Dynamis Medium Introduction

Transcription

1 Dynamis Medium Introduction Prepared for (customer name) PSM Name 1 The world leader in serving science

2 Gibco Dynamis Medium An excellent scale-up option for your CHO Cell Clones The Power to achieve higher titers The Power to start faster The Power to streamline scale-up Fill with Picture or graphic Fill with Picture or graphic Fill with Picture or graphic Dynamis medium provides the power to achieve higher titers, start faster, and streamline scale-up for upstream process development and bioprocessing. Is designed to provide the power to help you seamlessly scale-up 2 Dynamis means power in Greek

3 Dynamis medium enables highest titers at harvest Internal Clone IgG Titer Comparison on Harvest Day Glucose only fed-batch cultures show Dynamis medium achieved 74% higher titer compared to the next-best competitor, with highest growth in titer from day 14 to day 21 at 3% 3

4 VCD (E6 cells/ml) Enabling a faster & more sustained start with Dynamis medium Internal IgG Clone Viable Cell Density Culture time (days) Dynamis Medium ActiCHO P BalanCD CHO Growth A Medium Cellvento CHO-2 Medium EX-CELL CHOZN Medium HyCell CHO Medium PowerCHO 2 PowerCHO -GS Quick to reach 1E6 cells/ml and sustain that level days longer 4

5 Percent Viabile Cells Dynamis Medium Enables Highest Viability (Internal IgG Clone) 12 DG44 Viability 1 Dynamis Medium ActiCHO P 8 BalanCD CHO Growth A Medium 6 4 Cellvento CHO-2 Medium EX-CELL CHOZN Medium HyCell CHO Medium 2 PowerCHO 2 PowerCHO -GS Culture Time (Days) Glucose only fed-batch cultures show higher and more sustained viabilities 5

6 Dynamis Medium Enables Highest Viability (Internal IgG Clone) Glucose only fed-batch cultures show higher and more sustained viabilities 6

7 Glucose (g/l) Glucose Concentrations (Internal IgG Clone) 1 Glucose Concentration Dynamis Medium ActiCHO P BalanCD CHO Growth A Medium Cellvento CHO-2 Medium EX-CELL CHOZN Medium HyCell CHO Medium PowerCHO Culture Time (Days) PowerCHO -GS 3g/L glucose added if measured glucose was 3g/L in culture 6g/L glucose was added if glucose was 3g/L prior to a weekend 7

8 Lactate (g/l) Dynamis medium enables lactate consumption (Internal IgG Clone) 2.5 DG44 Lactate Concentration Dynamis Medium ActiCHO P BalanCD CHO Growth A Medium Cellvento CHO-2 Medium EX-CELL CHOZN Medium HyCell CHO Medium.5 PowerCHO Culture Time (Days) PowerCHO -GS Lactate is consumed early and continues to remain low until harvest 8

9 Glutamine (mmol/l) Glutamine Concentrations (Internal IgG Clone) 4 Glutamine Concentration Dynamis Medium ActiCHO P BalanCD CHO Growth A Medium Culture Time (Days) Cellvento CHO-2 Medium EX-CELL CHOZN Medium HyCell CHO Medium PowerCHO 2 PowerCHO -GS Gaps in data represent glutamine levels below the detection limit (lower limit of detection <.41 mmol/l) 9

10 Glutamate (mmol/l) Glutamate Concentrations (Internal IgG Clone) 4.5 Glutamate Concentration 4 Dynamis Medium ActiCHO P BalanCD CHO Growth A Medium Cellvento CHO-2 Medium EX-CELL CHOZN Medium HyCell CHO Medium Culture Time (Days) PowerCHO 2 PowerCHO -GS 1

11 Dynamis Ammonia Concentrations Comparable to Competitor Media (Internal IgG Clone) Ammonia (mmol/l) 12 Ammonia Concentration 1 Dynamis Medium ActiCHO P 8 BalanCD CHO Growth A Medium 6 4 Cellvento CHO-2 Medium EX-CELL CHOZN Medium HyCell CHO Medium 2 PowerCHO Culture Time (Days) PowerCHO -GS Ammonia concentration similar to competitor media 11

12 Dynamis medium enables highest titers in fed-batch culture Fed-batch cultures show up to 6% higher titers customer clone 12

13 AGT dry format simplicity helps streamline scale-up Key Benefits Auto ph: Just add Water No Add backs Required; single part Fast Dissolution and Mix Time Dust Free Addition to Tank Minimal Filtration Pressure Buildup AGT: Advanced Granulation Technology Dynamis AGT dry format product offers these time saving benefits 13

14 Comparable performance is seen when moving from CD FortiCHO medium to Dynamis medium VCD (x 1e6/mL) 18 Dynamis AGT Medium - Internal IgG Clone Growth Comparison to CD FortiCHO Medium Dynamis AGT Medium Lot Culture Time (Days) Dynamis AGT Medium Lot 2 CD FortiCHO Medium Lot 1 CD FortiCHO Medium Lot 2 CD FortiCHO Medium Lot 3 Dynamis medium provides a more scalable option 14

15 Comparable performance is seen when moving from CD FortiCHO medium to Dynamis medium Dynamis medium provides a more scalable option 15

16 Titer (mg/l) CD FortiCHO medium generated clones produce similarly in CD FortiCHO and Dynamis media Titer (mg/l) Freedom CHO-S Clones in SFB IgG-producing clones isolated using standard Freedom CHO-S workflow (in CD FortiCHO medium) Day 14 titers Clone 1 Clone 2 CD FortiCHO Dynamis SFB is simple fed-batch, glucose feeding only per Freedom CHO-S Manual standard protocol FB is fed-batch culture using CD EfficientFeed C supplement for feeding without optimization of conditions Freedom CHO-S Clones in FB Clone 1 Clone 2 CD FortiCHO Dynamis Dynamis medium helps to provide a seamless transition to production 16

17 Titer Relative to Early (%) CD FortiCHO medium generated clones are stable in CD FortiCHO and Dynamis media Titer Relative to Early (%) 4% Clone 1 Stability 4% Clone 2 Stability 3% 3% 2% 2% 1% 1% % % -1% -2% -3% -4% CD FortiCHO Dynamis Time (Generations) -1% -2% -3% -4% CD FortiCHO Dynamis Time (Generations) IgG-producing clones isolated using standard Freedom CHO-S workflow (in CD FortiCHO medium) Titer determined in stability cell train Dynamis medium does not alter clone stability 17

18 There is no significant change in product quality moving from CD FortiCHO medium to Dynamis medium % Glycan 9 Medium Comparison - DG44 IgG Glycan Analysis day11 - CD FortiCHO medium day 11- Dynamis medium day14 - CD FortiCHO medium day 14- Dynamis medium day17 - CD FortiCHO medium day 17- Dynamis medium Sample Day - Condition %GF %G1F %G2F %Man5/A1F 18

19 Dynamis medium for seamless process development scale-up Dynamis medium provides: The power to achieve higher titers The power to start faster The power to streamline scale-up Catalog Numbers Available: 1L AGT dry format A L AGT dry format A L AGT dry format A Kg AGT dry format A Transfer to Dynamis medium today! Caution: For manufacturing, processing or repacking. 19