Conjugation. The AFAIK2 product from the second 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. It is BioVectra’s understanding that the second engineering batch will be used as the toxicological batch. As such this batch will be used for the early stability study, as the batch prior to the clinical batch and a portion of this batch will allocated accordingly. The final product will be released against the same tests as proposed for the future clinical batch. Site cGMP API Facility, Class 100K clean room Time 2 days Documentation Batch records and notebooks to prepare product against target specifications, QC test methods and procedures. Deliverables 50 grams L-DOS47, Completed batch records, QC reports Development report, 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)