharmacokinetic properties. The recombinant material showed a significantly lower clearance, volume of distribution, and higher in vivo recovery, but a similar half-life to the plasma-based product.In a comparison with reported data from other standard concentrates, the recombinant preparation exhibited potentially better pharmacokinetic properties in that its clearance was slower and its half-life was longer.We conclude that the recombinant DNA method of preparation does not adversely affect the biological and pharmacological characteristics of the factor VIII molecule.

In vivo Characteristics of Thaw Siphon Cryoprecipitate Compared to Other Factor VIII Preparations

1980 ◽  
Vol 43 (01) ◽  
pp. 025-027 ◽  
Author(s):  
F Toolis ◽  
G McKay ◽  
C V Prowse
Keyword(s):  
Factor Viii ◽  
Half Life ◽  
Immediate Recovery

Summary5 severe haemophiliacs were infused with cryoprecipitate prepared by the continuous thaw-siphon technique, with cryoprecipitate prepared by overnight thawing and with intermediate-purity factor VIII concentrate. All 3 preparations gave a similar mean half-life for coagulant factor VIII of approximately 10 hours. The immediate recovery of this activity was similar for the 2 cryoprecipitates, but higher for the purified concentrate.

In Vivo Recovery of Factor VIII: A Comparison of One-Stage and Two-Stage Assay Methods

1979 ◽  
Vol 42 (04) ◽  
pp. 1230-1239 ◽  
Author(s):  
I M Nilsson ◽  
T B L Kirkwood ◽  
T W Barrowcliffe
Keyword(s):  
Factor Viii ◽  
Half Life ◽  
In Vitro Assays ◽  
Two Stage ◽  
One Stage ◽  
Significant Difference ◽  
Assay Methods ◽  
The One ◽  
Fraction I

SummaryThe recovery and half-life of VIII: C in the plasma of severely haemophilic patients was measured by one-stage and two-stage assays after injection of two Factor VIII concentrates (Hemofil, Hyland and Fraction I-O, Kabi). Plasma volumes were measured with an Evans� Blue technique, and both concentrates and post-infusion samples were measured against the same plasma standard.There was a highly significant difference in recoveries estimated by the two assay methods. The one-stage assays gave the most consistent results, in that the average recovery was 100%, whereas the two-stage assays gave only about 80% of the value expected from in vitro assays. There was no difference in recoveries between the two concentrates.The two-stage assays gave a slightly shorter half-life than the one-stage assays, and the half-life of Hemofil was also shorter than that of Fraction I-O.

Use of Porcine Factor VIII in the Management of Seventeen Patients with Factor VIII Antibodies

1984 ◽  
Vol 51 (03) ◽  
pp. 379-384 ◽  
Author(s):  
Loredana Gatti ◽  
Pier Mannuccio Mannucci
Keyword(s):  
Side Effects ◽  
Factor Viii ◽  
Surgical Procedures ◽  
Post Partum ◽  
Cross Reactivity ◽  
Severe Thrombocytopenia ◽  
Therapeutic Choice ◽  
The Mean ◽  
In Vivo Recovery

SummaryA polyelectrolyte-fractionated porcine factor VIII concentrate was given to 16 hemophiliacs with anti-F VIII antibodies (Ab) and to a woman with post-partum-acquired Ab during 24 courses of treatment including three major surgical procedures. Before treatment, antiporcine F VIII Ab was always lower than antihuman F VIII Ab, with a median cross reactivity of 32%. After treatment, the mean rise in F VIII was 1.5 U/dl/Unit infused/Kg b.w. and in vivo recovery was 50% of the theoretical values. Anamnestic rises in anti-porcine F VIII Ab (3 × the baseline titer) were seen after 9 of 22 courses of treatment with porcine F VIII only; similar rises in anti-human F VIII Ab, after 6 courses of treatment; median cross reactivity did not change significantly. Lower than expected increases in plasma F VIII without marked changes in Ab titers and severe thrombocytopenia occurred during surgery in two patients. Porcine F VIII is a rational and effective therapeutic choice for patients who have anti-human Ab titers above 10 U/ml; it can solve clinical situations that would otherwise be very difficult to manage; anamnesis is perhaps less frequent than after human F VIII; however, the incidence of thrombocytopenia, resistance and other side- effects is still higher than desirable.

Preparation and use of a Combined Reagent for the Two-Stage Assay of Factor VIII Procoagulant Activity

1979 ◽  
Author(s):  
N. Pettet ◽  
V.K. Hirst
Keyword(s):  
Factor Viii ◽  
Close Agreement ◽  
Comparative Assessment ◽  
Procoagulant Activity ◽  
Factor V ◽  
Two Stage ◽  
Freeze Dried ◽  
Significant Difference ◽  
Plasma Factor ◽  
Assay Methods

Activated serum, bovine factor V and phospholipid, diluted In barbitone sodium saline pH 7.3 were prepared as a pooled reagent and freeze-dried in aliquots. Normal plasma with CPD as anticoagulant was used as the substrate. The reagent was easily prepared, is convenient to use and has been assessed in three independent trials. Repeated assays performed using the International standard for factor VIII and the British Standards for plasma factor VIII and concentrate factor VIII provided combined potency estimates which showed no significant difference from the values stated for these standards. In a group study, where seven participants performed two-stage assays using their normal reagents and techniques, the potency estimates obtained by RPL using the combined reaqent were in close agreement with those obtained by workers with other assay methods. Quality control measurements of procoagulant activity in factor VIII concentrate performed in duplicate at RPL and plasma Fractionation Laboratory PFL , Oxford over a period of several months provided a satisfactory comparative assessment of the combined reagent assay and the two-stage factor VIII assay used at PFL. Use of the combined reagent in a simplified two-stage assay has been studied and its suitability in automatic techniques has beer shown to be acceptable.

Evaluation of the safety, recovery, half-life, and clinical efficacy of antithrombin III (human) in patients with hereditary antithrombin III deficiency. Cooperative Study Group [see comments]

Blood ◽  
1990 ◽  
Vol 75 (1) ◽  
pp. 33-39 ◽  
Author(s):  
D Menache ◽  
JP O'Malley ◽  
JB Schorr ◽  
B Wagner ◽  
C Williams ◽  
...  
Keyword(s):  
Half Life ◽  
Antithrombin Iii ◽  
Clinical Symptoms ◽  
Cooperative Study Group ◽  
Significant Difference ◽  
At Iii ◽  
Thrombotic Complications ◽  
Antithrombin Iii Deficiency

Antithrombin III (Human) (AT III) was administered to 18 patients with documented hereditary AT III deficiency. In eight patients with no ongoing clinical symptoms of thrombosis, the percent increase per unit AT III infused per kilogram of body weight ranged from 1.56% to 2.74%, and the half-life from 43.3 to 77.0 hours. No significant difference was noted between patients receiving and those not receiving coumarin therapy. In clinically ill patients, the in vivo recovery was significantly lower and ranged from 0.64% to 1.90% increase per unit AT III infused/kg. Efficacy of AT III was evaluated in 13 patients for the prevention or treatment of thrombosis. AT III was efficacious as assessed by the absence of thrombotic complications after surgery and/or parturition, and the nonextension and nonrecurrence of thrombosis in patients exhibiting an acute thrombotic episode. No side effects were noted. Follow-up studies indicated no hepatitis B seroconversion and no alanine aminotransferase elevations in patients who were not transfused with other blood products.

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