Centocor has recently started to manufacture monoclonal antibody product intermediate at facilities in addition to their main facilities in Malvern PA and Leiden, The Netherlands. Precipitate is known to be present in the feed stream, and the relative amounts of precipitate can differ between main production facilities.

Currently, product intermediate is produced at the additional locations and shipped for further processing at both main manufacturing plants, however because processed intermediate contains variable amounts of precipitate, it was necessary to evaluate the degree of precipitate formation produced at the off site locations.

A laboratory scale study was executed in order to assess the degree of precipitate formation in product produced to ensure the product would be suitable for downstream processing at the main facilities.

The results of the study show a correlation of precipitation to upstream processing events at the different manufacturing facilities. These results enabled informed decisions about further downstream processing of intermediate product produced at the off site locations.