Conjugation. The AFAIK2 product from the first engineering batch will be conjugated with 50 grams of high purity urease. The final product will be prepared in a stabilized buffer solution, the nature of the ingredients to be provided by Helix. The conjugated product will be available for use by Helix as well as be available to complete the qualification for the majority of the release tests, with others as FIO since the stability of the product prior to conjugation has not been established. The product will also be used for packaging trials of the bulk drug substance in the selected packaging container for shipment to the formulator. Site cGMP API Facility, Class 100K clean room Time 2 days Documentation Preliminary batch records and notebooks to prepare product against target specifications, draft QC test methods and procedures. Deliverables 50 grams L-DOS47 , Completed batch records, QC reports Development report, Draft Certificate of analysis
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)