Shorten Time to Market with New Data-Driven Lyophilization Process

Partnering with a CDMO for lyophilization can shorten the drug development process and expedite time to market.


Shorten Time to Market with New Data-Driven Lyophilization Process

Lyophilization has become a necessary and effective component of drug product manufacturing across the pharmaceutical industry, driven by safety, quality, and stability. Lyophilization remains a complex process that poses particular challenges during tech transfer and scale-up, but newer, data-driven approaches offer more efficient routes to process optimization. The use of computation fluid dynamics (CFD) for modeling development, advanced analytics, and state-of-the-art GMP lyophilization equipment enables better understanding of the process and reduces the time required for optimization of robust, scalable lyophilization processes. Selecting the right manufacturing partner with appropriate lyophilization expertise, experience, and leading-edge data and analytical capabilities can reduce the drug development process and expedite time to market for lyophilized drugs.

Table of Contents

1 Safety, Quality, and Stability Drive Lyophilization

Master the challenges of manufacturing highly complex biologics.

2 Lyophilization Approval Landscape

Lyophilization is growing rapidly. Get ahead of the curve.

3 Challenging Scale-Up and Tech Transfer

Anticipating the demands of time-intensive scale-up and tech transfer.

4 Data-Driven Development Solutions

A look at modeling the complete lyophilization process—from the lab to the plant.

5 Advanced Analytics Invaluable

Advanced data analytics are critical to a full understanding of lyophilization.

6 Leveraging Single-Use Technology

Single-use systems condense tech transfer timeframes.

7 Importance of 100% Dose Control and Headspace Analysis

Ensure patient safety with fill volume and headspace content analysis.

8 Experienced Global Network Focused on Lyophilization Optimization

AbbVie is the leader in lyophilization scale-up and tech transfer.