The Art and Science of Lyophilization
See how pharma experts use lyophilization technology to create lyophilized proteins and biologics. Learn about lyophilization (freeze-drying) and how it may be the answer to advancing your drug candidate to phase I clinical trials.
TECH-DRIVEN LYOPHILIZATION SERVICES
Lyophilization of proteins and biologics in vials ranging from 3mL to 50mL
Developing an effective lyophilization cycle is both art and science. Our skilled, experienced team of professionals, using Millrock lyophilization technology, provide critical synergies between the development lab and manufacturing line, ensuring your outcomes are met with the highest quality and always on time.
Lyophilization Cycle Development and Optimization: How to develop your protein or injectable in a lyophilized vial. Here are some common reasons why you should consider lyophization:
- An accomplished team to develop your lyophilization cycle technology-driven transfer from lab through production
- Flexible development-scale lyophilization technology suitable for a range of batch sizes
- Customized process evaluation capabilities for a variety of applications including developing analytical methods, manufacturing toxicology supplies, and stability testing
- Integrated software features provide process control and monitoring which enable real-time analysis and optimization
- Unparalleled ability to understand thermal events during the freezing and primary drying for continuous process protocol improvement and transfer
- From concept to commercial for small volume products ranging from 2ml to 50ml vials
Based on the stage of your lyophilization project, our scientists will help you determine if you need help with lyophilization cycle development, analytical methods, or stability testing. We can formulate and scale up a product with limited active supply.
Our team, led by Bryan Braxton, Ph.D, uses integrated software throughout our partnership to ensure process control and monitoring, which your team can leverage to track the progress of your lyophilization project from concept to commercial production
How lyophilization works, freezing, drying, secondary drying stages.
Request a Lyophilization Consultation with Our Scientists
The Art and Science of an Effective Lyophilization Cycle.
In order to provide the best possible transfer between the development-scale process and the production-scale process, we utilize Millrock lyophilization technology in the lab and in the production unit. This allows for the synergy of technology and engineering factors critical for scale-up and transfer activities.
CAPACITY: Our development-scale lyophilizer has a chamber suitable to produce a range of different batch sizes for evaluation of process parameters or producing supplies for various studies. These studies include but aren’t limited to the development of analytical methods, production of reference standards, non-pivotal toxicological supplies, and evaluation of stability.
ADVANCED SOFTWARE: The Accuflux™ and Autodry™ features for our Development-scale unit are powerful innovative tools that offer process control and monitoring for both the freezing and primary drying steps, enabling analysis and process optimization. This software is an improvement from much older software technologies on the market with other brands. Pii’s unit is also set up for the use of Freezebooster ™ technology.
Accuflux™ is a patented method of process monitoring and control that provides a direct measurement of heat flux. AccuFlux provides a new and valuable tool to understand the thermal events occurring during the freezing and primary drying steps. With direct and continuous measurement AccuFlux provides a continuous stream of your critical process parameters, for use in protocol improvement and transfer.
AutoDry™ is a patented method to control primary drying based on the product temperature. Optimize your cycle early for the highest throughput in the lab and in manufacturing.
FreezeBooster™ controlled nucleation enables the ability to study freezing approaches and their effect on the product and product cycle. Create a homogeneous cake across the batch to improve product quality and reduce primary drying time.
Skilled, experienced professionals powered by smart technology—Pii can serve your lyophilization project.