1. 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 Q12334 Q12335 Q12345 Q12347 Q12350
Bomi Seol
ChangUp Oh
SungHwa Cho
EunJi Joe
Hana Jung
Tue Wed Thur Fri
7/21/2014 7/22/2014
7/23/201
4 7/24/2014 7/25/2014
Q12350
Training Day
1: Susan
Q12334
Training
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
Training
Day 3:
Susan
Q12335 Training
Day 2: Analysts
load and run
Mon Tue Wed Thur Fri
7/28/2014 7/29/2014
7/30/201
4 7/31/2014 8/1/2014
Q12347
Training Day
3: Wrap up
training run,
integration
and writeup
in am,
training run
#2 Day 1 in
pm
All
methods
practice
runs,
sandbox,
critical
reagent
prep, etc.
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
Patricia Lufburrow
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
Perform
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.