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

Authors

  • 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
Further Information

Publication History

Received 03 December 1990

Accepted 12 June 1991

Publication Date:
26 July 2018 (online)

Preview

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.