INVESTIGADORES
COUTO Alicia Susana
artículos
Título:
Batch-to-Batch consistency of human derived gonadotrophin preparations compared to recombinant preparations.
Autor/es:
WOLFENSON CLAUDIO,; GROISMAN JOSE,; COUTO ALICIA S.,; HEDENFALK MARTIN,; CORTVRINDT RITA G.,; SMITZ JOHAN E.J.,; JESPERSEN SONJA.
Revista:
REPRODUCTIVE BIOMEDICINE ONLINE
Editorial:
Reproductive Healthcare Ltd-
Referencias:
Lugar: England; Año: 2005 vol. 10 p. 442 - 454
ISSN:
1472-6483
Resumen:
Different gonadotrophin preparations derived from human urine or manufactured by recombinant technology are currently
used in clinical practice for the treatment of infertility. It has been widely assumed that gonadotrophin products
manufactured by recombinant technology have better batch-to-batch consistency compared with human-derived
preparations and that this potentially will be shown to provide a more constant clinical response, but there is little evidence
for either statement. This study compared the batch-to-batch consistency between urinary-derived and recombinant
manufactured gonadotrophin preparations using standard analytical techniques, as well as a novel in-vitro follicle bioassay
to evaluate the consistency of the biological response at the target organ. Oligosaccharide isoform profiling, immunoassay
testing, size exclusion chromatography analysis and in-vitro bioassay testing of urinary derived gonadotrophin preparations
(MENOPURR and BRAVELLER) confirm that these products display a high degree of batch-to-batch consistency, similar
to recombinant FSH (GONAL-fR) either filled by mass or bioassay. The data also suggest that the batch-to-batch variation
is independent of the manufacturing procedure (filled-by-bioassay or filled-by-mass) for the recombinant preparation
(Gonal-f), but that the total FSH bioactivity delivered from a single dose preparation after reconstitution differs between the
two manufacturing procedures.R and BRAVELLER) confirm that these products display a high degree of batch-to-batch consistency, similar
to recombinant FSH (GONAL-fR) either filled by mass or bioassay. The data also suggest that the batch-to-batch variation
is independent of the manufacturing procedure (filled-by-bioassay or filled-by-mass) for the recombinant preparation
(Gonal-f), but that the total FSH bioactivity delivered from a single dose preparation after reconstitution differs between the
two manufacturing procedures.R) either filled by mass or bioassay. The data also suggest that the batch-to-batch variation
is independent of the manufacturing procedure (filled-by-bioassay or filled-by-mass) for the recombinant preparation
(Gonal-f), but that the total FSH bioactivity delivered from a single dose preparation after reconstitution differs between the
two manufacturing procedures.