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Training of Samsung Analysts for Production of Rituximab Natalie Serdahl Vacaville QC-SAT To enable Samsung Biologics in Incheon, Korea to produce Rituximab, the five analysts from the facility will complete either their training runs on the reference standard or engineering runs. Once their results and method are approved by their trainers, they can move forward to begin qualification runs in Korea. Q12261 Bomi Seol SungHwa Cho EunJi Joe Hana Jung Tue Wed Thur Fri 7/21/2014 7/22/201 4 7/23/20 14 7/24/2014 7/25/2014 Q12350 Training Day 1: Susan Q12334 Trainin g Day 1: Jeff Demo, prep with Side by Side Testing Q12350 Training Day 2: Susan Q12334 Training Day 2: Finish up analyst training run, write up Q12261 Demo and Q+A: Susan Q12335 Training Day 1: Bruce Demo, Q+A and Analyst prep samples for 1st run Q12347 Training Day 1: Vanessa Theory in am, training run 1 in pm Q12345 Training w/ Jeff (abbreviated ) Q12347 Training Day 2: Vanessa Training run 1 Q12335 Training Day 3: Complete, analyze and writeup 1st run with Bruce Q12350 Trainin g Day 3: Susan Q12335 Training Day 2: Analysts load and run Mon Tue Wed Thur Fri 7/28/2014 7/29/201 4 7/30/20 14 7/31/2014 8/1/2014 Q12347 Training Day 3: Wrap up training run, integrati on and writeup in am, training run #2 Day 1 in pm All methods practic e runs, sandbox , critica l reagent prep, All methods practice runs, sandbox, critical reagent prep, etc. All methods practice runs, sandbox, critical reagent prep, etc. SSF SSF and Flight out of SFO (noon) Q12261 Clarity Opalescence and Coloration of Liquids Q12334 Ion- Exchange Chromatography Q12335 Peptide Map Q12345 Size Exclusion Chromatography Q12347Glycan Q12350 SDS-PAGE Task Q12350 SDS-PAGE: Bovine Serum Albumin (BSA) control was over loaded into the gel causing data results to be unreadable and out of SOP range. Q12347 Glycan: All peak concentrations in results were lower than specified in SOPs. Q12334 IEC: Fab domains were on the low side of the specified SOP range. Purpose Previous Issues Training Schedule Results Equipment Differences Acknowledgements Manager: Gary La Rowe Susan Lin Jeff Chou Bruce Mar Vanessa Ridgney- Cruz Jose Goin Introduction Rituximab is a genetically engineered monoclonal antibody directed against the CD20 antigen used to treat non- Hodgkins Lymphoma. Required by Genentech Available at Samsung Impact Solution Q12261 2100AN IS Laboratory Turbidimeter 2100 AN Models are different, AN IS is more sensitive than the AN AN IS will need to be purchased at Samsung Q12334 Waters HPLC 2695 with 2487/2489 UV Waters UPLC H-Class Differing HPLC systems Purchase new HPLC system Q12335 1.0 mL ASI Dynamic Mixer Not available Required to perform assay Purchase Q12345 Waters HPLC 2695 with 2487/2489 UV Waters UPLC H Class Differing HPLC systems Purchase new HPLC system Q12347 Beckman PA800 Beckman PA800 plus PA800 plus is newer and has same capability Method validation and transfer must occur to run Assay on this machine 5415C Micro- centrifuge 5415R Micro- centrifuge Different model, same capability N/A Water Bath 37°C and 55°C Water bath controlled from 25 to 75 +/- 2°C Different model, same capability N/A Q12350 Gel Dryer Assembly Not available Required to perform assay Purchase Light Box Not available Required to perform assay Purchase Samsung Biologics in Incheon, Korea has contracted with Roche to begin production of Rituximab because the worldwide demand for the drug remains high. To be produced and distributed Samsung, Analysts from the site will come to Vacaville Quality Control for two weeks to receive training and approval on the assays. Can Perfo rm SungHw Cho EunJi Joe Hana Jung Bomi Seol ChangUp Oh Conclusion The five Analysts successfully completed the training schedule and were approved for the assays they were assigned. Some completed engineering runs while other completed training runs on the reference standard. They are scheduled to return to Samsung to finish engineering runs and begin qualification runs by October of 2014. If equipment and method transfers go as planned, the production of Rituximab should begin in 2015.
