Purification of AFAIK2 and Conjugation Sample Clauses

Purification of AFAIK2 and Conjugation. Downstream processing of AFAIK2 will be completed based on the process optimized by the engineering batches. The AFAIK2 product from this batch will be conjugated with 50 grams of high purity urease. The product from this batch will be used for Clinical studies. The final product will be prepared in a stabilized buffer solution, the nature of the ingredients to be provided by Helix. This batch will be filled by BioVectra to the final bulk packaging container and sampled accordingly for release. Stability samples will be required from this batch. The final product will be released against the same criteria as developed for the second engineering batch. Site cGMP API Facility, Class 100K clean room Centrifuge Westfalia Microfluidizer Microfluidics Time 17 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 6.1 Target Specifications for Purified Urease 6.2 Target Specifications for AFAIK2
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