Sartorius AG · XETR:SRT
Sartorius — Technical Presentation (May 2021)
19 slides from Sartorius's technical presentation, May 6, 2021
Slide 1: Piramal Webinar 6th May 2021
Piramal Webinar 6th May 2021 Erik Johansson
Slide 2: Introduction to MODDE 13
Introduction to MODDE® 13 Umetrics® Suite MODDE® is focused on delivering a full design of experiment solution, from creating an investigation plan to analyze results and support decision making base on scientific principles. MODDE® 13 is focused on improving Design Selection and making Optimization
Slide 3: Response and Factors
Response and Factors Factors Settings that define the volume of the design Drug Antibody Ratio is set up as Required Precision will influence the Design Space and Setpoint Required responses are quality attributes Exploration with hard apecifications that must be fulfilled. They define sweet spot, d
Slide 4: A Full Factorial Design with Worksheet
A Full Factorial Design with Worksheet The starting design is classical design. Full Factorial design with 16 experiments in corners and 3 center-points This design will give a model with 4 main terms and 6 interaction terms 4
Slide 5: Performed Experiments
Performed Experiments It is very common that the performed experiments varies to a small extent from the original Workset Here we can see that Protein Concentration and Temperature are spot on while pH and Reduction time vary to a small extent. MODDEs Condition number is used to measure the differen
Slide 6: Excellent Replicates in the Center Close to Target
Excellent Replicates in the Center Close to Target The replicates Blue Squares are close to Target Seventeen (17) of Nineteen (19) Experiment are inside the specifications A strong model as R2 and Q2 are high With many experiments inside specifications and a high R2 gives a high probability for a la
Slide 7: Slight Skewed Histogram
Slight Skewed Histogram Ideally the Histogram should look like a Gaussian curve Here it is slightly skewed but as the model R2/Q2 are both high this has a limited impact 7
Slide 8: Coefficients for First Model
Coefficients for First Model The first model has the 4 main terms and the six interaction terms The confidence bar passes zero for some of interaction terms and these will be scrutinized for removal 8
Slide 9: Model after Auto tune
Model after Auto tune Here we have removed the smallest coefficient There are two ways to continue • Removing the smallest coefficient and continue so until all coefficients are significant • The auto tune function is based on increasing the Q2. The auto tune function has two advantages • Fast and e
Slide 10: Summary of Fit Plot Describing an Excellent Model
Summary of Fit Plot Describing an Excellent Model The quality of the model is summarized with four bars • R2 describes how well the model fits to the data • Q2 describes how well the model can predict the data • Reproducibility is very high as the replicates was very close together • Model Validity
Slide 11: Observed vs Predicted Plot Describing an Excellent Model
Observed vs Predicted Plot Describing an Excellent Model With a R2 of 0.97 the experimental points will be very close to the line 11
Slide 12: 4-D Contour Plot
4-D Contour Plot This overview plot has been added to the Analysis wizard We can see that the lower left corner in the lower left plot are below the minimum value of 3.4. All the remaining area are within the specifications 12
Slide 13: Design Space Plot Gives You the Safe Area in Green
Design Space Plot Gives You the Safe Area in Green Design space is a part of MODDE that has become much more user user-friendly. The next part is to the find the area where the possibility of being within the specifications are high. In this case the acceptance level is 5% using the Prediction Inter
Slide 14: Robust Set-point is the Center of the Green Area
Robust Set-point is the Center of the Green Area The Robust Set-point is the point furthest away from any red area. This is usually the start point for production runs. Favorite Set-point is a point that the user find most practical or economical 14
Slide 15: Summary in numbers
Summary in numbers Robust set-point coordinates • Protein Concentration 10.20 mg/ml • Temperature 21.2 C • pH 7.32 • Reduction time 122.4 min Practical set-point • Protein Concentration 12.20 mg/ml • Temperature 20 C • pH 7.33 • Reduction time 115 min 15
Slide 16: Summary
Summary It is not common to get a large Design Space from a screening design, but this design did fulfill the important criteria Excellent chemical knowledge that supported the selection of appropriate factor ranges Good bookkeeping of experiments and entering the correct values into the Performed E
Slide 17: Acknowledgements
Acknowledgements ▪ Piramal ▪ Sartorius ▪ Eoin Gould ▪ Ian Schwartz ▪ Trayana Karadzhova ▪ Michel Szelwicki ▪ Vijay Kuppili ▪ Natasha Karol ▪ Priyadarshini Arora ▪ Chloe Lang ▪ Allan Davidson 17
Slide 18: Contact details
Contact details ▪ Piramal ▪ Sartorius Data Scientist contacts ▪ EMEA ▪ https://www.piramalpharmasolutions.com ▪ Chloe Lang ▪ Manager of Data Science EMEA ▪ Mobile: +45 2826 8682 Chloe Lang @sartorius.com ▪ contactus@piramal.com ▪ North America ▪ Scott Carpenter, M.S., Ph.D. ▪ Manager of Data Science
Slide 19: Thank you.
Thank you.