Bulk Harvest Testing

A bulk harvest or a fermentor harvest is the batch of cells, media and product which is taken from the manufacturing process at the end of the production process and prior to downstream purification activities. Regulations consider that this is the optimal time when samples should be taken for the detection of any contamination of the production process. There are a number of different production processes where a bulk harvest can consist of a single harvest or multiple harvests which are combined. The sample taken for bulk harvest testing should be consistent with the material used to create the drug product.

Time is of the essence when testing bulk harvest samples as these need to be shown to be free from contamination before further processing is possible. BioOutsource has developed a number of mechanisms to report assay results in as short a time as possible and where appropriate suggest replacement assays which can achieve the same regulatory requirements but in a much reduced turn around time. BioOutsource can report bulk harvest results within 16 days of receipt of sample.

Bulk harvest testing varies depending on product and regulatory guidelines. Generally it requires testing for microbes (sterility and mycoplasma) and a screen for contaminating virus (in vitro adventitious virus, retrovirus screen and specific viruses of concern by PCR). The required Biosafety testing services for bulk harvests are shown below:

Contact our biosafety experts to discuss your bulk harvest testing needs.

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