Lyophilization Services: Cool Solutions for Complex Stability

This is lyophilization formulation development done right. Get optimal stability and quality for your parenteral drugs, and preserve sensitive formulations with our advanced freeze-drying technology. Our team works closely with clients to provide tailored solutions, so you can reduce risks and ensure efficient product commercialization—all without losing your cool.

Let’s Talk Lyo!

Stay Cool: Lyophilization Done Right

Benefits

Capabilities

Team up with Pii for

Top-notch Lyophilization Services: Get expert help with consistent formulation and process development from lab to scale-up and GMP production.
Full-scale Flexibility: From R&D lyophilization formulation development and beyond, access lyophilization equipment that is suitable for a range of batch sizes and available API quantities.
Customized Process Evaluation: Including developing early-stage, phase-appropriate analytical methods, manufacturing toxicology supplies, small-scale CTM, and supporting stability studies and testing.

Clinic to commercial, we have the lyophilization solution for you:

Millrock CIP/SIP Lyophilizer: 60 sq ft with a capacity of 3,000-20,000 units..
Millrock REVO-PRO Lyophilizer: 8 sq ft, ideal for cycle development and seamless to cGMP scale-up.
Concept-to-Clinic to Commercial: For small-volume products ranging from 3ml to 50ml vials.

Scaling Stability with Smart Lyophilization

A robust lyophilization formulation process is key to ensuring stability at scale. By optimizing freeze-drying conditions, products retain integrity, extend shelf life, and maintain quality from clinical to commercial production—meeting the demands of global supply.

View our Aseptic Fact Sheet

Custom lyophilization services and formulation development.

Expert-led lyophilization cycle development for success.

Clinical Trial Supply without the waste, providing 3mL to 50mL vials.

Commercial batch sizes up to 20k units.

In-house lyophilizers support clinical and commercial programs

20,000

Vial capacity for commercial or clinical

90%

of clients agree we delivered effective solutions

Lyophilization: Science Meets Stability

Freeze-drying isn’t just about keeping cool—it’s about keeping stable. This go-to method preserves thermolabile materials, transforming them into solid cakes that reconstitute effortlessly. Benefits include extended shelf life, reduced product weight for easier shipping, and stable formulations without excessive heat. Plus, the aseptic process eliminates contamination risks.

Learn More About Our Lyophilization Capabilities

From clinical through commercial, Pii has your lyophilization needs handled. Learn more about our equipment and processes.

Lyophilization Services at Pii

Lyophilization Services for Biologics

The demand for biopharmaceuticals like vaccines, proteins, and cell therapies is fueling the need for lyophilization to enhance stability and shelf life. Freeze drying is essential for large molecules prone to degradation, such as antibodies, peptides, and enzymes. By removing moisture under controlled conditions, lyophilization maintains product integrity and extends usability.

As complex biologics continue to emerge, the role of lyophilization in ensuring quality and longevity grows.

Got Questions?

Pii’s experts are here to keep it cool—contact us today!

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The Three Stages of the Lyophilization Cycle

For lyophilization done right, every freeze frame, partner with Pii for lyophilization as easy as 1,2,3.

Freezing Phase: Rapid freezing preserves material form by preventing large crystal formation, which could damage biological structures.
Primary Drying (Sublimation): Lowering pressure and adding heat allows sublimation to remove 95% of water, while vacuum and cold condenser protect the process.
Secondary Drying (Adsorption): Higher temperature removes bound water molecules, leaving a porous structure with 1-5% residual moisture.