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Process Scale-Up

Remove the barriers to your scale-up process and accelerate time to market.

Benefits this Solution Provides

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Shorter Time to Market

Define a solid strategy and implementation plan to accelerate process scale-up and industrialization.

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Higher Standards of Development

Define the appropriate manufacturing process and its critical process parameters (CPPs).

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Data-Based Process Design Decisions

Produce an informative data set from an early stage to guide your process.

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Digitally Transformed Process

Use digital models to reproduce the production environment and processes.

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Understand Your Process Before Scaling Up

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  • Use design of experiments (DoE) early on to generate an advanced data set of the process. 
  • Characterize the process and understand how it will evolve. 
  • Obtain a comprehensive tech transfer document with important parameters of your process, analytical procedures, and critical quality attributes.  

Produce High-Quality Products at any Scale

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  • Reassess the quality attributes of the drug substance and drug product before scale-up.  
  • Check how the process will behave at the new scale and make any necessary adjustments. 
  • Make sure your products and processes meet strict regulatory requirements.

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Scale-Up Seamlessly

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  • Assess what is critical and what must be controlled in the first stages of development.  
  • Establish a robust control strategy for the scaled-up process. 
  • Document the tech transfer in depth.  
  • Define your process in a flexible digital model to start production easily.  

What Can You Expect From Implementing Our Solution?

Before After
The process is poorly defined, and process knowledge is limited, increasing the probability of an unsuccessful operation. The process is well defined and characterized before scaling up, minimizing risks.
Numerous elaborate experiments are needed. DoE allows you to minimize lengthy and costly assay activities.
The scale-up process is time-consuming and complex. The scale-up process is simplified and accelerated, and quality standards are maintained.

Learn More From Our Experts

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Blog Post

Generics and Biopharmaceuticals

Comparability for Post-Approval Changes

Read the Blog Post

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Industry Insight

Risk and Data as Knowledge Enablers: A Lifecycle Approach

Read the Article

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Webinar

How to Digitally Optimize Comparability for More Effective Post-Approval Change Management

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See how ValGenesis can support your digital transformation.