Validation of critical process input parameters in the production of protein pharmaceutical products: a strategy for validating new processes or revalidating existing processes.
Martin-Moe
S
S
Bayer Corporation, Berkeley, CA, USA.
Ellis
J
J
Coan
M
M
Victor
R
R
Savage
J
J
Bogren
N
N
Leng
B
B
Lee
C
C
Burnett
M
M
Montgomery
P
P
D011506:Proteins; D013678:Technology, Pharmaceutical
D011506:Proteins