Rational Culture Media Design - BioProcess International
Expression and Production
Rational Culture Media Design™ A Method Integrating the Art and Science of Process Improvement
I
Formulation development is a combination of practical experience and the application of a practical, rational approach to media design. Applied Knowledge Base: using what we know to discover what we don’t know Data Driven: Results from each phase guide the design of the subsequent phase(s) Appropriate Methods: Carefully consider scale-down models and assays given to ensure relevance to the targeted large-scale process Predictive: Effective capture of key principles to avoid discovery of solutions limited to narrowly constrained conditions Efficient: Building on a foundation rich in experience. • Figure 1: Regression analysis of >30 design points allows for prediction of “Optima” Production
Growth
p
C
p
ou Gr
B
Gr ou
p
C
p
ou Gr
B
Growth
CD Batch Optimized FB
1
2
3
4
5
6
7
8
9
10 11 12 13 14
Figure 3: Phased approach to improvements; incremental process performance improvements are achieved at each project phase for both growth and production. Combined improvements resulted in a new process that produced more than seven times the yield of the original process (cumulative cell density in ×106 cell-days/mL). Cumulative Cell Density
CCD
8 7 6 5 4 3 2 1 0 0
Days
Optima
Titer
Gr ou
Figure 2: Direct comparison of growth performance between the original and newly improved process; this graph helps illustrate how the increase in cumulative cell density (cell-days/mL) for the new process is due both to a higher maximum viable cell density and increased culture 6 longevity 9 (viable cell density in ×10 cells/mL)
Growth Improvements by Phase PIV PV
80
1,600
70
1,400
60
PIII
50 40 30 20
PII P1
Titer (mg/mL)
R ational Culture Media Design™
Actual R esults
Viable Cell Density
rvine Scientific is committed to supporting the biopharmaceutical industry in the successful development and commercialization of biopharmaceutical products. A strong understanding of our media products is not the only basis for our successful supply, but the foundation of the innovation we provide to the market. Knowing innovation can result from the next big idea or an incremental change, we look for the small critical elements in our business that provide substantial process improvements and value to our customers. At Irvine Scientific our focus is to help the customer through the entire complex cell culture development process in order to achieve the ongoing optimum success they depend on.
Yield Improvements PV by Phase
1,200
PIV
1,000
PIII
800 600 400
10
200
0
0
PII P1
Jill Jermain is associate product manager for industrial cell culture at Irvine Scientific; 2511 Daimler Street, Santa Ana, CA 92705-5588; 949261-7800 ext. 234; [email protected]; www.irvinesci.com. 114 BioProcess International
Industry Yearbook 2011–2012
advertorial
Rational Culture Media Design™ A Method Integrating the Art and Science of Process Improvement
I
Formulation development is a combination of practical experience and the application of a practical, rational approach to media design. Applied Knowledge Base: using what we know to discover what we don’t know Data Driven: Results from each phase guide the design of the subsequent phase(s) Appropriate Methods: Carefully consider scale-down models and assays given to ensure relevance to the targeted large-scale process Predictive: Effective capture of key principles to avoid discovery of solutions limited to narrowly constrained conditions Efficient: Building on a foundation rich in experience. • Figure 1: Regression analysis of >30 design points allows for prediction of “Optima” Production
Growth
p
C
p
ou Gr
B
Gr ou
p
C
p
ou Gr
B
Growth
CD Batch Optimized FB
1
2
3
4
5
6
7
8
9
10 11 12 13 14
Figure 3: Phased approach to improvements; incremental process performance improvements are achieved at each project phase for both growth and production. Combined improvements resulted in a new process that produced more than seven times the yield of the original process (cumulative cell density in ×106 cell-days/mL). Cumulative Cell Density
CCD
8 7 6 5 4 3 2 1 0 0
Days
Optima
Titer
Gr ou
Figure 2: Direct comparison of growth performance between the original and newly improved process; this graph helps illustrate how the increase in cumulative cell density (cell-days/mL) for the new process is due both to a higher maximum viable cell density and increased culture 6 longevity 9 (viable cell density in ×10 cells/mL)
Growth Improvements by Phase PIV PV
80
1,600
70
1,400
60
PIII
50 40 30 20
PII P1
Titer (mg/mL)
R ational Culture Media Design™
Actual R esults
Viable Cell Density
rvine Scientific is committed to supporting the biopharmaceutical industry in the successful development and commercialization of biopharmaceutical products. A strong understanding of our media products is not the only basis for our successful supply, but the foundation of the innovation we provide to the market. Knowing innovation can result from the next big idea or an incremental change, we look for the small critical elements in our business that provide substantial process improvements and value to our customers. At Irvine Scientific our focus is to help the customer through the entire complex cell culture development process in order to achieve the ongoing optimum success they depend on.
Yield Improvements PV by Phase
1,200
PIV
1,000
PIII
800 600 400
10
200
0
0
PII P1
Jill Jermain is associate product manager for industrial cell culture at Irvine Scientific; 2511 Daimler Street, Santa Ana, CA 92705-5588; 949261-7800 ext. 234; [email protected]; www.irvinesci.com. 114 BioProcess International
Industry Yearbook 2011–2012
advertorial
