Member experiences of campaign manufacture with lyophilization processes
The topic of campaign manufacture for lyophilization processes was discussed by the BioPhorum Lyophilization group and the following is a summary of the approach taken by the major biopharmaceutical companies with experience of campaign manufacture who are members of the group.
Performing a campaign of lyophilization batches involves manufacturing a series of batches without the associated sterilization and leak rate normally performed for each batch. Operating in this way will increase capacity and has doubled lyophilization capacity for one of our members. To be able to operate campaigns it is vital to understand the product profile and the risks associated with this operation. One manufacturer uses this approach for a high-volume product with a short cycle time.
Campaigns are restricted to the same vial size of the same product. Complex and long cycle times are likely to be unsuitable as are those associated with any type of vial blow out.
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