Cs DR Reddys Pharmaceutical Scale Up

CASE STUDY /
Ansys + Dr. Reddy’s

Laboratories
“Scale-up presents a significant challenge (both in time and money) in certain
pharmaceutical processes. Ansys helped us through multiple strategic consulting
projects in generating necessary process understanding and accurate scale-up
conditions for our mixing tanks to go from lab scale to plant scale. We received
valuable insights into the physics of scale-up and the risks involved. These simulations
helped us in decision-making on equipment sizing and cutting down on expensive
raw material usage for the testing process.”
RaviChandra Palaparthi
Head, Modeling and Simulation / Dr. Reddy’s Laboratories / Hyderabad, India
CASE STUDY
The pharmaceuticals industry faces diverse challenges, ranging from drug delivery to design
optimization of equipment to resolving scale-up problems. Dealing with increasing raw
material costs and the unavailability of the right raw materials at the right time creates major
issues in meeting stringent product delivery deadlines. Hence we explored engineering
simulations to help us address these challenges effectively.
Scale-Up Study for a Complex Generic

Drug Product
Dr. Reddy’s is a NYSE listed company, which manufactures and markets APIs,
Finished Dosages and Biologics in over 100 countries worldwide. Dr. Reddy’s is
a vertically integrated global pharmaceutical company with proven research
capabilities, including a promising drug discovery pipeline and presence across
the pharmaceutical value chain.
The company has expertise in scaling up complex products from lab to the
plant scale with an array of modeling tools. Process experts in the company
help in reducing the scale-up risks from lab to the plant.
/ Challenges
We engaged with Ansys to take advantage of their expertise in this field, so

we could get quicker results and learn faster. Ansys Consulting helped us to
develop accurate scale-up conditions by performing steady-state and transient
simulations at each scale, and studying parameters like velocity distributions,
mixing times and species concentrations from one scale to the other.
/ Technology Used
• Ansys CFD
• Ansys SpaceClaim
• Ansys Mesh
• Ansys Fluent
/ Engineering Solution
Ansys consultants used simulations to help us to understand:
• Differences in micro-, meso- and macro-mixing times from lab scale to plant
scale.
• Risks involved in the scale-up at each particular rpm level.
• Dead zone formation in plant scale simulations.
• The evolution of individual species concentration and mixing performance

using transient simulations.
Ansys + Dr. Reddy’s Laboratories // 2

/ Benefits
Consultation with Ansys on engineering simulations helped us in following ways:
• Providing valuable insights into the physics of scale-up and identifying the risks involved.
• Guiding in lowering the risk of scale-up batches.
• Helping make better informed decisions where minimal experimental data existed or where experimental data was difficult to get.
In one case, this translated into a 50% reduction in uncertainty in identifying the right process window even before we had the raw
material for experimentation.
• Facilitating the buy-in for engineering-based decision making from the non-engineers.
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Ansys + Dr. Reddy’s Laboratories // 3

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CASE STUDY /

Ansys + Dr. Reddy’s

Scale-Up Study for a Complex Generic

We engaged with Ansys to take advantage of their expertise in this field, so

• Risks involved in the scale-up at each particular rpm level.

• Dead zone formation in plant scale simulations.

• The evolution of individual species concentration and mixing performance

Ansys + Dr. Reddy’s Laboratories // 2

• Guiding in lowering the risk of scale-up batches.

Visit www.ansys.com for more information.

© 2021 ANSYS, Inc. All Rights Reserved.

Ansys + Dr. Reddy’s Laboratories // 3

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