Pilot Fermentation(s) Utilizing R Media. To confirm the results obtained at the shake flask stage, a pilot scale fermentation of the AFAIK2 will be performed at a 30L fermentor scale. These runs will also serve as technical transfer runs to qualify a disk stack centrifuge to be used in the process for cell separation as well as further optimize and scale up the use of the microfluidizer for cell lysis. The downstream processing will be taken to such a point where BioVectra can confirm comparable AFAIK2 purity to the batches prepared using LB media. Additional improvements for the DSP portion of the process can be studied using these runs to supply product (i.e. addition of protease inhibitors). The fermentation parameters confirmed in this batch will be used to prepare the protocols and batch records for the 500 L scale. Site cGMP API Facility Fermentor 30 L (22L working) Centrifuge Westfalia Whisperfuge Microfluidizer Microfluidics M-110EH Time 8 weeks Documentation Approved Protocol Deliverables Lab Development Report/Lab Notebook documentation
Appears in 3 contracts
Sources: CGMP Process Development, Scale Up and Clinical Supplies Manufacturing Agreement (Helix BioPharma Corp), CGMP Process Development, Scale Up and Clinical Supplies Manufacturing Agreement (Helix BioPharma Corp), CGMP Process Development, Scale Up and Clinical Supplies Manufacturing Agreement (Helix BioPharma Corp)