Production batch records (PBRs) developed during process development are used to transfer the process almost seamlessly to the GMP Suite. Prior to executing a production run the PBRs must be approved by the client. Fermentation is performed as described by the batch records with only minor adjustments to compensate for scaling up. Alternatively, PBRs provided by the client are followed. Fermentations are monitored to assure conditions correspond to those defined in the PBRs. During fermentation, samples are collected and subjected to in-process testing such as optical density, wet cell weight, off-line pH , SDS-PAGE, Western blot, or ELISA. Cultured product may be harvested using centrifugation or membrane technology (micro- or ultra-filtration). Upon harvest, material is immediately transferred to the purification lab for downstream processing or is frozen for storage or shipping.
Upstream capabilities:
- Shake flask to 150L working volume
- Low or high cell density fermentations
- Mechanical cell disruption
- Disc-stack centrifugation
- Micro- and ultrafiltration tangential flow filtration (TFF)
- Temperature controlled and monitored product storage