Glossary entry

английский term or phrase:

BRIDGING OF HOST CELL PROTEIN METHODS

русский translation:

сопоставимость методов определения белков клетки-хозяина

    The asker opted for community grading. The question was closed on 2019-06-14 07:54:07 based on peer agreement (or, if there were too few peer comments, asker preference.)
Jun 10, 2019 08:26
4 yrs ago
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английский term

BRIDGING OF HOST CELL PROTEIN METHODS

английский => русский Медицина Медицина: Фармацевтика Анализы серий
BRIDGING OF HOST CELL PROTEIN METHODS
BRIDGING OF RESIDUAL PROTEIN A METHODS
BRIDGING OF CDC BIOASSAYS

3.3 BRIDGING OF HOST CELL PROTEIN METHODS

Comparison of methods

Residual Host Cell Proteins (HCP) quantitation is determined using the Immunoenzymatic Assay for the measurement of Chinese Hamster Ovary (CHO) Host Cell Protein. Previous version of the assay used a F550 ELISA kit (commercial assay distributed by Cygnus technologies, Inc). A process specific HCP ELISA kit is implemented to replace the commercial ELISA kit F550 used for early development phases. Thus the previously used method employing “F550” ELISA kit (commercial assay distributed by Cygnus technologies, Inc) was substituted by “F720” ELISA kit (Sanofi’s proprietary kit designed by Cygnus Technologies, Inc).

Proposed translations

23 мин
Selected

сопоставимость методов определения белков клетки-хозяина

В этом контексте bridging означает сопоставимость, сравнимость, согласованность, а лучшим англ. синонимом является слово reconciliation.

Смысл хорошо объяснен здесь:
To calculate a relative potency of a vaccine batch, a reference batch is needed. The problem is that the reference batch has a life span of 3-4 years (before running out of stock, for example), and a vaccine has a commercial life of about 30 years. Bridging studies are used to estimate a correction factor between a new and an old reference batch. Statistical methodologies for a successful bridging are widely misunderstood. This talk presents an overview of the statistical methods applied to assay bridging
https://www.pegsummit.com/Bioassays-Conference
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