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Thromb Haemost 1991; 66(06): 730-733
DOI: 10.1055/s-0038-1646492
Original Article
Schattauer GmbH Stuttgart

In Vivo Recovery and Survival of Monoclonal-Antibody-Purified Factor VIII Concentrates

Carol K Kasper
1   The Department of Medicine, University of Southern California, and Orthopaedic Hospital, Los Angeles, California, USA
,
Hugh C Kim
2   The Department of Medicine, Robert Wood Johnson School of Medicine, New Brunswick, New Jersey, USA
,
Edward D Gomperts
3   The Department of Pediatrics, University of Southern California, and Children's Hospital of Los Angeles, Los Angeles, California, USA
,
Kenneth J Smith
4   The Departments of Pathology and Medicine, University of New Mexico, Albuquerque, New Mexico, USA
,
Phyllis M Salzman
5   The Rhone-Poulenc Rorer Central Research, Horsham, Pennsylvania, USA
,
Diane Tipping
5   The Rhone-Poulenc Rorer Central Research, Horsham, Pennsylvania, USA
,
Robert Miller
3   The Department of Pediatrics, University of Southern California, and Children's Hospital of Los Angeles, Los Angeles, California, USA
,
Robert M Montgomery
6   The Blood Center of Southeastern Wisconsin and Department of Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin, USA
› Author Affiliations
Further Information

Publication History

Received 03 December 1990

Accepted 12 June 1991

Publication Date:
26 July 2018 (online)

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Summary

In response to reports of discrepant in vitro assays of high-purity concentrates, a double-blind crossover study of in vivo recovery and half-life of two brands of monoclonal-antibody-purified factor VIII concentrates (Monoclate and Hemofil-M) was performed in 23 patients with hemophilia A. In vivo recoveries were close to values predicted from the labelled unitage when plasma samples were assayed by a one-stage method. When a two-stage assay was used, lower recoveries were calculated and the recovery with Hemofil-M was slightly but significantly lower than that with Monoclate. The concentrates were re-assayed in vitro by the two-stage method. Monoclate (which is assayed by the manufacturer using a two-stage method) contained 97% of the labelled potency and Hemofil-M (which is assayed by the manufacturer using a one-stage method) contained 81% of the labelled potency. Differences in in vitro and in vivo assay methods contribute to disparities between expected and observed factor VIII recovery. Clearance of Hemofil-M was significantly faster than that of Monoclate, but volume of distribution at the steady state, mean residence time, and plasma half-disappearance times of the two concentrates were not significantly different.

 

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